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KK-LC-1 TCR-T cells · 1 trial · 4 indications
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. |
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-1 by ...
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KK-LC-1 TCR-T cells is an investigational cell therapy being developed for gastric cancer. It is also being studied in breast, cervical, and lung cancer. The therapy is in Phase 1 clinical development and is not yet approved by the FDA.
KK-LC-1 TCR-T cells is being developed by Iovance Biotherapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker IOVA. The company is conducting a Phase 1 clinical trial for this investigational therapy.
KK-LC-1 TCR-T cells is in Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved by the FDA and is still being studied in clinical trials for safety and efficacy.
KK-LC-1 TCR-T cells is being studied in a Phase 1 clinical trial with the identifier NCT05483491. This trial is recruiting participants with gastric, breast, cervical, and lung cancer in the United States, with an enrollment target of 30 patients.
KK-LC-1 TCR-T cells is not FDA approved. It is an investigational therapy currently in Phase 1 clinical development. The therapy is being studied in a clinical trial for gastric cancer and other solid tumors, but it has not yet received regulatory approval.