Trials / Completed
CompletedNCT05628883
Proof of Concept of TBio-4101, Lymphodepleting Chemo, IL-2 for Relapsed/Refractory Melanoma
A Proof of Concept Study of TBio-4101 (an Autologous Selected and Expanded Tumor Infiltrating Lymphocyte [TIL] Therapy) Using Short-Term Cultured, Selected Autologous TIL Following a Lymphodepleting Chemotherapy Regimen and Followed by IL-2 for Patients With Relapsed or Refractory Melanoma (Phase 1)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this first in human study is to evaluate the feasibility, safety, and efficacy of administering TBio-4101 (tumor infiltrating lymphocytes \[TIL\]) after receiving a lymphodepleting chemotherapy regimen and before receiving interleukin-2 (IL-2) in participants with unresectable or metastatic melanoma.
Conditions
- Metastatic Melanoma
- Unresectable Melanoma
- Acral Melanoma
- Mucosal Melanoma
- Cutaneous Melanoma
- Ocular Melanoma
- Uveal Melanoma
- Iris Melanoma
- Conjunctival Melanoma
- Non-Cutaneous Melanoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TBio-4101 | TBio-4101 is a tumor-infiltrating lymphocyte (TIL) product that involves the use of special immune cells called T-cells. A T-cell is a type of lymphocyte, or white blood cell. |
| DRUG | Cyclophosphamide | Participants will receive Cyclophosphamide 60 mg/kg/day intravenously (IV) in 250 mL over approximately 1 hour per day for 2 days. |
| DRUG | Fludarabine | Participants will receive an intravenously (IV) infusion of Fludarabine 25 mg/m2 for approximately 15 to 30 minutes for 5 days, prior to T-Cell infusion |
| DRUG | Interleukin-2 | Participants will receive Interleukin-2 (IL-2) 600 000 IU/kg intravenously every 8 to 12 hours beginning within 24 hours after T-cell infusion. |
Timeline
- Start date
- 2022-11-22
- Primary completion
- 2024-12-03
- Completion
- 2025-03-06
- First posted
- 2022-11-29
- Last updated
- 2026-04-02
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05628883. Inclusion in this directory is not an endorsement.