Clinical trials: R/R AML
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.
Relapsed/Refractory Acute Myeloid Leukemia
Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML
A Phase III study to evaluate the safety and efficacy of CPI-613® (devimistat) in combination with High Dose Cytarabine and Mitoxantrone in comparison with high dose Cytarabine and Mitoxantrone and control sub-groups: combination…
- Trial name
- NCT03504410
- Testing
- CPI-613 + High Dose Cytarabine and Mitoxantrone, High Dose Cytarabine and Mitoxantrone, Mitoxantrone, Etoposide and Cytarabine
- Where
- 60 sites in United States, Australia and 7 more
- Volunteers
- 200 people
- Sponsor
- Cornerstone Pharmaceuticals
Acute Myeloid Leukaemia
A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Relapsed/Refractory Acute Myeloid Leukemia
This is a single group, Phase 1, single-arm, dose escalation study to determine the candidate dose(s), and evaluate safety, tolerability, and preliminary anti-tumor activity of SAR445419 administered after fludarabine and…
- Trial name
- NCT05712278
- Testing
- SAR445419, fludarabine, cytarabine
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- Sanofi
Relapsed/Refractory AML
Study to Evaluate the Efficacy of Uproleselan in Combination With Chemotherapy in Chinese Patients With R/R AML
This bridging study will evaluate the efficacy of uproleselan, a specific E-selectin antagonist, in combination with chemotherapy to treat Chinese relapsed/refractory AML patients, compared to chemotherapy alone.
- Trial name
- NCT05054543
- Testing
- Uproleselan
- Where
- 2 sites in China
- Volunteers
- 140 people
- Sponsor
- Apollomics 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.
Leukemia, Acute Myeloid Leukemia
A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Max-40279-01 in Combination With Azacitidine (AZA) in Patients With Myelodysplastic Syndrome (MDS) or Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
This study is a phase Ib/II study of Max-40279-01 in combination with Azacitidine (AZA) in patients with Myelodysplastic Syndrome (MDS) or Relapsed/Refractory Acute Myeloid Leukemia (R/R AML).
- Conditions
- Leukemia, Acute Myeloid Leukemia, Relapsed/Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT05061147
- Testing
- MAX-40279-01
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Maxinovel Pty., Ltd.
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
Acute Lymphocytic Leukaemia, Acute Myeloid Leukaemia Refractory
First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological…
- Conditions
- Acute Lymphocytic Leukaemia, Acute Myeloid Leukaemia Refractory, Myelodysplastic Syndromes, Blastic Plasmacytoid Dendritic Cell Neoplasia
- Trial name
- NCT05086315
- Testing
- SAR443579
- Where
- 23 sites in United States, Australia and 3 more
- Volunteers
- 101 people
- Sponsor
- Sanofi
AML
(QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive
The primary objective of the study is to determine whether quizartinib monotherapy prolongs overall survival (OS) compared to salvage chemotherapy in subjects with FMS-like tyrosine kinase 3 - Internal Tandem Duplication…
- Trial name
- NCT02039726
- Testing
- Quizartinib, Salvage Chemotherapy
- Where
- 131 sites in United States, Australia and 17 more
- Volunteers
- 367 people
- Sponsor
- Daiichi Sankyo
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, in Relapse, Acute Myeloid Leukemia Refractory
Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)
Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) with FMS-like tyrosine kinase mutation (FLT3 mut+).
- Trial name
- FRIDA (NCT05546580)
- Testing
- Iadademstat, Gilteritinib Oral Tablet
- Where
- 13 sites in United States
- Volunteers
- 50 people
- Sponsor
- Oryzon Genomics S.A.
Leukemia, Leukemia, Myeloid
Natural Killer Cell (CYNK-001) Infusions in Adults with AML
This study will find the maximum tolerated dose or the maximum planned dose of CYNK-001 which contains natural killer (NK) cells derived from human placental CD34+ cells and culture-expanded.
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute, Neoplasms by Histologic Type
- Trial name
- CYNK001AML01 (NCT04310592)
- Testing
- CYNK-001
- Where
- 10 sites in United States
- Volunteers
- 27 people
- Sponsor
- Celularity Incorporated
Relapsed/Refractory AML, AML, Adult
NKX101, Intravenous Allogeneic CAR NK Cells, in Adults With AML or MDS
This is a single-arm, open-label, multi-center, Phase 1 study to determine safety and tolerability of an experimental therapy called NKX101 (allogeneic CAR NK cells targeting NKG2D ligands) in patients with relapsed/refractory…
- Conditions
- Relapsed/Refractory AML, AML, Adult, MDS, Refractory Myelodysplastic Syndromes
- Trial name
- NCT04623944
- Testing
- NKX101 - CAR NK cell therapy
- Where
- 8 sites in United States
- Volunteers
- 61 people
- Sponsor
- Nkarta, Inc.
Acute Myeloblastic Leukaemia, Leukemia, T-Cell
Safety and Efficacy of GYA01 (CART84) in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) and Acute Lymphoblastic T Leukemia Patients (T-ALL).
This Phase I/IIa clinical study is testing an experimental treatment called GYA01 (CART84) for people with acute myeloid leukemia (AML) or T-cell acute lymphoblastic leukemia (T-ALL) whose disease has come back after treatment…
- Trial name
- NCT07471789
- Testing
- CART84
- Where
- 2 sites in Spain
- Volunteers
- 33 people
- Sponsor
- Gyala Therapeutics
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 (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
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
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations
This is an open-label, multi-center Phase 1 study of LY3410738, an oral, covalent isocitrate dehydrogenase (IDH) inhibitor, in patients with IDH1 and/or IDH2-mutant advanced hematologic malignancies who may have received standard…
- Conditions
- Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Chronic Myelomonocytic Leukemia (CMML), Myeloproliferative Neoplasms (MPNs)
- Trial name
- NCT04603001
- Testing
- LY3410738, Venetoclax, Azacitidine
- Where
- 37 sites in United States, Australia and 10 more
- Volunteers
- 260 people
- Sponsor
- Eli Lilly and Company
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