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Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Recruiting
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Objective:
To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment.
Design:
This is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.
Stanford Investigators
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Non-myeloablative Allogeneic Transplantation +/- Allogeneic Idiotyped Pulsed Dendritic Cells for MM
Not Recruiting
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Mixed chimerism transplantation is an approach to allogeneic transplants that attempts to decrease regimen-related toxicity by using non-myeloablative preparatory regimens; establish mixed chimerism using low dose total body irradiation along with immunosuppression using cyclosporine and mycophenolate mofetil; suppress graft-vs-host and host-vs-graft reactions to allow a mixed chimeric state to be established, encourage tolerance and prevent graft-vs-host disease (GvHD) during the mixed chimerism period and use donor lymphocyte infusions to convert the patient to a full chimera while developing a graft-vs-tumor effect.
Stanford is currently not accepting patients for this trial.
For more information, please contact BMT Referrals, 6507230822.
Stanford Investigators
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Phase II Allogeneic CD8 Memory T-Cells Infusion as Consolidative Tx After HCT in Leukemia & Lymphoma
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This phase 2 trial studies how well cluster of differentiation 8 (CD8)+ memory T-cells work as a consolidative therapy following a donor non-myeloablative hematopoietic cell transplant in treating patients with leukemia or lymphoma. Giving total lymphoid irradiation and anti-thymocyte globulin before a donor hematopoietic cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of the donor's white blood cells, such as CD8+ memory T-cells, may boost this effect and may be an effective treatment to kill any cancer cells that may be left in the body (consolidative therapy).
Stanford is currently not accepting patients for this trial.
For more information, please contact Leah Galvez, 650-725-7951.
Stanford Investigators
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Phase I/II Anti-CD70CRISPR-Cas9-Engineered TCells(CTX130) in Relapsed/Refractory T/BCellMalignancies
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This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory T or B cell malignancies.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)
Not Recruiting
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To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Bone Marrow Grafting for Leukemia and Lymphoma
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The purpose of this study is to obtain tissue samples for ongoing studies regarding transplant outcomes and complications.
Lead Sponsor
Stanford Investigators
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Phase II Tabelecleucel in Epstein-BarrVirus-Associated Viremia /Malignancy Who Have No AlternativeTx
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The primary objective of this protocol is to provide expanded access to tabelecleucel to participants with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options, and who are not eligible to enroll in clinical studies designed to support the development and registration of tabelecleucel.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase II Donor Statin Tx for Prevention of Severe Acute GVHD after Myeloablative HCT
Not Recruiting
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This phase II trial studies donor atorvastatin treatment for the prevention of severe acute graft-versus-host disease (GVHD) in patients undergoing myeloablative peripheral blood stem cell (PBSC) transplantation. Giving chemotherapy and total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer cells. It may also prevent the patient's immune system reject the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving atorvastatin to the donor before transplant may prevent this from happening.
Stanford is currently not accepting patients for this trial.
For more information, please contact Leah Galvez, 650-725-7951.
Stanford Investigators
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Phase II Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG in MM
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To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.
Stanford is currently not accepting patients for this trial.
For more information, please contact BMT Referrals, 6507230822.
Lead Sponsor
Stanford Investigators
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TLI & ATG for Non-Myeloablative Allogeneic Transplantation for MDS and MPD
Not Recruiting
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To evaluate the feasibility and safety of TLI/ATG conditioning for allogeneic HCT for elderly patients with advanced stage MDS and MPD.
Stanford is currently not accepting patients for this trial.
For more information, please contact Physician Referrals, 650-723-0822.
Lead Sponsor
Stanford Investigators
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Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel
Recruiting
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The purpose of this expanded access protocol (EAP) is to provide controlled access to Afamitresgene autoleucel, suspension for intravenous infusion that does not meet the commercial release specification (NC afami-cel). This EAP will be conducted at authorized treatment centers where TECELRA® is being administered and where the EAP is approved to be conducted. Patients who are prescribed TECELRA® , sign the informed consent form, and meet all entry criteria will be eligible to participate in this protocol.
Stanford Investigators
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Transplantation for Patients with CLL
Not Recruiting
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To evaluate the role of high dose therapy and autologous or allogeneic hematopoietic cell transplantation for the treatment of chronic lymphocytic leukemia.
Stanford is currently not accepting patients for this trial.
For more information, please contact BMT Referrals, 6507230822.
Lead Sponsor
Stanford Investigators
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Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma
Not Recruiting
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The purpose of this trial is to develop an alternative treatment for patients with poor risk non-Hodgkin's lymphoma. This trial uses a combination of high dose chemotherapy with stem cell transplant using the patient's own cells. This is followed with non-myeloablative transplant using stem cells from a related or unrelated donor to try and generate an anti-lymphoma response from the new immune system.
Stanford is currently not accepting patients for this trial.
For more information, please contact Physician Referrals, 650-723-0822.
Lead Sponsor
Stanford Investigators
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Phase III FLT3Inhibitor Gilteritinib Maintenance Therapy After Allogeneic Transplant in FLT3/ITD AML
Not Recruiting
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The purpose of this study was to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who underwent hematopoietic stem cell transplant (HCT) and were randomized to receive gilteritinib or placebo beginning after the time of engraftment for a two year period.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase II Ruxolitinib in Combo w/ Corticosteroids in Steroid-Refractory Acute Graft-vs-Host Disease
Not Recruiting
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The purpose of this study was to assess the efficacy of ruxolitinib in combination with corticosteroids in subjects with Grades II to IV steroid-refractory acute graft-versus-host disease (GVHD).
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Protocol for Research DB for HCT, Other Cellular Therapies and Marrow Toxic Injuries
Recruiting
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The primary purpose of the Research Database is to have a comprehensive source of observational data that can be used to study HSC transplantation and cellular therapies.
A secondary purpose of the Research Database is to have a comprehensive source of data to study marrow toxic injuries.
Objectives:
To learn more about what makes stem cell transplants and cellular therapies work well such as:
* Determine how well recipients recover from their transplants or cellular therapy;
* Determine how recovery after a transplant or cellular therapy can be improved;
* Determine how a donor's or recipient's genetics impact recipient recovery after a transplant or cellular therapy;
* Determine how access to transplant or cellular therapy for different groups of patients can be improved;
* Determine how well donors recover from the collection procedures.
Stanford Investigators
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Extension LTFU & Lenalidomide Maintenance Tx for Enrollees on BMT CTN 0702
Not Recruiting
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This study is designed to compare long-term outcomes among patients randomized on the BMT CTN 0702 protocol (NCT01109004), "A Trial of Single Autologous Transplant with or without Consolidation Therapy versus Tandem Autologous Transplant with Lenalidomide Maintenance for Patients with Multiple Myeloma". It is hypothesized that use of novel anti-myeloma agents will improve long-term progression-free survival (PFS) after high-dose melphalan followed by autologous hematopoietic cell transplantation (HCT) as compared to a second autologous transplantation.
Stanford is currently not accepting patients for this trial.
For more information, please contact Kashif Naseem, 650-724-3155.
Stanford Investigators
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Phase II KTE-X19 in Relapsed/Refractory Mantle Cell Lymphoma
Not Recruiting
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The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors
Recruiting
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This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX131™ in subjects with relapsed or refractory solid tumors.
Stanford Investigators
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Phase II: HD Chemo + Allo Hematopoietic Cell Transplant for NHL
Not Recruiting
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To evaluate the role of allogeneic hematopoietic cell transplantation in the treatment of NHL.
Stanford is currently not accepting patients for this trial.
For more information, please contact BMT Referrals, 6507230822.
Lead Sponsor
Stanford Investigators
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Phase III Standard-Dose Combo Chemo or High-Dose Combo Chemo +Stem Cell T-plant in Germ Cell Tumors
Not Recruiting
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This randomized phase III trial studies how well standard-dose combination chemotherapy works compared to high-dose combination chemotherapy and stem cell transplant in treating patients with germ cell tumors that have returned after a period of improvement or did not respond to treatment. Drugs used in chemotherapy, such as paclitaxel, ifosfamide, cisplatin, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim or pegfilgrastim, and certain chemotherapy drugs, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. It is not yet known whether high-dose combination chemotherapy and stem cell transplant are more effective than standard-dose combination chemotherapy in treating patients with refractory or relapsed germ cell tumors.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase I Primary T Regulatory Cell Tx to Treat Visceral Acute GVHD After HCT
Not Recruiting
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This phase I trial studies the side effects and best dose of donor regulatory T cells in treating patients with graft-versus-host disease affecting the liver or gastrointestinal organs (visceral) within 100 days (acute) after undergoing a stem cell transplant. Graft-versus-host disease occurs when donor immune cells infused in a stem cell transplant attack the gut, skin, liver, or other organ systems of the patient. Regulatory T cells are a type of immune cell that may be able to reduce the attack of the donor's immune cells on the patient's normal cells and help treat graft-vs-host disease.
Stanford is currently not accepting patients for this trial.
For more information, please contact Joanne Otani, 650-721-2372.
Stanford Investigators
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Phase III Umbilical Cord Blood vs Bone Marrow in Hematologic Malignancies
Not Recruiting
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Hematopoietic cell transplants (HCT)are one treatment option for people with leukemia or lymphoma. Family members,unrelated donors or banked umbilical cordblood units with similar tissue type can be used for HCT. This study will compare the effectiveness of two new types of bone marrow transplants in people with leukemia or lymphoma: one that uses bone marrow donated from family members with only partially matched bone marrow; and, one that uses two partially matched cord blood units.
Stanford is currently not accepting patients for this trial.
For more information, please contact Physician Referrals, 650-723-0822.
Stanford Investigators
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Single Autologous Tplant +/- Consolidation Therapy VS Tandem Autologous Tplant +Lenalidomide for MM
Not Recruiting
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The study is designed as a Phase III, multicenter trial of tandem autologous transplants plus maintenance therapy versus the strategy of single autologous transplant plus consolidation therapy with lenalidomide, bortezomib and dexamethasone (RVD) followed by maintenance therapy or single autologous transplant plus maintenance therapy as part of upfront treatment of multiple myeloma (MM). Lenalidomide will be used as maintenance therapy for three years in all arms.
Stanford is currently not accepting patients for this trial.
For more information, please contact Physician Referrals, 6507230822.
Stanford Investigators
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Clinical and Pathologic Studies in Non-Hodgkin's Lymphoma Patients Receiving Antibody Treatment
Not Recruiting
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To characterize the molecular and cell biology of the tumor cells in lymphoma. The mechanism of monoclonal antibody treatment by rituximab or epratuzumab will also be examined.
Stanford is currently not accepting patients for this trial.
For more information, please contact Mayita Romero, 6507256452.
Lead Sponsor
Stanford Investigators
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Phase 2 Poor Risk DLBCL of TLI and ATG Followed by Matched Allogeneic HT as Consolidation to Autologous HCT
Not Recruiting
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The purpose of this study is to determine if double autologous then allogeneic hematopoietic cell transplant may offer an improved treatment option for patients with relapsed diffuse large B-cell lymphoma (DLBCL) who are not likely to be cured by the conventional transplantation regimen.
Stanford is currently not accepting patients for this trial.
For more information, please contact BMT Referrals, 6507230822.
Lead Sponsor
Stanford Investigators
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Phase III Axicabtagene Ciloleucel vs SoC Therapy in Relapsed/Refractory Diffuse Large BCell Lymphoma
Not Recruiting
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The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase II Obinutuzumab in Prevention of cGVHD After Allogeneic Peripheral Blood Stem Cell Transplant
Not Recruiting
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This research study is studying a drug called obinutuzumab as a means of preventing chronic Graft vs. Host Disease (cGVHD).
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Allogeneic HCT vs Hypomethylating Tx or Best Supportive Care in High Risk MDS
Not Recruiting
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This study is designed as a multicenter trial, with biological assignment to one of two study arms; Arm 1: Reduced intensity conditioning allogeneic hematopoietic cell transplantation (RIC-alloHCT), Arm 2: Non-Transplant Therapy/Best Supportive Care.
Stanford is currently not accepting patients for this trial.
For more information, please contact Physician Referrals, 650-723-0822.
Stanford Investigators
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Phase II Novel Approaches for GVHD Prevention Compared to Contemporary Controls
Not Recruiting
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Acute Graft-versus-Host-Disease (GVHD) is an important cause of morbidity and mortality after allogeneic hematopoietic stem cell transplantation (HSCT). This study aims to determine if any of three new GVHD prophylaxis approaches improves the rate of GVHD and relapse free survival at one year after transplant compared to the current standard prophylaxis regimen.
Stanford is currently not accepting patients for this trial.
For more information, please contact Physician Referrals, 650-723-0822.
Stanford Investigators
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Allogeneic Transplantation Using TLI & ATG for Older Patients with Hematologic Malignancies
Not Recruiting
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To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GvHD) occurs.
Stanford is currently not accepting patients for this trial.
For more information, please contact Physician Referrals, 650-723-0822.
Lead Sponsor
Stanford Investigators
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Expanded Access KTE-X19 in Relapsed/Refractory B-Cell Malignancies
Not Recruiting
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The primary objectives of this study are:
Cohort 1: to provide access to brexucabtagene autoleucel (KTE-X19) for individuals with relapsed or refractory (r/r) mantle cell lymphoma (MCL) until KTE-X19 is commercially available
Cohort 2: To provide access to KTE-X19 for individuals with r/r MCL whose commercially manufactured product did not meet commercial release specification(s)
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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Phase I/II KTE-C19 in Combo w/ Atezolizumab in Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Not Recruiting
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The primary objective of phase 1 is to evaluate the safety of KTE-C19 and atezolizumab combination regimens.
The primary objective of phase 2 is to evaluate the efficacy of KTE-C19 and atezolizumab, as measured by complete response rate in participants with refractory diffuse large B-cell lymphoma (DLBCL).
Participants who received an infusion of KTE-C19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968 (NCT05041309).
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Stanford Investigators
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A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression
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The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\*02 expression.
The main questions this study aims to answer are:
* Phase 1: What is the recommended dose of A2B395 that is safe for patients
* Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy cells
Participants will be required to perform study procedures and assessments, and will also receive the following study treatments:
* Enrollment in BASECAMP-1 (NCT04981119)
* Preconditioning lymphodepletion (PCLD) regimen
* A2B395 Tmod CAR T cells at the assigned dose
Stanford Investigators
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Phase II Optimizing Post-Alogeneic HCT Outcomes in Lymphoma Using Ibrutinib
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This phase II trial studies how well ibrutinib works in treating patients after a donor stem cell transplant for lymphoma that is not responding to treatment or has come back. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Stanford is currently not accepting patients for this trial.
For more information, please contact David Miklos, M.D., .
Stanford Investigators
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Phase 1/2 Safety and Efficacy of CTX131 in Adults with Hematologic Malignancies
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This is an open label, multicenter, phase 1/2 dose evaluation and cohort expansion study evaluating the safety and efficacy of CTX131 in subjects with Relapsed/Refractory Hematologic Malignancies
Stanford is currently not accepting patients for this trial.
For more information, please contact Vivian Leung, 650-723-8653.
Stanford Investigators
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Long-term Follow-up Study of Subjects w/ Malignancies Treated With CRISPR CAR Cellular Therapies
Recruiting
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This study will evaluate the long-term safety and efficacy of CRISPR CAR T cellular therapies
Stanford Investigators
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Phase I/II Anti-CD7 CAR-TCells in R/R T-Cell AcuteLymphoblasticLeukemia/T-Cell LymphoblasticLymphoma
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This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of BEAM-201 in patients with relapsed/refractory T-ALL or T-LL. This study consists of Phase 1 dose-exploration cohorts, Phase 1 dose-expansion cohort(s), a Phase 1 pediatric cohort (will enroll patients ages 1 to \< 12 years), and a Phase 2 cohort.
Stanford is currently not accepting patients for this trial.
For more information, please contact Vivian Leung, .
Stanford Investigators
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Phase II Non-myeloablative Allogeneic Transplant Using TLI & ATG In Cutaneous T Cell Lymphoma
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Non-myeloablative approach for allogeneic transplant is a reasonable option, especially given that the median age at diagnosis is 55-60 years and frequently present compromised skin in these patients, which increases the risk of infection. Therefore, we propose a clinical study with allogeneic hematopoietic stem cell transplantation (HSCT) using a unique non-myeloablative preparative regimen, TLI/ATG, to treat advanced mycosis fungoides/Sezary syndrome (MF/SS).
Stanford is currently not accepting patients for this trial.
For more information, please contact Michelle Chin, 650-721-4183.
Lead Sponsor
Stanford Investigators
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