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Also known as CLDN6 CAR-T
BNT211 · 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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
BNT211 is an investigational cell therapy being studied in adults with solid tumors. It is being developed for oncology indications and is not yet approved for any use. The Phase 1 study enrolls patients 18 years and older with organ tumors.
BNT211 targets CLDN6, a protein expressed on certain solid tumors. The therapy is a CAR-T product directed at CLDN6, and the trial also evaluates it given with and without an investigational RNA-based vaccine that targets the same protein.
BNT211 is being developed by BioNTech SE, which trades on Nasdaq under the ticker BNTX. BioNTech is the sponsor of the Phase 1 clinical study evaluating the therapy in patients with solid tumors.
BNT211 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The single Phase 1 trial is currently active and not recruiting, with a planned enrollment of 214 patients.
BNT211 is being evaluated in one clinical trial, NCT04503278, titled a 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. The trial is active but not recruiting and is conducted in Australia, Germany, the Netherlands, and Sweden.
Yes, BNT211 is also known as CLDN6 CAR-T and as CLDN6 uRNA-LPX/CLDN6 modRNA-LPX. These names refer to the same BioNTech investigational therapy, which combines a CLDN6-directed CAR-T cell product with an RNA-based vaccine component.