HV-101 for Patients With Advanced Solid Tumors
Summary
Background: Tumor-infiltrating lymphocyte (TIL) therapy is a type of adoptive cellular therapy by harvesting infiltrated lymphocytes from tumors, culturing and amplifying them in vitro and then infusing back to treat patients. TIL therapy has shown strong efficacy for the treatment of solid tumors, and has achieved high objective response rates in multiple cancers. Objective: To evaluate the safety and efficacy of HV-101 for the treatment of advanced solid tumors. Eligibility: Adults aging 18-75 with advanced solid tumors Design: 1. Patients will undergo screening tests, including imaging procedures, heart and lung tests, and lab tests. 2. Freshly resected patient tumors were dissected by the surgeon. 3. TIL cells were isolated from the patient's tumor tissue in the laboratory, then cultured in vitro, activated and expanded. 4. HV-101 will be re-infused into the patient.
Timeline
- Start
- 2023-08-04
- Primary completion
- 2025-05-31
- Completion
- 2026-01-15
Outcome
Outcome not reported
Stopped (Business): “Portfolio prioritization”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HV-101 | Cell therapy | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |
| Background | IL-2 | Protein / enzyme biologic | — | Intravenous |