Trial Profile

Phase I/IIa, First-in-human (FIH), 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

Status: Recruiting

Phase of Trial: Phase I

Latest Information Update: 29 Jul 2025

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At a glance

Drugs BNT 211 (Primary)
Indications Carcinoma; Endometrial cancer; Fallopian tube cancer; Gastric cancer; Germ cell cancer; Non-small cell lung cancer; Ovarian cancer; Peritoneal cancer; Sarcoma; Solid tumours; Squamous cell cancer; Testicular cancer; Uterine cancer
Focus Adverse reactions; First in man
Sponsors BioNTech

16 Jul 2025 Planned number of patients changed from 147 to 214.
16 Jul 2025 Planned End Date changed from 1 Jan 2040 to 1 Jan 2041.
16 Jul 2025 Planned primary completion date changed from 1 Jan 2027 to 1 Jan 2028.

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