Clinical trials: R/R AML
AML M4, AML M5
Clinical Study of Anti-ILT3 CAR-T Therapy for R/R AML(M4/M5)
This study evaluates the safety and efficacy of novel ILT3-targeted CAR-T cell therapy for patients with relapsed or refractory acute myeloid leukemia (M4/M5).
- Trial name
- NCT04803929
- Testing
- anti-ILT3 CAR-T
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Carbiogene Therapeutics Co. Ltd.
Acute Myeloid Leukemia
Study of IBR733 Cell Injection in Acute Myeloid Leukemia
This is an open-label clinical study: phase Ia is the dose-escalation part, and phase Ib is the dose-expansion part. The phase Ia study is to evaluate the safety, tolerability, recommended phase II dose, pharmacokinetics…
- Trial name
- NCT06234904
- Testing
- IBR733 Cell Injection
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Imbioray (Hangzhou) Biomedicine Co., Ltd.
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation
Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Lineage Acute Leukemia, Mixed Phenotype Acute Leukemia
- Trial name
- AUGMENT-101 (NCT04065399)
- Testing
- revumenib, cobicistat
- Where
- 57 sites in United States, Australia and 9 more
- Volunteers
- 447 people
- Sponsor
- Syndax Pharmaceuticals
Relapsed or Refractory Acute Myeloid Leukemia
A China Bridging Study of Ivosidenib in r/r AML Subjects With an IDH1 Mutation
This is a phase 1, multi-center, single-arm study to evaluate the pharmacokinetics(PK)/ pharmacodynamics(PD), safety, and clinical efficacy of orally administered Ivosidenib in Chinese subjects with R/R AML with an IDH1 mutation.
- Trial name
- NCT04176393
- Testing
- ivosidenib
- Where
- China
- Volunteers
- 30 people
- Sponsor
- CStone Pharmaceuticals
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory
Phase 1 Study of Allo-RevCAR01-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies (1b Dose Expansion)
The Allo-RevCAR01-T-CD123 drug is a combination of a cellular component (Allo-RevCAR01-T) with a recombinant antibody derivative (R-TM123), which together form the active drug.
- Trial name
- RevSTAR-123 (NCT05949125)
- Testing
- Cyclophosphamide (Non-IMP, Lymphodepletion), Fludarabine (Non-IMP, Lymphodepletion), R-TM123
- Where
- 15 sites in Germany, Netherlands
- Volunteers
- 37 people
- Sponsor
- AvenCell Europe GmbH
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory
Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS
This is a phase I/2, interventional, open-label, multicenter study to assess the safety and efficacy of ARD103 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.
- Conditions
- Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory, MDS (Myelodysplastic Syndrome)
- Trial name
- NCT06680752
- Testing
- ARD103, Cyclophosphamide, Fludarabine
- Where
- 3 sites in United States
- Volunteers
- 49 people
- Sponsor
- ARCE Therapeutics, Inc.
Relapsed/Refractory AML
Study to Evaluate PK and Safety With Uproleselan Combined With Chemotherapy to Treat Chinese R/R AML Patients
This study will evaluate the safety and tolerability of uproleselan(GMI-1271), a specific E-selectin antagonist, and characterize the pharmacokinetic (PK) profile of uproleselan, in combination with chemotherapy to treat Chinese…
- Trial name
- NCT04839341
- Testing
- Uproleselan
- Where
- 2 sites in China
- Volunteers
- 12 people
- Sponsor
- Apollomics Inc.
Acute Myeloid Leukemia, Lymphoid Leukemia
Oshadi D & Oshadi R Combined With Salvage Chemotherapy for Relapsed Acute Myeloid Leukemia or Lymphoid Leukemia Patients
The study will be a prospective open-label single-center study in previously treated patients with Acute Myeloid Leukemia (AML) or Acute Lymphoid Leukemia (ALL).
- Trial name
- NCT02462265
- Testing
- Oshadi D & Oshadi R;, salvage therapy cytosar and mitoxantrone
- Volunteers
- 15 people
- Sponsor
- Oshadi Drug Administration
Leukaemia
First in Human Testing of Dose-escalation of SAR440234 in Patients With Acute Myeloid Leukemia, Acute Lymphoid Leukemia and Myelodysplastic Syndrome
Primary Objective: Dose escalation: To determine the maximum tolerated dose (MTD) of SAR440234 administered as a single agent in participants with relapsed or refractory acute myeloid leukemia (R/R AML), high risk myelodysplastic…
- Trial name
- NCT03594955
- Testing
- SAR440234
- Where
- 4 sites in United States, France
- Volunteers
- 7 people
- Sponsor
- Sanofi
ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myeloid Leukemia)
PRAISE-IR Versus CIBMTR Controls
The rationale to conduct this RWE study is to provide data to support the safety of CD34 selected grafts versus T replete PBSC transplants to address concerns about increased TRM in CD34 selected graft recipients.
- Conditions
- ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myeloid Leukemia), MDS (Myelodysplastic Syndrome)
- Trial name
- NCT07717164
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Miltenyi Biomedicine GmbH
AML, Adult, MDS
Phase 2, Open-Label, Single Arm Study, With BST-236 in Adults With R/R AML or Higher-Risk MDS
An open label multi center study to assess the safety and efficacy of BST-236 as single agent in adult patients unfit for standard therapy with Acute Myeloid Leukemia (AML) or higher-risk (HR) Myelodysplastic Syndromes (MDS) who…
- Conditions
- AML, Adult, MDS, Relapse/Recurrence, Refractory Acute Myeloid Leukemia
- Trial name
- NCT04749355
- Testing
- BST-236
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- BioSight Ltd.
Acute Myeloid Leukemia (AML)
Anti-CD33-CLL1 CAR-T Cells (ICG415) for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
This single-arm, open-label phase I trial evaluates the safety and tolerability of ICG415, autologous CAR-T cells targeting CD33 and CLL1, in patients with relapsed or refractory acute myeloid leukemia (AML).
- Trial name
- ICG415-AML-01 (NCT07668557)
- Testing
- Anti-CD33-CLL1 CAR-T cells (ICG415) following lymphodepleting fludarabine and cyclophosphamide
- Where
- 2 sites in China
- Volunteers
- 18 people
- Sponsor
- iCell Gene Therapeutics
Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
A Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib or Venetoclax in Participants With R/R Hematologic Malignancies
This is a Phase 1 dose-escalation study of PRT2527, a potent and highly selective cyclin-dependent kinase (CDK) 9 inhibitor, in participants with select relapsed or refractory (R/R) hematologic malignancies.
- Conditions
- Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma (MCL), Richter's Syndrome
- Trial name
- NCT05665530
- Testing
- PRT2527, Zanubrutinib, Venetoclax
- Where
- 24 sites in United States, Australia and 8 more
- Volunteers
- 86 people
- Sponsor
- Prelude Therapeutics Incorporated
Leukemia, Myeloid, Acute
HDM201 Added to CT in R/R or Newly Diagnosed AML
This is a multi-center open-label Phase I/II study investigating orally administered HDM201 in combination with chemotherapy in two populations: subjects with first line AML or subjects with relapsed/refractory AML.
- Trial name
- NCT03760445
- Testing
- HDM201, cytarabine, anthracycline
- Sponsor
- Novartis Pharmaceuticals
Relapsed Acute Myeloid Leukemia (AML), Refractory Acute Myeloid Leukemia (AML)
Phase 1 Study of AUTX-703 in Relapsed/Refractory AML and MDS
This Phase 1, multicenter, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of AUTX-703…
- Conditions
- Relapsed Acute Myeloid Leukemia (AML), Refractory Acute Myeloid Leukemia (AML), Relapsed/Refractory AML, Relapsed Myelodysplastic Syndromes
- Trial name
- NCT06846606
- Testing
- AUTX-703
- Where
- 9 sites in United States
- Volunteers
- 69 people
- Sponsor
- Auron Therapeutics, Inc.
Leukemia, Myeloid
A Safety, Tolerability and Preliminary Efficacy Study of CC-90011 in Combination With Venetoclax and Azacitidine in R/R Acute Myeloid Leukemia and Treatment-naïve Participants Not Eligible for Intensive Therapy
CC-90011-AML-002 is a Phase 1/2, open-label, multicenter study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently with Venetoclax and Azacitidine.
- Trial name
- NCT04748848
- Testing
- CC-90011, Venetoclax, Azacitidine
- Where
- 17 sites in United States, Belgium and 2 more
- Volunteers
- 1 people
- Sponsor
- Celgene
Acute Myeloid Leukemia, Myeloproliferative Neoplasm
A Study of TAS1553 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) and Other Myeloid Neoplasms
This is a Phase 1, 2-part, open-label, multicenter, first-in-human (FIH) study to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of TAS1553 administered orally to participants…
- Conditions
- Acute Myeloid Leukemia, Myeloproliferative Neoplasm, Myelodysplastic/Myeloproliferative Neoplasm
- Trial name
- NCT04637009
- Testing
- TAS1553
- Where
- 10 sites in United States, Canada
- Volunteers
- 20 people
- Sponsor
- Astex Pharmaceuticals, Inc.
Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Ia: To observe the safety and tolerability of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of BL-M11D1.
- Trial name
- NCT05924750
- Testing
- BL-M11D1
- Where
- 8 sites in China
- Volunteers
- 130 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Myelodysplastic Syndromes, Acute Myeloid Leukemia
A Study of Sabatolimab and Magrolimab-based Treatment in AML or Higher Risk MDS Participants
This study is to determine the safety and preliminary efficacy of sabatolimab in combination with magrolimab and azacitidine in adult participants with 1L unfit Acute Myeloid Leukemia (AML) or with 1L higher risk Myelodysplastic…
- Trial name
- NCT05367401
- Testing
- Sabatolimab, Magrolimab, Azacitidine
- Sponsor
- Novartis Pharmaceuticals
Acute Myeloid Leukemia, B-cell Non-Hodgkin Lymphoma
PRT1419 as Monotherapy or in Combination With Azacitidine or Venetoclax in R/R Myeloid or B-cell Malignancies
This is a Phase 1 dose-escalation study of PRT1419, a myeloid cell leukemia-1 (MCL-1) inhibitor, in participants with selected relapsed/refractory myeloid or B-cell malignancies.
- Conditions
- Acute Myeloid Leukemia, B-cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Chronic Myelomonocytic Leukemia
- Trial name
- NCT05107856
- Testing
- PRT1419, Azacitidine, Venetoclax
- Where
- 9 sites in United States
- Volunteers
- 21 people
- Sponsor
- Prelude Therapeutics Incorporated