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A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of CRTE7A2-01 TCR-T Cell for HPV16 Positive Advanced Cervical, Anal, or Head and Neck Cancers
A single center, open, single arm dose escalation phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cell for HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine MTD of CRTE7A2-01 TCR-T cell injection, as well as investigate RP2D.
Details
| Lead sponsor | Corregene Biotechnology Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 12 |
| Start date | 2022-07-17 |
| Completion | 2024-12 |
Conditions
- Cervical Cancer
- Anal Cancer
- Head and Neck Cancers
Interventions
- Fludarabine + Cyclophosphamide
- Interleukin-2
- CRTE7A2-01 TCR-T Cell
Primary outcomes
- MTD — 28 days
Maximum Tolerated Dose - DLT — 28 days
Dose-limiting toxicity - RP2D — 28 days
Recommended Phase II Dose - Incidence of treatment related AEs, AEs of special interest and serious adverse events (SAEs). — 2 years
grade 1-5 (CTCAE)
Countries
China