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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 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2026-04-17

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

CLDN6 CAR-T

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

BIOLOGICAL

CLDN6 uRNA-LPX/CLDN6 modRNA-LPX

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

Sponsors & Collaborators

  • BioNTech Cell & Gene Therapies GmbH

    lead INDUSTRY

Principal Investigators

  • BioNTech Responsible Person · BioNTech SE

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2028-08-31
Completion
2041-08-31

Countries

  • Australia
  • Germany
  • Netherlands
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04503278 on ClinicalTrials.gov