The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors
Plain-language summary
This Phase 1, Phase 2 trial is testing CAR-T Cells infusion(CAR2219, CAR2019, and other medications for people whose T-cell lymphoma has come back or has not responded to previous treatment. The study starts with lower doses to find the safest effective dose before testing in more people. This trial does not currently list US sites.
Who can join (key eligibility)
- Age 18 Years or older
- Lymphoma came back or did not respond to prior treatment
- Must be well enough for treatment (adequate performance status)
- May require specific number of prior treatments
Final eligibility is determined by the trial team. This list is a starting point only.
What's being tested
CAR-T Cells infusion(CAR2219,CAR2019, CAR19 etc) (DRUG): Phase I study: dose-escalation component.This part follows the "3+3" dose-escalation model, with 5 dose groups: 1×10\^6, 1.5×10\^6, 2×10\^6, 2.5×10\^6, 3×10\^6 CAR+ cells/kg (different target CAR-T can be adjusted by the investigator according to the dose used in the previous clinical trial). Each dose group enrolled 3\~6 patients with relapsed/refractory hematological diseases respectively, totaling 15\~30 subjects, in order to evaluate the safety of CAR-T cells for the treatment of relapsed/refractory malignant hematological neoplasms and to determine the MTD. Phase II study: dose-expansion portion. After the MTD was confirmed, in the dose-expansion portion of the study (Phase II), it was expected that 65\~60 subjects would receive the CAR-T cell injection infusion under RP2D to further evaluate the efficacy of CAR-T cell injection.
- Drugs / treatments
- CAR-T Cells infusion(CAR2219,CAR2019, CAR19 etc)
- Treatment length
- Ask the trial team for details
- Visit frequency
- Ask the trial team for details