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Experimental CAR-T therapy takes on Hard-to-Treat cancers

NCT ID NCT04503278

Ongoing Disease control Sponsor: BioNTech Cell & Gene Therapies GmbH Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a new treatment for people with advanced solid tumors that have a specific marker called CLDN6. The treatment uses specially engineered immune cells (CAR-T cells) that target CLDN6, sometimes combined with a genetic booster (RNA-LPX) to enhance their activity. The main goals are to check safety and find the right dose, with a preliminary look at whether the tumors shrink.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
CLDN6 CAR-T cells (a type of immune cell therapy) and CLDN6 RNA-LPX (a genetic vaccine booster)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is a very early (Phase 1) trial with only 214 participants, so it is primarily testing safety. The treatment may not shrink tumors or may cause serious side effects like cytokine release syndrome.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

endometrium neoplasm gastric neoplasm neoplasm non-small cell lung carcinoma ovarian cancer testicular cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SOLID TUMOR

Contacts and locations

Locations

  • Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin

    Berlin, 12200, Germany

  • Erasmus MC - Universitair Medisch Centrum - Medical oncology

    Rotterdam, 3015, Netherlands

  • He Nederlands Kanker Instituut (The Netherlands Cancer Institute) - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)

    Amsterdam, 1066, Netherlands

  • Karolinska Comprehensive Cancer Center Cancerstudieenheten Huddinge Karolinska Universitetssjukhuset

    Stockholm, 14186, Sweden

  • Medizinische Hochschule Hannover - Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation

    Hanover, 30625, Germany

  • Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg

    Heidelberg, 69120, Germany

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Universitätsklinikum Erlangen - Hämatologie & Intrinsische Onkologie - Medizinische Klinik 5

    Erlangen, 91054, Germany

  • Universitätsklinikum Hamburg Eppendorf - II Medizinische Klinik und Poliklinik

    Hamburg, 20246, Germany

  • Universitätsklinikum Köln AÖR-Centrum für Integrierte Onkologie (CIO)-Studienzentrum der Klinik I für Innere Medizin (CTU Cologne)

    Cologne, 50937, Germany

  • Universitätsklinikum Regensburg - Klinik und Poliklinik für Innere Medizin III

    Regensburg, 93053, Germany

  • Universitätsmedizin Mainz - III Medizinische Klinik und Poliklinik

    Mainz, 55131, Germany

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