Clinical trials: CD123+ Acute Myeloid Leukemia
Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL
Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies
Phase 1/2 umbrella study evaluates biomarker-selected dual-target CAR-T cell modules for adults with relapsed or refractory hematologic malignancies.
- Conditions
- Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed/Refractory B-cell Non-Hodgkin Lymphoma or CLL/SLL, Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia, Relapsed/Refractory Acute Myeloid Leukemia, High-risk Myelodysplastic Neoplasm
- Trial name
- ADAPT-HEM (NCT07523555)
- Testing
- Autologous CD19/CD22 dual-target CAR-T module, Autologous CD19/CD20 dual-target CAR-T module, Autologous BCMA/CD19 dual-target CAR-T module
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Beijing Biotech
Acute Myeloid Leukemia
A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
This study will be divided into 2 parts (Part 1 and Part 2). Part 1 will evaluate 2 doses of tagraxofusp (9 and 12 micrograms/kilogram/day [μg/kg/day]), used in combination with venetoclax and azacitidine, to determine the dose…
- Trial name
- TRILLIUM (NCT06456463)
- Testing
- Tagraxofusp, Venetoclax, Azacitidine
- Where
- 32 sites in United States, Australia
- Volunteers
- 85 people
- Sponsor
- Stemline Therapeutics, Inc.
Leukemia, Myeloid, Acute
A Study of CSL362 in Patients With CD123+ Acute Myeloid Leukemia Currently in Remission
This is a first in human, prospective, multicenter, nonrandomized, open-label, dose-escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of repeat doses of CSL362.
- Trial name
- NCT01632852
- Testing
- CSL362
- Where
- 5 sites in United States, Australia
- Volunteers
- 30 people
- Sponsor
- CSL Limited
Leukemia, Leukemia, Myeloid
CD123-Targeted CAR-T Cell Therapy for Relapsed/Refractory Acute Myeloid Leukemia
There are limited options for treatment of relapse/refractory acute myeloid leukemia (AML). CD123 CAR-T cells may have an attractive and permanent effect on anti-tumor.
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute
- Trial name
- NCT04265963
- Testing
- CD123 CAR-T cells
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
AML
Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)
Open-label, multi-dose, single-arm, multi-center, Phase 1/2 study conducted in three segments: the Single Patient Dose Escalation Segment (complete), followed by the Multi-Patient Dose Escalation Segment (complete) and the…
- Trial name
- VOYAGE (NCT02152956)
- Testing
- Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off, Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off, Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
- Where
- 43 sites in United States, France and 6 more
- Volunteers
- 244 people
- Sponsor
- MacroGenics
Acute Myeloid Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Safety and Efficacy of CD123-targeted CAR-NK for Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm
This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of targeting CD123 CAR-NK cell preparations in Relapsed/refractory acute myeloid leukemia (AML)…
- Conditions
- Acute Myeloid Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Relapse Leukemia, Refractory Leukemia
- Trial name
- NCT06006403
- Testing
- CD123 targeted CAR-NK cells
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Acute Myeloid Leukemia
First-in-Human Dose Escalation Study of AFM28 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
This study is a First In Human, phase 1, open-label, non-randomized, multi-center, multiple ascending dose escalation study evaluating AFM28 as a monotherapy in subjects with Relapsed/Refractory CD123-positive Acute Myeloid…
- Trial name
- NCT05817058
- Testing
- AFM28
- Where
- 5 sites in France, Spain
- Volunteers
- 30 people
- Sponsor
- Affimed GmbH
Leukemia, Myeloid, Acute
Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
The purpose of this study is to characterize the safety and tolerability of JNJ-63709178 and identify the recommended Phase 2 dose(s) (RP2D) and schedule for JNJ-63709178 in Part 1 and to characterize the safety and tolerability…
- Trial name
- NCT02715011
- Testing
- JNJ-63709178
- Where
- 10 sites in United States, Spain
- Volunteers
- 62 people
- Sponsor
- Janssen Research & Development, LLC
Acute Myeloid Leukaemia
Phase I Study of UCART123 in Patient With Adverse Genetic Risk Acute Myeloid Leukemia
This is a Phase I, open-label, dose escalation study of UCART123 administered intravenously to patients with newly diagnosed CD123 positive adverse genetic risk acute myeloid leukaemia (AML) defined in the ELN adverse genetic…
- Trial name
- NCT04106076
- Testing
- UCART123
- Sponsor
- Cellectis S.A.
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
Hematologic Malignancy, Acute Myeloid Leukemia
CD123-CD33 cCAR in Patients With Relapsed and/or Refractory, High Risk Hematologic Malignancies
Phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD123-CD33 cCAR in patients with relapsed and/or refractory, high risk hematologic malignancies.
- Conditions
- Hematologic Malignancy, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myeloproliferative Neoplasm
- Trial name
- NCT04156256
- Testing
- CD123-CD33 cCAR T cells
- Where
- 2 sites in China
- Volunteers
- 20 people
- Sponsor
- iCell Gene Therapeutics
Acute Myeloid Leukemia
A Safety Study of SGN-CD123A in Patients With Acute Myeloid Leukemia
The study will examine the safety profile of SGN-CD123A. The study will test increasing doses of SGN-CD123A given every 3 weeks to patients.
- Trial name
- NCT02848248
- Testing
- SGN-CD123A
- Where
- 7 sites in United States
- Volunteers
- 17 people
- Sponsor
- Seagen Inc.
Leukemia, Leukemia, Myeloid
Safety and Efficacy of CD123-Targeted CAR-T Therapy for Relapsed/Refractory Acute Myeloid Leukemia
This is a single arm study to evaluate the efficacy and safety of CD123-targeted CAR-T cells therapy for patients with relapsed/refractory Acute Myeloid Leukemia.
- Conditions
- Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute
- Trial name
- NCT04272125
- Testing
- CD123 CAR-T cells
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Acute Myeloid Leukemia
IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia
This is an open-label, multicenter, Phase 1b/2 study to determine the safety and tolerability of IMGN632 and assess the antileukemia activity of IMGN632 when administered in combination with azacitidine and/or venetoclax in…
- Trial name
- NCT04086264
- Testing
- Azacitidine, IMGN632, Venetoclax
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 218 people
- Sponsor
- AbbVie
Leukemia, Acute Myeloid, Myelodysplastic Syndromes
A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies
CP-MGD024-01 is a Phase 1, open-label, multi-center study of MGD024 as a single agent in participants with select blood cancers that have not responded to treatment with standard therapies or who have relapsed after treatment.
- Conditions
- Leukemia, Acute Myeloid, Myelodysplastic Syndromes, Classical Hodgkin Lymphoma, Leukemia, B-cell
- Trial name
- NCT05362773
- Testing
- MGD024
- Where
- 7 sites in United States
- Volunteers
- 130 people
- Sponsor
- MacroGenics
Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
Study to Evaluate the Safety and Clinical Activity of UCART123 in Patients With BPDCN
A Phase 1 dose-finding study of Universal Chimeric Antigen Receptor T-cells targeting cluster of differentiation (CD) 123 (UCART123) administered intravenously to patients with relapsed or refractory Blastic Plasmacytoid…
- Trial name
- ABC123 (NCT03203369)
- Testing
- UCART123
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Cellectis S.A.
Acute Myeloid Leukemia (AML)
Phase 1 Study of UniCAR02-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies
This dose-escalating phase I trial assesses for the first time the safety, the side effects and the harmlessness, as well as the therapeutical benefit of the new study drug UniCAR02-T-CD123 in patients with hematologic and…
- Trial name
- NCT04230265
- Testing
- Cyclophosphamide (Non-IMP), Fludarabine (Non-IMP), TM123 (IMP)
- Where
- 10 sites in Germany, Netherlands
- Volunteers
- 32 people
- Sponsor
- AvenCell Europe GmbH
Leukemia, Myeloid, Acute
An Efficacy and Safety Study of Decitabine (DACOGEN) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus Decitabine (DACOGEN) Alone in Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy
The primary objective of study Part A is to assess the safety of talacotuzumab (formerly CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with acute myeloid leukemia (AML) for whom experimental…
- Trial name
- NCT02472145
- Testing
- Decitabine 20 mg/m^2, Talacotuzumab 9 mg/kg
- Where
- 81 sites in United States, Australia and 12 more
- Volunteers
- 326 people
- Sponsor
- Janssen Research & Development, LLC
Acute Myelogenous Leukemia, B-cell Acute Lymphoblastic Leukemia
PH 1 Study to Evaluate Safety and Tolerability of XmAb14045 in Patients With CD123-expressing Hematologic Malignancies
The purpose of this study is to determine the safety and tolerability of weekly intravenous (IV) administration of XmAb14045 and to determine the maximally tolerated dose (MTD) after the first dose, and then to determine the MTD…
- Conditions
- Acute Myelogenous Leukemia, B-cell Acute Lymphoblastic Leukemia, Blastic Plasmacytoid Dendritic Cell Neoplasm, Chronic Myeloid Leukemia, Blast Crisis
- Trial name
- NCT02730312
- Testing
- XmAb14045
- Where
- 9 sites in United States
- Volunteers
- 120 people
- Sponsor
- Xencor, Inc.
Acute Myelocytic Leukemia
Study Evaluating Safety and Efficacy of CAR-T Cells Targeting CD123 in Patients With Acute Myelocytic Leukemia
This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting CD123 in the treatment of Acute Myelocytic Leukemia.
- Trial name
- NCT03796390
- Testing
- CD123 CAR-T cells
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Hebei Senlang Biotechnology Inc., Ltd.