CLDN6-specific CAR-T cells plus amplifying RNA vaccine in relapsed or refractory solid tumors: the phase 1 BNT211-01 trial.
Andreas Mackensen, John B A G Haanen, Christian Koenecke...
https://pubmed.ncbi.nlm.nih.gov/37872225Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID04503278
Phase I/IIa First-in-human Dose Escalation Trial Evaluating Safety and Preliminary Efficacy of CLDN6 CAR-T With or Without CLDN6 RNA-LPX in CLDN6-positive Relapsed or Refractory Advanced Solid Tumors
Led by BioNTech Cell & Gene Therapies GmbH · Updated on 2026-04-17
214
Participants Needed
12
Research Sites
678 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and early effectiveness of an investigational cell therapy called CLDN6 CAR-T, with or without an RNA-based vaccine (CLDN6 RNA-LPX), in patients who have CLDN6-positive relapsed or refractory advanced solid tumors. This Phase I, open-label, dose escalation study aims to determine safe dosage levels and observe initial treatment responses in these patients. The study consists of two parts. Part 1 involves dose escalation of CLDN6 CAR-T cells produced manually or via an automated process, given after lymphodepletion, to find the maximum tolerated dose or recommended phase 2 dose. Part 2 adds a vaccine-modulated dose escalation using CLDN6 RNA-LPX to optimize CAR-T cell persistence. Treatments are given as intravenous infusions or injections at specified intervals. After the main trial period of 25 months, participants may join a long-term follow-up lasting up to 15 years to monitor safety and effects. Participants undergo tumor tissue testing for CLDN6 expression and must have measurable metastatic or unresectable solid tumors without effective standard therapy. During the trial, researchers will monitor treatment-emergent adverse events, dose-limiting toxicities, and changes in immune factors. The study also measures tumor response rates and disease control over time. Regular visits and assessments are required throughout the treatment and follow-up periods to evaluate safety and preliminary efficacy.
CONDITIONS
Brief Title
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
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Have a tumor with at least 50% of cells expressing CLDN6 protein at a specific intensity confirmed by a central laboratory
- Provide a tumor tissue sample obtained within the last 3 years or a fresh biopsy if needed
- Have histological documentation of the original primary tumor
- Have measurable metastatic or unresectable solid tumor disease without available standard therapy
- Be 18 years of age or older at the time of consent
- Sign informed consent and understand trial procedures
- Have an Eastern Cooperative Oncology Group performance status of 0 or 1
- Have adequate blood clotting, blood cell counts, liver, and kidney function as defined in the protocol
- Be able to attend trial visits as required
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after the trial
- Men must agree to use effective birth control or abstain from fathering a child during and after the trial
You will not qualify if you...
- Received prior CAR-T therapy other than CLDN6 CAR-T
- Had live virus vaccinations within 6 weeks before lymphodepletion
- Currently taking systemic steroids above a specified dose for other conditions
- Have side effects from previous treatments not recovered to a mild level
- Have new or growing brain or spinal metastases with symptoms or unstable disease
- History of epilepsy or recent cerebrovascular events
- Have pericardial effusion requiring drainage
- Have active autoimmune diseases requiring immunosuppression
- Are HIV positive or have active hepatitis B or C infections
- Have allergies to components of the study treatments
- History of severe allergic reactions to related chemotherapy drugs
- Have another primary cancer within 2 years except certain exceptions
- Received allogenic stem cell transplant within the last 5 years
- Have acute or chronic graft versus host disease
- Have significant heart, lung, or other medical conditions posing risk
- Have cognitive or psychological issues affecting consent or compliance
- Are pregnant or breastfeeding
- Have a pure beta-hCG-secreting germ cell tumor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 25 months
Participants receive investigational CLDN6 CAR-T cells with or without CLDN6 RNA-LPX through intravenous infusions as part of a dose escalation protocol to evaluate safety and preliminary efficacy.
Multiple visits for dosing and monitoring during treatment
Long-term Monitoring
Duration - Up to 15 years
After completing or discontinuing treatment, participants are followed for long-term safety and efficacy of the investigational therapies.
Periodic visits over long-term follow-up
Trial Site Locations
Total: 12 locations
1
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Completed
2
Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
Berlin, Germany, 12200
Actively Recruiting
3
Universitätsklinikum Köln AÖR-Centrum für Integrierte Onkologie (CIO)-Studienzentrum der Klinik I für Innere Medizin (CTU Cologne)
Cologne, Germany, 50937
Actively Recruiting
4
Universitätsklinikum Erlangen - Hämatologie & Intrinsische Onkologie - Medizinische Klinik 5
Erlangen, Germany, 91054
Actively Recruiting
5
Universitätsklinikum Hamburg Eppendorf - II Medizinische Klinik und Poliklinik
Hamburg, Germany, 20246
Actively Recruiting
6
Medizinische Hochschule Hannover - Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
Hanover, Germany, 30625
Actively Recruiting
7
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
8
Universitätsmedizin Mainz - III Medizinische Klinik und Poliklinik
Mainz, Germany, 55131
Actively Recruiting
9
Universitätsklinikum Regensburg - Klinik und Poliklinik für Innere Medizin III
Regensburg, Germany, 93053
Actively Recruiting
10
He Nederlands Kanker Instituut (The Netherlands Cancer Institute) - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)
Amsterdam, Netherlands, 1066
Actively Recruiting
11
Erasmus MC - Universitair Medisch Centrum - Medical oncology
Rotterdam, Netherlands, 3015
Actively Recruiting
12
Karolinska Comprehensive Cancer Center Cancerstudieenheten Huddinge Karolinska Universitetssjukhuset
Stockholm, Sweden, 14186
Actively Recruiting
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Research Team
B
BioNTech clinical trials patient information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
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