Clinical Trial

Sequential CAR-T Cells Therapy for CD5/CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5/CD7-Specific CAR-T Cells

Study acronym: BAH246
Recruiting Phase 1/2
View on ClinicalTrials.gov →
Record status
This record was last updated November 12, 2024 (before its estimated December 10, 2025 completion). Its status may not reflect the trial's current state.
Summary
Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30,BCMA,CD123, etc. may be the potential to develop the corresponding CAR-T cells to treat patients whose tumors express those markers. In this study, investigators will evaluate the safety and efficacy of Sequential CAR-T Cells Targeting CD5/CD7 in patients with patients with relapsed or refractory T-ALL/LBL/ETP-ALL. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, disease status after treatment will also be evaluated.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-05-14; most recent amendment 2024-11-10.
Status change: Not Yet Recruiting → Recruiting 2024-07-29
Trial Details
NCT Number NCT06420076
Lead Sponsor Essen Biotech
Conditions T Cell Lymphoma, T Cell Leukemia, T-cell Acute Lymphoblastic Leukemia, T-Cell Lymphoma of CNS, T Cell Prolymphocytic Leukemia, T Cell Childhood ALL
Enrollment 60 participants
Start Date 2024-07-10
Primary Completion 2025-12-10 (estimated)
Study Completion 2026-12-28 (estimated)
Updated on ClinicalTrials.gov 2024-11-12