CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 214 target
Drug / intervention
CLDN6 CAR-T +1 morebiological
Likely dose
Not stated in record
Key inclusion· 7
  • ✓CLDN6-positive tumor with ≥50% of tumor cells expressing CLDN6 protein at intensity ≥2+ on immunohistochemistry in central laboratory
  • ✓Availability of FFPE tumor tissue sample (archival ≤3 years old or fresh biopsy if post-treatment CLDN6 expression may have changed)
  • ✓Histologically confirmed metastatic or unresectable solid tumor with no available standard therapy likely to provide benefit or patient not a candidate for such therapy
  • ✓Measurable disease per RECIST v1.1 (or tumor markers for germ cell and ovarian cancers)
Key exclusion· 16
  • ✕Prior CAR-T therapy (except CLDN6 CAR-T)
  • ✕Live virus vaccination within 6 weeks prior to start of lymphodepletion
  • ✕Systemic corticosteroids >10 mg prednisolone daily or equivalent for underlying condition
  • ✕Unrecovered adverse events from prior therapy (Grade >1 per CTCAE v5.0)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04503278
NCT04503278Phase 1ActiveHigh Momentum
CompareCT.gov

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

BioNTech Cell & Gene Therapies GmbH·interventional·Posted Aug 7, 2020·Updated Jun 18, 2026

In Brief

A Phase 1 clinical trial evaluating CLDN6 CAR-T and CLDN6 uRNA-LPX/CLDN6 modRNA-LPX for Solid Tumor. Active but no longer recruiting, targeting 214 participants across 12 sites in 4 countries.

Signals

Enrolling ahead of pace

Detailed Summary

This is a Phase I, FIH, open-label, multi-site, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of claudin 6 (CLDN6) chimeric antigen receptor T cells (CAR-T) with or without CLDN6 ribonucleic acid lipoplexes (RNA-LPX) in patients with CLDN6-positive relapsed or refractory advanced solid tumors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor
CountriesAustralia, Germany, Netherlands, Sweden
Collaborators--

Timeline

Phase 1Active
2021202220232024202520262027202820292030203120322033203420352036203720382039204020412042
First PostedAug 7, 2020
Enrollment StartSep 16, 2020
Primary CompletionAug 1, 2028
Study CompletionAug 1, 2041
TodayJul 2, 2026
Enrollment to primary: 7.9 yearsPosted 5.9 years agoPrimary completion in 2.1 years

Interventions

CLDN6 CAR-Tbiological

administered as an intravenous (i.v.) infusion.

CLDN6 uRNA-LPX/CLDN6 modRNA-LPXbiological

administered as an i.v. injection at protocol-specified intervals.