T-Cell Acute Lymphoblastic Leukemia Clinical Trial
Official title:
First-in-Human (FIH), Open-Label, Non-Randomized, Single-Arm Phase 1 Study to Evaluate the Safety and Tolerability of Donor-Derived CD5 CAR T Cells in Subjects With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia
This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and tolerability of CD5 CAR T cells in subjects with relapsed or refractory T-cell acute lymphoblastic leukemia. At least 18 subjects will be enrolled. After the collection of PBMC and about 5 days before infusion, lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day; for prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) will be administrated for 3 days. Then this study will be using BOIN1/2 approach from starting dose 1: 1×10^6 (±20%) to dose 2: 2×10^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10^5 (±20%) /kg.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04033302 -
Multi-CAR T Cell Therapy Targeting CD7-positive Malignancies
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05995028 -
Universal 4SCAR7U Targeting CD7-positive Malignancies
|
Phase 1 | |
| Recruiting |
NCT05596266 -
CD5 CAR-T Therapy for Refractory/Relapsed CD5+ T-cell Acute Lymphoblastic Leukemia
|
Phase 1 | |
| Completed |
NCT01950286 -
Hyper-CVAD Treatment of Adult T-cell Acute Lymphoblastic Leukemia in Sweden.
|
N/A | |
| Completed |
NCT02518113 -
A Study of LY3039478 in Combination With Dexamethasone in Participants With T-ALL/T-LBL
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03081910 -
Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen
|
Phase 1 | |
| Recruiting |
NCT05290155 -
Anti-CD7 CAR-T Cell Therapy for Relapse and Refractory CD7 Positive T Cell Malignancies
|
Phase 1 | |
| Recruiting |
NCT05289687 -
Daratumumab for Chemotherapy-Refractory Minimal Residual Disease in T Cell ALL
|
Phase 2 | |
| Recruiting |
NCT04972942 -
Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in CAYA With High Risk T-Cell ALL & Lymphoma
|
Phase 1 | |
| Not yet recruiting |
NCT06390319 -
Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)
|
Phase 2 | |
| Recruiting |
NCT06316427 -
Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Acute Lymphoblastic Leukemia/Lymphoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05277753 -
NGS-MRD Assessment of Combination Immunotherapies Targeting T-ALL
|
Phase 1 | |
| Recruiting |
NCT05679895 -
Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL
|
Phase 1 | |
| Active, not recruiting |
NCT04984356 -
A Phase 1/2 Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05832125 -
Registry of Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia
|
||
| Withdrawn |
NCT04860817 -
A Study of Anti-CD7 CAR-T Cells in Pediatric and Young Adult Patients With Relapse and Refractory T-ALL/ T-LBL
|
Early Phase 1 | |
| Recruiting |
NCT04934774 -
Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances
|
Phase 1 | |
| Recruiting |
NCT04594135 -
Anti-CD5 CAR T Cells for Relapsed/Refractory T Cell Malignancies
|
Phase 1 | |
| Enrolling by invitation |
NCT05509855 -
A Long-Term Safety Follow-Up Study for Patients Treat With WU-CART-007
|
||
| Recruiting |
NCT05376111 -
Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients
|
Phase 2 |