Clinical trials: AML/MDS
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
AML, Adult, MDS
Eganelisib as Monotherapy and in Combination With Cytarabine in Relapsed/Refractory AML/HR-MDS and in Combination With Azacitidine in Previously Untreated HR-MDS
This is a Phase 1b open-label, multicenter, dose-escalation and randomized combination cohort study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor efficacy of…
- Trial name
- NCT06533761
- Testing
- Eganelisib, Eganelisib in combination with cytarabine, Eganelisib in combination with azacitidine
- Where
- 12 sites in United States, Spain
- Volunteers
- 105 people
- Sponsor
- Stelexis BioSciences
AML (Acute Myelogenous Leukemia), MDS (Myelodysplastic Syndrome)
Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML/MDS Patients (FORWARD)
AlloHeme is a blood-based monitoring test developed by the CareDx laboratory that utilizes NGS technology coupled with a proprietary algorithm to predict the likelihood of a relapse in post-allo-HCT AML/MDS patients.
- Conditions
- AML (Acute Myelogenous Leukemia), MDS (Myelodysplastic Syndrome), CMML
- Trial name
- FORWARD (NCT07607327)
- Testing
- AlloHeme
- Where
- 3 sites in United States
- Volunteers
- 400 people
- Sponsor
- CareDx
AML, MDS
A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA)
This is a multi-center, non-randomized, concurrent controlled, multi-arm, Phase 1 interventional, open-label, biologic assignment-based umbrella study evaluating the feasibility, safety and preliminary efficacy of an escalating…
- Trial name
- NCT05473910
- Testing
- SOC + TSC-101, Control, SOC + TSC-100
- Where
- 21 sites in United States
- Volunteers
- 310 people
- Sponsor
- TScan Therapeutics, Inc.
AML, MDS
A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation
This is a multicenter, genetically-randomized, controlled, Phase 3 study evaluating the efficacy and safety of T-cell receptor-engineered donor T cells targeting HA-2 (TSC-101) administered following reduced-intensity…
- Trial name
- ALLOHA-2 (NCT07702578)
- Testing
- TSC-101, Control
- Where
- 26 sites in United States
- Volunteers
- 310 people
- Sponsor
- TScan Therapeutics, Inc.
Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation
Phase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant malignancies
- Conditions
- Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Carcinoma, Pancreatic Adenocarcinoma
- Trial name
- NCT05877599
- Testing
- NT-175
- Where
- 20 sites in United States
- Volunteers
- 45 people
- Sponsor
- AstraZeneca
MYELODYSPLASTIC SYNDROME; MDS, ACUTE MYELOID LEUKEMIA; AML
JSP191 Antibody Conditioning Regimen in MDS/AML Subjects Undergoing Allogenic Hematopoietic Stem Cell Transplantation
This is a Phase 1a/b study to evaluate the safety and tolerability of an antibody conditioning regimen known as JSP191, in combination with low dose radiation and fludarabine, in subjects with Myelodysplastic Syndrome (MDS) or…
- Trial name
- NCT04429191
- Testing
- Humanized anti-CD117 Monoclonal Antibody (JSP191)
- Where
- 6 sites in United States
- Volunteers
- 32 people
- Sponsor
- Jasper Therapeutics, Inc.
AML, Adult Recurrent, ALL, Recurrent, Adult
BSB-1001 in Patients Undergoing HLA-Matched Allogenic Hematopoietic Stem Cell Transplant for AML, ALL or MDS
The goal of this clinical trial is to test BSB-1001 which is a new type of cellular therapy to treat blood cancers (AML, ALL and MDS).
- Conditions
- AML, Adult Recurrent, ALL, Recurrent, Adult, MDS
- Trial name
- NCT06704152
- Testing
- SOC + BSB-1001 Dose Escalation Cohort, SOC+BSB-1001 Expansion Dose
- Where
- 6 sites in United States
- Volunteers
- 2 people
- Sponsor
- BlueSphere Bio, Inc
Acute Myeloid Leukemia (AML), MDS (Myelodysplastic Syndrome)
PBSS1113 in Combination With Azacitidine to Treat Patients With AML/MDS
Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) are highly heterogeneous myeloid malignancies where few effective targeted therapies are available.
- Trial name
- NCT07761533
- Testing
- PBSS1113
- Where
- China
- Volunteers
- 29 people
- Sponsor
- Chaser Therapeutics, Inc.
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), 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), Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases
Caris Chromoseq Data Collection
The study will collect clinical data on patients who receive the Caris Chromoseq assay for an underlying hematologic malignancy.
- Conditions
- Acute Myeloid Leukemia (AML), Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases, Myelodysplatic Syndromes, Myeloproliferative Neoplasm
- Trial name
- NCT07680868
- Testing
- Caris Chromoseq
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Caris Science, Inc.
Acute Myeloid Leukaemia (AML), Myelodysplastic Syndrome (MDS)
Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics
This study aim is to assess, if treosulfan pharmacokinetics are influenced by declined renal function and by race/ethnicity of patients.
- Conditions
- Acute Myeloid Leukaemia (AML), Myelodysplastic Syndrome (MDS), Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
- Trial name
- NCT05534620
- Testing
- Treosulfan, Fludarabine
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- medac GmbH
AML, Adult Recurrent, MDS
A Phase 1 Study With LYT-200 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML), or With Relapsed/Refractory, High-risk Myelodysplastic Syndrome (MDS)
A Phase 1 Open-label, Multi-center Study of the Safety, Pharmacokinetics (PK), and Anti-tumor Activity of LYT- 200 in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AML), or with Relapsed/refractory, High-risk…
- Trial name
- NCT05829226
- Testing
- LYT-200, Venetoclax, Azacitidine
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- PureTech
Cancer, MDS-EB
A Phase I Open-Label Dose Escalation Study of Intravenous INKmune In Patients With MDS or AML
INMB-INB16-002 is a Phase I open-label, dose escalation study of INKmune therapy in subjects with myelodysplastic syndrome (MDS) with excess blasts without Auer rods (EB-1 or 2, or CMML 1 or 2) or subjects with acute myeloid…
- Conditions
- Cancer, MDS-EB, Myelodysplastic Syndromes, Acute Myeloid Leukemia
- Trial name
- LAUREL (NCT05933070)
- Testing
- INKmune
- Where
- 3 sites in Greece, United Kingdom
- Volunteers
- 2 people
- Sponsor
- Inmune Bio, Inc.
Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)/AML
A Study to Evaluate S227928 as a Single Agent and in Combination With Venetoclax in Patients With R/R AML, MDS/AML, or CMML
The objective of this study is to determine the safety, tolerability, and anti-leukemic activity of S227928 as single agent and in combination with venetoclax, and to determine the recommended Phase 2 dose (RP2D) of this…
- Conditions
- Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)/AML, Chronic Myelomonocytic Leukemia (CMML)
- Trial name
- NCT06563804
- Testing
- S227928, Venetoclax
- Where
- 16 sites in United States, Australia and 4 more
- Volunteers
- 13 people
- Sponsor
- Servier Bio-Innovation LLC
Hematological Malignancies, Acute Lymphoblastic Leukemia (ALL)
Stem Cell Transplantation With NiCord® (Omidubicel) vs Standard UCB in Patients With Leukemia, Lymphoma, and MDS
This study is an open-label, controlled, multicenter, international, Phase III, randomized study of transplantation of NiCord® versus transplantation of one or two unmanipulated, unrelated cord blood units in patients with acute…
- Conditions
- Hematological Malignancies, Acute Lymphoblastic Leukemia (ALL), Acute Myelogenous Leukemia (AML), Chronic Myelogenous Leukemia (CML)
- Trial name
- NCT02730299
- Testing
- NiCord® (omidubicel), Cord Blood Unit
- Where
- 52 sites in United States, Brazil and 8 more
- Volunteers
- 125 people
- Sponsor
- Gamida Cell ltd
AML/MDS, CD33 Expressing Hematological Malignancies
SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Cancers Including AML/MDS
This is an open-label study of the safety, biodynamics, and anti-cancer activity of SENTI-202 (an off-the-shelf logic gated CAR NK cell therapy) in patients with CD33 and/or FLT3 expressing blood cancers, including AML and MDS.
- Conditions
- AML/MDS, CD33 Expressing Hematological Malignancies, FLT3 Expressing Hematological Malignancies
- Trial name
- NCT06325748
- Testing
- SENTI-202
- Where
- 8 sites in United States, Australia
- Volunteers
- 21 people
- Sponsor
- Senti Biosciences
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
AML/MDS, CMML
Dose-Escalation Study of Oral Administration of LP-108 as Monotherapy and in Combination With Azacitidine in Patients With Relapsed or Refractory MDS, CMML, or AML
A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Clinical Activity of Orally Administered LP-108 as Monotherapy and in Combination with Azacitidine in Subjects with…
- Conditions
- AML/MDS, CMML, Relapse, Refractory Acute Lymphoblastic Leukemia
- Trial name
- NCT04139434
- Testing
- LP-108, LP-108 and azacitidine
- Where
- 7 sites in United States, Spain
- Volunteers
- 32 people
- Sponsor
- Newave Pharmaceutical Inc