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Dr. Gabriel Mannis is Assistant Professor of Medicine in the Division of Hematology at Stanford University School of Medicine, and Medical Director of Stanford’s Inpatient Leukemia Service. He specializes in the treatment of acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS), and other hematologic malignancies. As a clinical scientist, Dr. Mannis divides his time between caring for patients, teaching trainees, and researching novel therapies for AML and MDS. Dr. Mannis has co-authored numerous publications on topics including AML, hematopoietic cell transplantation, and advanced care planning for patients with hematologic malignancies. Currently, Dr. Mannis serves on the National Comprehensive Cancer Network AML panel, helping to write evidence-based guidelines for how AML is best treated. He oversees the AML clinical trial portfolio at Stanford, with multiple clinical trials of novel drugs actively enrolling for both newly diagnosed and relapsed or refractory AML.
My research focuses on the development of more effective, less toxic therapies for patients with AML and other high-risk hematologic malignancies. We study biologic correlates that predict response to therapy as well as factors/interventions that improve quality-of-life for patients struggling with blood-borne cancers.
Study of IMGN632 in Patients With Untreated BPDCN and Relapsed/Refractory BPDCN
This is an open-label, multi-center, Phase 1/2 study to determine the MTD and assess the
safety, tolerability, PK, immunogenicity, and anti-leukemia activity of IMGN632 when
administered as monotherapy to patients with CD123+ disease.
The study is enrolling a pivotal cohort of frontline BPDCN patients and a cohort of
relapsed/refractory BPDCN patients.
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A Study to Assess the Effect of CC-95251 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndromes
The purpose of this study is to evaluate the safety, tolerability, and preliminary clinical
activity of CC-95251 alone and in combination with antineoplastic agents in participants with
relapsed or refractory acute myeloid leukemia and relapsed or refractory and treatment-naive
higher risk melodysplastic syndromes.
Stanford is currently not accepting patients for this trial.
For more information, please contact Cancer Clinical Trials Office (CCTO), 650-498-7061.
Study of Magrolimab Combinations in Participants With Myeloid Malignancies
The primary objectives of this study are to evaluate the safety, tolerability and to
determine the recommended Phase 2 dose (RP2D) of magrolimab (Mag) in combination with the
anti-leukemia therapies of venetoclax (Ven) and azacitidine (Aza) (Cohort 1), mitoxantrone,
etoposide, and cytarabine (MEC) (Cohort 2) and CC-486 (Cohort 3) respectively in participants
with acute myeloid leukemia (AML), to evaluate the efficacy of magrolimab in combination with
the anti-leukemia therapies as determined by the rate of complete remission (CR) (Phase 2
Cohorts 1 and 2), and/or complete remission with incomplete hematologic recovery (CRi)
(CR/CRi) (Phase 2 Cohort 2) and to evaluate the efficacy of magrolimab in combination with
anti-leukemia therapy CC-486 as determined by the minimal residual disease (MRD) negative CR
rate (Phase 2 Cohort 3).
A Study of SNDX-5613 in R/R Leukemias Including Those With an MLLr/KMT2A Gene Rearrangement or NPM1 Mutation
Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase
2 dose (RP2D) of SNDX-5613 in patients with acute leukemia.
In Phase 2, patients will be enrolled in 3 indication-specific expansion cohorts to determine
the efficacy, short- and long-term safety, and tolerability of SNDX-5613.
Feasibility of Telehealth Palliative Care and Digital Symptom Monitoring for Patients With Acute Myeloid Leukemia
AML is the most common leukemia diagnosed in adults. In spite of recent low-intensity
therapies that have improved outcomes for older AML patients, AML remains associated with
poor prognosis as well as high symptom burden. While the benefits of early palliative care as
well as electronic PROs have been well-described in the oncology population, neither have
been well-studied in the AML population, and have never been studied in combination. We
propose a prospective, single-center, single-arm trial to evaluate the feasibility of a
virtually-mediated supportive care model utilizing both electronic PROs and palliative care
for patients with AML being treated with low-intensity therapy.
AIM1: is to evaluate and describe the feasibility of implementing early specialty palliative
care referrals carried out via telehealth/video-based modalities in combination with digital
symptom monitoring for patients recently diagnosed with acute myeloid leukemia (AML) and
starting low intensity induction therapy.
AIM2: study the differences in health-related quality-of-life (HRQoL) metrics using
patient-reported outcomes (PROs) in patients recently diagnosed with AML and starting low
intensity induction therapy who receive early referral to telehealth/video-based palliative
care visits compared to standard care.
AIM3: to explore the patient experience of patients with AML on low-intensity therapy,
capture rates of advance care planning, hospice utilization, and hospital utilization.
A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia
JZP025-101 is an open-label, multicenter, multi-arm, nonrandomized phase 1b master trial to
determine the recommended phase 2 dose (RP2D) of CPX-351 when administered in combination
with various targeted agents in previously untreated subjects with Acute Myeloid Leukemia
(AML) who are fit to receive intensive chemotherapy (ICT). Subjects will be assigned to
treatment arms based on results of AML mutation testing.
Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia
This study will evaluate the efficacy of uproleselan (GMI-1271), a specific E-selectin
antagonist, in combination with chemotherapy to treat relapsed/refractory AML, compared to
chemotherapy alone. The safety of uproleselan when given with chemotherapy will also be
investigated in patients with relapsed/refractory AML
Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)
The Phase 1 portion of this study is a single-arm, open-label, multicenter, non-randomized
interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and efficacy
of ASTX727 when given in combination with venetoclax for the treatment of newly diagnosed
acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have
comorbidities that preclude use of intensive induction chemotherapy. The primary purpose of
the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination
therapy by evaluating area under the curve (AUC) and maximum plasma concentration (Cmax)
The Phase 2 portion of the study is to assess the efficacy of ASTX727 and venetoclax when
given in combination and to evaluate potential PK interactions. Phase 2 will follow the same
overall study design as Phase 1.
Stanford is currently not accepting patients for this trial.
For more information, please contact Gabriel Mannis, 650-498-6000.
IO-202 as Monotherapy and IO-202 Plus Azacitidine in Patients in AML and CMML
To assess safety and tolerability at increasing dose levels of IO-202 as monotherapy and in
combination with Azacitidine in successive cohorts of participants with relapsed or
refractory AML with monocytic differentiation and CMML in order to estimate the maximum
tolerated dose (MTD) or maximum administered dose (MAD) and select the recommended Phase 2
dose (RP2D) and dose schedule as monotherapy and combination therapy.
Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Participants With Hematological Malignancies
The primary objectives of this study are:
- To confirm the safety and tolerability of magrolimab monotherapy in a
relapsed/refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome
(MDS) population, and of magrolimab in combination with azacitidine in previously
untreated participants with AML or MDS and participants with R/R AML and MDS
- To evaluate the efficacy of magrolimab monotherapy in R/R AML/MDS, and of magrolimab in
combination with azacitidine in previously untreated participants with AML/MDS, or R/R
AML/MDS as measured by complete remission (CR) rate for participants with AML and
higher-risk MDS, and duration of complete response for participants with AML and
higher-risk MDS, and duration of CR for participants with AML and higher-risk MDS
- To evaluate the safety, tolerability, and efficacy of magrolimab monotherapy or
combination with azacitidine in low-risk MDS participants as measured by red blood cell
(RBC) transfusion independence rate