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CLDN6 CAR-T · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1 - CLDN6 CAR-T | EXPERIMENTAL | Dose escalation in lymphodepleted patients until the MTD and/or RP2D. |
| Part 2 Vaccine-modulated - CLDN6 uRNA-LPX/CLDN6 modRNA-LPX | EXPERIMENTAL | Dose escalation until the MTD and/or RP2D. |
| Name | Type | Description |
|---|---|---|
| CLDN6 CAR-T | BIOLOGICAL | administered as an intravenous (i.v.) infusion. |
| CLDN6 uRNA-LPX/CLDN6 modRNA-LPX | BIOLOGICAL | administered as an i.v. injection at protocol-specified intervals. |
Inclusion Criteria: * Each patient enrolled in the trial must have CLDN6-positive tumor regardless of tumor histology defined as ≥ 50% of tumor cells expressing CLDN6 protein at an intensity of ≥2+ using a semi-quantitative immunohistochemistry assay in a central laboratory for specific detection o...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
CLDN6 CAR-T is an investigational cell therapy being studied for the treatment of solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The therapy is being evaluated in a clinical trial that also tests an investigational RNA-based vaccine, given with and without the vaccine, in patients with organ tumors.
CLDN6 CAR-T is a chimeric antigen receptor T-cell therapy designed to target CLDN6, a protein expressed on certain solid tumors. The therapy is being developed to direct a patient's own T cells to recognize and attack cancer cells that display this target. This mechanism is being investigated in a Phase 1 clinical trial.
CLDN6 CAR-T is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting a Phase 1 clinical trial of the therapy in patients with solid tumors, with study sites in Australia, Germany, Netherlands, and Sweden.
CLDN6 CAR-T is in Phase 1 clinical development. It is an investigational therapy that has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is active but not recruiting participants, and it is designed to evaluate the safety and effectiveness of the therapy in patients with solid tumors.
CLDN6 CAR-T is being studied in one active Phase 1 clinical trial with the identifier NCT04503278. The trial is titled 'A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors' and has a planned enrollment of 214 participants.
CLDN6 CAR-T is a type of chimeric antigen receptor T-cell therapy, commonly referred to as CAR-T. It is an investigational cell therapy being developed by BioNTech SE for solid tumors. The therapy is currently in Phase 1 clinical trials and is not yet approved for commercial use.