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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05483491 | KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer | PHASE1 | RECRUITING | 30 | — | — | Sep 26, 2022 | Dec 31, 2028 | Mar 30, 2025 | 2 | United States |
The highest dose level achieved according to the protocol-defined criteria for DLTs and determination of MTD.
| Arm | Type | Description |
|---|---|---|
| KK-LC-1 TCR-T cells | EXPERIMENTAL | Subjects will receive a conditioning regimen, KK-LC-1 TCR-T cells, and aldesleukin. |
| Name | Type | Description |
|---|---|---|
| KK-LC-1 TCR-T cells | BIOLOGICAL | Participants will receive a conditioning regimen consisting of cyclophosphamide and fludarabine. KK-LC-1 TCR-T cells will be administered as a single intravenous infusion. |
| Aldesleukin | DRUG | Aldesleukin 720,000 IU/kg IV every 8 hours will be preferentially administered as an inpatient within 24 hours after KK-LC-1 TCR-T cell infusion for up to 6 doses; however up to 24 hours may elapse between doses. Aldesleukin dosing will be stopped for aldesleukin-related grade 3 or greater toxicity other than flushing, fever, chills, or hemodynamic changes (tachycardia or hypotension) that respond to crystalloid infusion. Aldesleukin may also be stopped at any time at investigator discretion. |
1\. Inclusion Criteria: Subjects must meet all the following criteria to participate in this study. 1. Signed, written informed consent obtained prior to any study procedures. 2. Age \> 18 years at the time of informed consent. 3. Metastatic solid tumor with ≥ 10% of tumor cells positive for KK-LC-...