Anti-CD33-CLL1 CAR-T Cells (ICG415) for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
NCT07668557 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2026-06-25
Summary
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). Subjects receive lymphodepleting chemotherapy followed by autologous CAR-T infusion. The primary goal is to assess safety and preliminary anti-leukemic efficacy in patients failing standard AML therapies.
Conditions
- Acute Myeloid Leukemia (AML)
Interventions
- BIOLOGICAL
-
Anti-CD33-CLL1 CAR-T cells (ICG415) following lymphodepleting fludarabine and cyclophosphamide
Anti-CD33, Anti-CLL1 Compound CAR-T Cells
Sponsors & Collaborators
-
iCell Gene Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-10
- Primary Completion
- 2028-07-04
- Completion
- 2029-07-04
Countries
- China
Study Locations
More Related Trials
-
CAR-T Cells Therapy in Relapsed/Refractory Acute Myeloid Leukemia
NCT03473457 ·Status: TERMINATED ·Phase: NA
-
Phase I/II Study of Enhanced CD33 CAR T Cells in Subjects With Relapsed or Refractory Acute Myeloid Leukemia
NCT04835519 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Clinical Study of Novel CAR-ITNK Cells Targeting CD70 and CLL1 for Refractory/Relapsed AML
NCT07336875 ·Status: NOT_YET_RECRUITING ·Phase: EARLY_PHASE1
-
Exploratory Clinical Study on the Safety and Efficacy of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Myeloid Malignancies
NCT06917105 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
NCT06871410 ·Status: RECRUITING ·Phase: PHASE1
-
Donor-derived CAR-T Cells in the Treatment of AML Patients
NCT04766840 ·Status: UNKNOWN ·Phase: PHASE1
-
A Clinical Study to Explore the Safety and Efficacy of CD33 CAR-T Cell in Relapsed/Refractory Acute Myeloid Leukemia
NCT06762132 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
A Clinical Study of CAR-T Treating Relapsed or Refractory T Cell Lymphoblastic Acute Leukemia/ Lymphoma
NCT05909527 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Evaluate the Safety and Efficacy of CD33 CAR-T in Patients With R/R AML
NCT05473221 ·Status: UNKNOWN ·Phase: PHASE1
-
CLL-1 CAR-NK Cells for Relapsed/Refractory AML
NCT06307054 ·Status: RECRUITING ·Phase: PHASE1
-
CD123-CD33 cCAR in Patients With Relapsed and/or Refractory, High Risk Hematologic Malignancies
NCT04156256 ·Status: UNKNOWN ·Phase: EARLY_PHASE1
-
Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Malignancies
NCT06316427 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies
NCT05528887 ·Status: RECRUITING ·Phase: PHASE1
-
A Multicenter, Open-label, Non-randomized, Single-arm Phase 1/2 Study of Autologous Nano CD5-CAR T Cells for the Treatment of Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia/Lymphoma
NCT07678307 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1/PHASE2
-
CLL1-CD33 cCAR in Patients With Relapsed and/or Refractory, High Risk Hematologic Malignancies
NCT03795779 ·Status: UNKNOWN ·Phase: EARLY_PHASE1
-
Study of Anti-CD33/CLL1 CAR-NK in Acute Myeloid Leukemia
NCT05215015 ·Status: UNKNOWN ·Phase: EARLY_PHASE1
-
Dual CD33-CLL1-CAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
NCT05016063 ·Status: UNKNOWN ·Phase: EARLY_PHASE1
-
A Study of CAR T-Cells in Relapsed/Refractory Hematologic Malignancy
NCT06756321 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
A Clinical Study to Evaluate the Safety and Efficacy of CLL1 and CD38 Dual-Target CAR-T Cell Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
NCT06880354 ·Status: RECRUITING ·Phase: PHASE1
-
CD5 Chimeric Antigen Receptor (CAR) T Cells in Subjects With Relapsed or Refractory T-cell Malignancies
NCT06316856 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Functionally Optimized CD33 CAR-T Cell Therapy Targeting Recurrent/Refractory Acute Myeloid Leukemia
NCT07538713 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Clinical Study on the Safety, Efficacy and Pharmacokinetics of Universal CLL1 Chimeric Antigen Receptor T-Cell in Relapsed/Refractory Acute Myeloid Leukemia
NCT07432100 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Safety and Efficacy of CLL1 CAR-T Followed by Allogeneic Hematopoietic Stem Cell Transplantation in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
NCT07342244 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
CD7 CAR-T Cell Treatment of Relapsed/Refractory CD7+ T -Acute Lymphoblastic Leukemia/ Lymphoma
NCT05212584 ·Status: UNKNOWN ·Phase: PHASE1
-
Safety and Efficacy of CD123-Targeted CAR-T Therapy for Relapsed/Refractory Acute Myeloid Leukemia
NCT04272125 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2