A Phase 1/2a, Open-Label, Multicenter, Dose-Escalation Study to Evaluate the Safety and Tolerability of Intravenous Administration of RGI-2001 in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (AHSCT)

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of RGI-2001 in patients undergoing Allogenic Hematopoietic Stem Cell Transplantation (AHSCT), with radiation or non-radiation myeloablative preparative treatment. RGI-2001 is an investigational drug (not yet approved by the Food and Drug Administration). RGI-2001modulates (alters) the immune system and may help the donor immune system adjust to your body tissues. RGI-2001 has the potential to reduce the risk of acute graft versus host disease. This is the first study of RGI-2001 in humans.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : RGI-2001

Phase: Phase 1/Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

1. Subject has a hematological malignancy or aplastic anemia (AA) and is undergoing a first allogeneic transplant procedure. 2. Meet one of the following underlying disease criteria: a. Acute myelogenous leukemia (AML) i. First or subsequent morphologic remission b. Acute lymphoblastic leukemia (ALL) i. First or subsequent morphologic remission c. Chronic myelogenous leukemia (CML) i. Chronic phase; or ii. Accelerated phase d. Multiple Myeloma (MM) i. Not more than 20% plasma cells in the bone marrow e. Myelodysplastic syndrome (MDS), including chronic myelomonocytic leukemia (CMML), who have received at least one previous induction regimen and have <10% blasts f. Myeloproliferative disorder (MPD), including; i. myeloid metaplasia, and ii. myelofibrosis g. Non-Hodgkin's Lymphoma (NHL) i. High-risk NHL in first remission; or ii. Relapsed or refractory NHL h. Hodgkin's lymphoma (HL) beyond first remission i. Aplastic anemia (AA) 3. Male or female, age ?18 years of age 4. Reasonable expectation of survival for at least 3 months, if the transplant procedure is successful 5. Eastern Cooperative Oncology Group (ECOG) status of 0-2 or Karnofsky Performance Status (KPS) of > 60 6. Transplant Donor 1. Part 1 (Phase 1: Dose Escalation Phase): Unrelated transplant donor with no more than 1 HLA allele or antigen mismatch, defined as loci A, B, C and DR (note: DQ is excluded) 2. Part 2 (Phase 2a: Expansion Phase):Related or unrelated transplant donor, with no more than 1 HLA allele or antigen mismatch, defined as loci A, B, C and DR (note: DQ is excluded). 7. Source of the allograft 1. Part 1 (Phase 1: Dose Escalation Phase):Unmodified (non-manipulated) bone marrow, or mobilized peripheral blood stem cell (PBSC) transplant, using G-CSF as the mobilizing agent. 2. Part 2: (Phase 2a: Expansion Phase) Unmodified (non-manipulated) bone marrow, or mobilized peripheral blood stem cell (PBSC) transplant, using G-CSF as the mobilizing agent. 8. Anti-graft-versus-host disease (GvHD) prophylaxis: A calcineurin inhibitor [either tacrolimus (FK506) or cyclosporin A)], in combination with either methotrexate (MTX), mycophenolate mofetil (MMF) or sirolimus (RAPA) all at doses as per the institutional protocols 9. Adequate hepatic function, with bilirubin not exceeding the upper limit of normal (except when attributed to Gilbert's Disease), and AST and ALT of less than 1.5 times the upper limit of normal 10. No clinically significant cardiac conduction disorder on screening ECG 11. Serum creatinine ? 2.0 mg/dL 12. Female patients of childbearing potential must have a negative serum pregnancy test prior to enrollment and must agree to use dual method of contraception for 30 days after study drug administration. Approved methods of contraception include, an IUD with spermicide, a female condom with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, use of a condom with spermicide by sexual partner or a sterile sexual partner. 13. If male, subjects must be sterile or willing to use an approved method of contraception from the time of Informed Consent to 30 days after study drug treatment. Males must be willing to refrain from sperm donation within 30 days after study drug treatment. 14. No clinically significant acute or chronic medical condition that in the opinion of the investigator will interfere with study participation 15. No clinically significant laboratory abnormalities as determined by the Principal Investigator, in consultation with the Sponsor's Medical Monitor 16. No active infection 17. Have signed written informed consent before undergoing any study related procedures and is willing to comply with all study procedures

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