NCT04503278

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

Recruiting now Phase 1 Last updated 14 April 2026

What this trial tests

Phase 1 trial testing CLDN6 CAR-T in Solid Tumor in 214 participants. Currently enrolling.

Timeline

16 September 2020

Primary endpoint
1 August 2028

1 August 2041

Quick facts

Lead sponsor	BioNTech Cell & Gene Therapies GmbH
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	factorial
Masking	none
Primary purpose	treatment
Enrollment	214
Start date	16 September 2020
Primary completion	1 August 2028
Estimated completion	1 August 2041
Sites	12 locations across Australia, Germany, Netherlands, Sweden

Drugs / interventions tested

• CLDN6 CAR-T — full drug profile →
• CLDN6 uRNA-LPX/CLDN6 modRNA-LPX — full drug profile →

Conditions studied

• Solid Tumor — all drugs for Solid Tumor →

Sponsor

BioNTech Cell & Gene Therapies GmbH — full company profile →

Who can join

18 and older, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Occurrence of treatment-emergent adverse events (TEAEs) including ≥ Grade 3, serious, fatal TEAEs by relationship
  Time frame: up to 25 months
• Occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAEs
  Time frame: up to 25 months
• Occurrence of dose-limiting toxicity (DLT) during the DLT evaluation period
  Time frame: Day 1 to day 28

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. T cells in health and disease.
   Sun L, Su Y, Jiao A, Wang X, et al · · 2023 · cited 717× · PMID 37332039 · DOI 10.1038/s41392-023-01471-y
2. CAR-cell therapy in the era of solid tumor treatment: current challenges and emerging therapeutic advances.
   Maalej KM, Merhi M, Inchakalody VP, Mestiri S, et al · · 2023 · cited 421× · PMID 36717905 · DOI 10.1186/s12943-023-01723-z
3. Passive, active and endogenous organ-targeted lipid and polymer nanoparticles for delivery of genetic drugs.
   Dilliard SA, Siegwart DJ. · · 2023 · cited 384× · PMID 36691401 · DOI 10.1038/s41578-022-00529-7
4. Clinical advances and ongoing trials on mRNA vaccines for cancer treatment.
   Lorentzen CL, Haanen JB, Met Ö, Met Ö, et al · · 2022 · cited 362× · PMID 36174631 · DOI 10.1016/s1470-2045(22)00372-2
5. mRNA therapeutics in cancer immunotherapy.
   Beck JD, Reidenbach D, Salomon N, Sahin U, et al · · 2021 · cited 266× · PMID 33858437 · DOI 10.1186/s12943-021-01348-0
6. CLDN6-specific CAR-T cells plus amplifying RNA vaccine in relapsed or refractory solid tumors: the phase 1 BNT211-01 trial.
   Mackensen A, Haanen JBAG, Koenecke C, Alsdorf W, et al · · 2023 · cited 215× · PMID 37872225 · DOI 10.1038/s41591-023-02612-0
7. Nanoparticles in the clinic: An update post COVID-19 vaccines.
   Anselmo AC, Mitragotri S. · · 2021 · cited 211× · PMID 34514159 · DOI 10.1002/btm2.10246
8. Current status and perspective of CAR-T and CAR-NK cell therapy trials in Germany.
   Albinger N, Hartmann J, Ullrich E. · · 2021 · cited 171× · PMID 33753909 · DOI 10.1038/s41434-021-00246-w