Clinical trials: R/R AML, open to volunteers
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
Acute Myeloid Leukemia (AML)
Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML
Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with eligible genetic alterations.
- Trial name
- NCT07007312
- Testing
- Ziftomenib, Venetoclax, Azacitidine (AZA)
- Where
- 136 sites in United States, Australia and 15 more
- Volunteers
- 1,300 people
- Sponsor
- Kura Oncology, Inc.
Acute Myeloid Leukemia, Mixed Lineage Leukemia Gene Mutation
A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML
Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with certain genetic alterations.
- Conditions
- Acute Myeloid Leukemia, Mixed Lineage Leukemia Gene Mutation, Refractory AML, AML With Mutated NPM1
- Trial name
- NCT05735184
- Testing
- Ziftomenib, Venetoclax, Azacitidine
- Where
- 44 sites in United States
- Volunteers
- 420 people
- Sponsor
- Kura Oncology, Inc.
Leukemia, Leukemia, Myeloid
A Study of BH-30236 in Relapsed/ Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome
Study BH-30236-01 is a first-in-human (FIH), Phase 1/1b, open-label, dose escalation and expansion study in participants with relapsed/refractory acute myelogenous leukemia (R/R AML) or higher-risk myelodysplastic syndrome…
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Preleukemia
- Trial name
- NCT06501196
- Testing
- BH-30236, Venetoclax
- Where
- 13 sites in United States
- Volunteers
- 170 people
- Sponsor
- BlossomHill Therapeutics
R/R AML, R/R HR-MDS
First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)
The drug that will be investigated in the trial is an antibody, GEN3018. Since this is the first trial of GEN3018 in humans, the main purpose is to evaluate safety.
- Conditions
- R/R AML, R/R HR-MDS, Acute Myeloid Leukemia, Higher-Risk Myelodysplastic Syndrome
- Trial name
- NCT07384715
- Testing
- GEN3018
- Where
- 9 sites in Denmark, Italy and 1 more
- Volunteers
- 78 people
- Sponsor
- Genmab
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.
Acute Myeloid Leukemia (AML)
Induced Pluripotent Stem Cells Derived Natural Killer Cells Therapy for Refractory and Relaps Acute Myelogenous Leukemia
This is a clinical study on the use of iNK cells for the treatment of refractory relapsed acute myeloid leukemia.
- Trial name
- iNK-r/r AML (NCT06702098)
- Testing
- iNK cells
- Where
- China
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Guangzhou Ruixin Biotechnological Co., LTD
AML, NHL
A Phase 1 Study of FD-001 in Recurrent /Refractory (R/R)AML/NHL/MM/MDS
This is a single-arm, open-label, dose-escalation and dose-expansion phase I clinical trial aimed at assessing the safety, tolerability, pharmacokinetic/pharmacodynamic profile, and preliminary efficacy of FD-001 capsules in the…
- Trial name
- NCT06731699
- Testing
- FD-001
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Chengdu FenDi Pharmaceutical Co., Ltd.
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.
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
A Study to Evaluate HMPL-306 in Patients With IDH1or IDH2-mutated Acute Myeloid Leukemia
This study is a multicenter, randomized, open-label, phase III clinical study (RAPHAEL) to evaluate the efficacy, safety, and PK of HMPL-306 versus salvage chemotherapy in patients with R/R AML harboring IDH1 and IDH2 mutations.
- Trial name
- NCT06387069
- Testing
- HMPL-306 Regimen, Salvage Chemotherapy Regimen
- Where
- 53 sites in China
- Volunteers
- 316 people
- Sponsor
- Hutchmed
Relapsed Adult AML
Study of Oral PCLX-001 in R/R Acute Myeloid Leukemia
This is a dose-finding study of oral zelenirstat (PCLX-001) in patients with R/R AML. There are two parts to the study: Dose Escalation and Dose Expansion.
- Trial name
- NCT06613217
- Testing
- zelenirstat
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Pacylex Pharmaceuticals
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
The primary purpose of this study is to characterize the pharmacokinetic (PK) parameters of revumenib and its major metabolite, N-deethyl revumenib (M1) after a single dose of revumenib in participants with severe liver or kidney…
- Conditions
- Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia, Refractory Leukemia, Relapsed Leukemia
- Trial name
- NCT07923071
- Testing
- Revumenib
- Volunteers
- 18 people
- Sponsor
- Syndax Pharmaceuticals
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
The goal of this clinical trial is to learn if sonrotoclax (BGB-11417) is safe and may help treat children and adolescents with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that has come back after treatment…
- Conditions
- Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia, Pediatric Cancer
- Trial name
- NCT07770698
- Testing
- sonrotoclax, Azacitidine, Inotuzumab ozogamicin
- Volunteers
- 30 people
- Sponsor
- BeOne Medicines
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.
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.
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
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
Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
Clinical Study of Anti-FLT3 CAR-T Cells for the Treatment of Relapsed/Refractory AML
This is a phase 1 dose escalation study to determine the safety of anti-FLT3 CAR-T in subjects with R/R AML. The primary objective is to assess safety.
- Trial name
- NCT06786533
- Testing
- Anti-FLT3 CAR-T cells
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Hemogenyx Pharmaceuticals LLC
Leukemia, Acute Myeloid (AML)
HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML
A randomized，multicenter, open-label Phase III, clinical study is conducted to evaluate the clinical benefit Clifutinib in Chinese patients with relapsed/ refractory (R/R) FLT3-mutated AML as shown with overall survival compared…
- Trial name
- NCT05586074
- Testing
- Clifutinib, LoDAC, Azacitidine
- Where
- China
- Volunteers
- 324 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.