BNT211-01
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
- NCT04503278 ↗
- Active, not recruiting
- BioNTech Cell & Gene Therapies GmbH
- Focused
We haven't built an HCP commentary report on BNT211-01 (CLDN6 CAR-T plus CLDN6 RNA-LPX; CLDN6 CAR-T in CLDN6-positive relapsed or refractory advanced solid tumors) yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on BNT211-01 so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 5 |
The trial
ClinicalTrials.gov- Official title
- Phase I/IIa, First-in-human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of CLDN6 CAR-T With or Without CLDN6 RNA-LPX in Patients With CLDN6-positive Relapsed or Refractory Advanced Solid Tumors
- Phase
- Phase 1
- Status
- Active, not recruiting
- Conditions
- Solid Tumor
- Interventions
- CLDN6 CAR-T; CLDN6 uRNA-LPX/CLDN6 modRNA-LPX
- Arms
- Part 1 - CLDN6 CAR-T · Experimental
- Part 2 Vaccine-modulated - CLDN6 uRNA-LPX/CLDN6 modRNA-LPX · Experimental
- Enrollment
- 214 (estimated)
- Primary outcomes
- Occurrence of treatment-emergent adverse events (TEAEs) including ≥ Grade 3, serious, fatal TEAEs by relationship
- Occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAEs
- Occurrence of dose-limiting toxicity (DLT) during the DLT evaluation period
- Sponsor
- BioNTech Cell & Gene Therapies GmbH
- Start
- Sep 16, 2020
- Primary completion
- Aug 2028 (estimated)
- Results posted
- No
- Registry record
- NCT04503278 · updated Jun 18, 2026
Publications
linked from the registry- Mackensen A, Haanen JBAG, Koenecke C, Alsdorf W, Wagner-Drouet E, Borchmann P, Heudobler D, Ferstl B, Klobuch S, Bokemeyer C, Desuki A, Luke F, Kutsch N, Muller F, Smit E, Hillemanns P, Karagiannis P, Wiegert E, He Y, Ho T, Kang-Fortner Q, Schlitter AM, Schulz-Eying C, Finlayson A, Flemmig C, Kuhlcke K, Preussner L, Rengstl B, Tureci O, Sahin U. CLDN6-specific CAR-T cells plus amplifying RNA vaccine in relapsed or refractory solid tumors: the phase 1 BNT211-01 trial. Nat Med. 2023 Nov;29(11):2844-2853. doi: 10.1038/s41591-023-02612-0. Epub 2023 Oct 23. PubMed 37872225
- Simon AG, Lyu SI, Laible M, Woll S, Tureci O, Sahin U, Alakus H, Fahrig L, Zander T, Buettner R, Bruns CJ, Schroeder W, Gebauer F, Quaas A. The tight junction protein claudin 6 is a potential target for patient-individualized treatment in esophageal and gastric adenocarcinoma and is associated with poor prognosis. J Transl Med. 2023 Aug 17;21(1):552. doi: 10.1186/s12967-023-04433-8. PubMed 37592303