Actively Recruiting
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
Led by BioNTech Cell & Gene Therapies GmbH · Updated on 2026-04-17
214
Participants Needed
12
Research Sites
1089 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
Eligibility Criteria
You may qualify if you...
- Must have a tumor that is at least 50% CLDN6-positive as confirmed by a central lab test
- Must provide a recent tumor tissue sample no older than 3 years for testing
- Must have a confirmed solid tumor that is metastatic or cannot be removed by surgery
- Must have measurable disease by standard criteria or tumor markers
- Must be 18 years of age or older at time of consent
- Must be willing and able to sign informed consent and participate in trial procedures
- Must have good overall health status with performance score 0 to 1
- Must have adequate blood, liver, kidney, and clotting function as defined by the study
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control
- Men and women must agree to avoid fathering or becoming pregnant during the study and for 12 months after treatment
- Must be able to attend all required trial visits
You will not qualify if you...
- Previous CAR-T therapy other than CLDN6 CAR-T
- Vaccination with live virus within 6 weeks before starting treatment
- Use of systemic steroids over 10 mg prednisolone daily
- Unresolved side effects from prior treatments at grade 1 or higher
- New or growing brain or spinal metastases unless stable and treated as specified
- History of epilepsy or recent cerebrovascular event within 6 months
- Pericardial effusion requiring drainage
- Active autoimmune disease requiring immunosuppressive treatment (with some exceptions)
- HIV infection
- Active hepatitis B or C infection requiring treatment
- Known allergy to study drugs or similar compounds
- Severe reaction history to study chemotherapy drugs
- Other primary cancers within past 2 years (exceptions apply)
- Prior allogeneic stem cell transplant within 5 years
- Acute or chronic graft versus host disease
- Significant heart, lung, or other medical conditions posing safety risk
- Cognitive or psychological issues preventing trial compliance
- Pregnant or breastfeeding
- Pure beta-hCG-secreting germ cell tumor
AI-Screening
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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
Research Team
B
BioNTech clinical trials patient information
CONTACT
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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