Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06911710 | The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors | PHASE1 | RECRUITING | 90 | — | — | Nov 9, 2024 | Feb 28, 2027 | Apr 4, 2025 | 1 | China |
| Arm | Type | Description |
|---|---|---|
| CAR-T treatment group | EXPERIMENTAL | CAR-T Cells infusion（CAR 2219，CAR2019，CAR19 ect） |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: With their own consent and have signed an informed consent form, willing and able to comply with the planned visits, study treatment, laboratory tests and other experimental procedures; Patients with recurrent/refractory malignant hematologic tumors as determined by clinical dia...