Multi-centers, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Donor-Derived CD7 CAR T Cells in Subjects With Relapsed or Refractory T-cell Leukemia/Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

April 3, 2024

Study Completion Date

April 3, 2024

Conditions
T-cell Leukemia/LymphomaRefractory T Lymphoblastic Leukemia/LymphomaRelapse/Recurrence
Interventions
BIOLOGICAL

chimeric antigen receptor T cell treatment

CD7 CAR T cells will be given once intravenously at one dose (1×106, with an allowance of ± 20%) in patients received previous HSCT donor-derived CAR T cells. Patients who received fresh donor derived CD7 CAR T cells were given initial dose of 1×106, with an allowance of ± 20%. The dose levels may be adjusted during the study based on the specific number of cells on the day of fresh CAR T cells infusion, due to at this time all the patients have completed lymphodepleting, so we adopt the allowance of ±20% for each group of absolute infusion cells. And patients who were lower than the designed dose group were also given infusion, but they will be either assigned to the lower dose group or exclude from safety analysis of designed dose group.

Trial Locations (1)

100000

Beijing Boren Hospital, Beijing

All Listed Sponsors
lead

Beijing Boren Hospital

OTHER

NCT04689659 - Multi-centers, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Donor-Derived CD7 CAR T Cells in Subjects With Relapsed or Refractory T-cell Leukemia/Lymphoma | Biotech Hunter | Biotech Hunter