A Trial to Evaluate the Safety and Efficacy of CLDN6 CAR-T +/- CLDN6 RNA-LPX

  • End date
    Sep 23, 2036
  • participants needed
  • sponsor
    BioNTech Cell & Gene Therapies GmbH
Updated on 23 June 2021
BioNTech clinical trials patient information
Primary Contact
Universit tsklinikum Erlangen - H matologie & Intrinsische Onkologie - Medizinische Klinik 5 (8.7 mi away) Contact
+5 other location
measurable disease
solid tumor
kidney function test


This is a Phase I/IIa, FIH, open-label, multicenter, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of CLDN6 CAR-T +/- CLDN6 RNA-LPX in patients with CLDN6-positive relapsed or refractory advanced solid tumors.

Condition Solid Tumors, Solid Tumor, Solid Neoplasm, Solid Tumour
Clinical Study IdentifierNCT04503278
SponsorBioNTech Cell & Gene Therapies GmbH
Last Modified on23 June 2021


Yes No Not Sure

Inclusion Criteria

Phase 1 of the trial
Each patient enrolled in the trial must have CLDN6-positive tumor regardless of tumor histology defined as 50% of tumors expressing 2+ CLDN6 protein using a semi-quantitative immunohistochemistry (IHC) assay in a central laboratory for specific detection of CLDN6 protein expression in formalin-fixed, paraffin-embedded (FFPE) neoplastic tissues
Availability of a FFPE tumor tissue sample. FFPE can be from an archival tumor tissue sample, and it should be from the most recent tumor tissue obtained. If this is not available, patient must be biopsied for CLDN6 staining
Must have histological documentation of the original primary tumor via a pathology report
Must have measurable disease per RECIST 1.1 (except for Germ Cell Tumors, where patients can be evaluated according to Cancer-Antigen (CA)-125, Alpha-fetoprotein (AFP) or human chorionic gonadotropin (hCG) [as applicable] if they have a pre-treatment sample that is at least twice the upper limit of normal)
Must have a histologically confirmed solid tumor that is metastatic or unresectable and for whom there is no available standard therapy likely to confer clinical benefit, or patient who is not a candidate for such available therapy
Must be 18 years of age at the time the pre-screening informed consent is signed
Must have an Eastern Cooperative Oncology Group performance status of 0 to 1
Must have adequate coagulation function at screening as defined in the protocol
Must have adequate hepatic function at screening as defined in the protocol
Must have adequate renal function at screening as defined in the protocol
Must be able to attend trial visits as required by the protocol
Women of childbearing potential (WOCBP) must have a negative serum (beta-human chorionic gonadotropin) test/value at screening. Patients who are post-menopausal or permanently sterilized can be considered as not having reproductive potential
WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and thereafter
WOCBP and men that are sexually active with a WOCBP and have not had a vasectomy must agree to use highly effective birth control method(s), such as barrier method of birth control, e.g., either condom with spermicidal foam/gel/film/cream/suppository for men; and/or for females occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; an intrauterine device; and/or hormone-based contraception, with established use of oral, injected, or implanted hormonal methods of contraception. True abstinence is an acceptable alternative to the use of contraception
Men must agree not to father a child or donate sperm, and WOCBP must agree not to become pregnant during the trial and for at least 12 months after the CLDN6 CAR-T infusion or CLDN6 RNA-LPX treatment
For Part 2 only
Histologically or cytologically confirmed solid tumor fulfilling inclusion criteria 1-4 that is metastatic or unresectable, and for whom there is no available standard therapy likely to confer clinical benefit, or patient who is not a candidate for such available therapy

Exclusion Criteria

Phase 1 of the trial
Has received prior CAR-T cell therapy
Has received vaccination with live virus vaccines within 6 weeks prior to the start of lymphodepletion (LD)
Receives concurrent systemic (oral or i.v.) steroid therapy > 10 mg prednisolone daily, or its equivalent, for an underlying condition
Has side effects of any prior therapy or procedures for any medical condition not recovered to national cancer institute (NCI) common terminology criteria for adverse events (CTCAE v.5) Grade 1
Medical conditions
Current evidence of new or growing brain or spinal metastases during screening. Patients with known brain or spinal metastases may be eligible if they
Have had radiotherapy or another appropriate therapy for the brain or spinal metastases
Have no neurological symptoms
Have stable brain or spinal disease on the computer tomography (CT) or magnetic resonance imaging (MRI) scan within 4 weeks before signing of the Informed consent form
Are not undergoing acute corticosteroid therapy or steroid taper. Chronic steroid therapy is acceptable provided that the dose is stable for the last 14 d prior to screening ( 10 mg prednisolone daily or equivalent)
Do not require steroid therapy within 7 d before the first dose of CLDN6 CAR-T
Have anticipated imminent fracture or cord compression due to spinal bone metastases
Has history of epilepsy. Isolated seizures in the past or febrile seizures in childhood are permitted; has a history of a cerebrovascular accident or transient ischemic attack less than 6 months ago
Pericardial effusion requiring any drainage is excluded
Has an active autoimmune disease including but not limited to inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Has any active immunologic disorder requiring immunosuppression with steroids or other immunosuppressive agents with the exception of patients with isolated vitiligo, resolved childhood asthma or atopic dermatitis, controlled hypoadrenalism or hypopituitarism, and euthyroid patients with a history of Grave's disease. Patients with controlled hyperthyroidism must be negative for thyroglobulin, thyroid peroxidase antibodies, and thyroid-stimulating immunoglobulin prior to trial drug administration
Seropositivity for human immunodeficiency virus (HIV)
Known history/positive serology for hepatitis B requiring active antiviral therapy (unless immune due to vaccination or resolved natural infection or unless passive immunization due to immunoglobulin therapy). Patients with positive serology must have hepatitis B virus viral load below the limit of quantification
Active Hepatitis C virus (HCV) infection; patients who have completed curative antiviral treatment with HCV viral load below the limit of quantification are allowed
Has a known hypersensitivity to a component of CLDN6 CAR-T or CLDN6 RNA-LPX cancer vaccine drug product, or another similar compound
History of severe immediate hypersensitivity reaction to LD chemotherapy consisting of cyclophosphamide or fludarabine
Has a history of another primary cancer within the 2 years prior to enrollment except for the following: Non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, prostate cancer with currently undetectable prostate specific antigen, or other non-metastatic carcinoma that has been in complete remission without treatment for more than 2 years
Receipt of allogenic stem cell transplantation in the 5 years prior to enrollment into the trial
Patients with acute or chronic graft versus host disease
Other comorbidities
Has abnormal electrocardiograms (ECGs) that are clinically significant, such as QT prolongation
In the opinion of the Investigator, has any concurrent conditions that could pose an undue medical hazard or interfere with the interpretation of the trial results; these conditions include, but are not limited to
Ongoing or active infection requiring antibiotic/antiviral/antifungal therapy
Concurrent congestive heart failure (New York Heart Association Functional Classification Class III or IV)
Concurrent unstable angina
Concurrent cardiac arrhythmia requiring treatment (excluding asymptomatic atrial fibrillation)
Acute coronary syndrome within the previous 6 months
Significant pulmonary disease (shortness of breath at rest or on mild exertion) for example due concurrent severe obstructive pulmonary disease
Has a cognitive, psychological or psychosocial impediment that would impair the ability of the patient to receive therapy according to the protocol or adversely affect the ability of the patient to comply with the informed consent process, protocol, or protocol-required visits and procedures
Is pregnant or breastfeeding
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