cancer tumors
Conditions
Interventions
All patients will receive one infusion of CLDN6 CAR-T/CLDN6 CAR-T(A) with or
without additional treatment with the CLDN6 (mod)RNA-LPX vaccine. Patients in
Part 1 may be re-dosed at month 2.
Sponsors
BioNTech Cell & Gene Therapies GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Must have a CLDN6-positive tumor regardless of tumor histology defined as >= 50% of tumor cells expressing >= 2+ CLDN6 protein using a semi-quantitative immunohistochemistry (IHC) assay for specific detection of CLDN6 protein expression in formalin-fixed, paraffinembedded neoplastic tissues. -Must have measurable disease per RECIST 1.1 (except for germ cell tumor or ovarian cancer patients). -Germ cell cancer patients without initial measurable disease per RECIST 1.1 and evaluable by cancer antigen (CA)-125, alphafetoprotein (AFP) or human chorionic gonadotropin (hCG; as applicable) are eligible for the trial. -Ovarian cancer patients without initial measurable disease per RECIST 1.1. and evaluable by CA-125 are eligible for the trial. -Must have a histologically confirmed solid tumor that is metastatic or unresectable and for which there is no available standard therapy likely to confer clinical benefit, or patient who is not a candidate for such available therapy.
Exclusion criteria
Exclusion criteria: -Have received prior CAR-T therapy, except CLDN6 CAR-T therapy. -Have received vaccination with live virus vaccines within 6 weeks prior to the start of lymphodepletion (LD). -Receives concurrent systemic (oral or intravenous [i.v.]) steroid therapy > 10 mg prednisolone daily, or its equivalent, for an underlying condition. -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 or magnetic resonance imaging scan within 4 weeks before signing of the informed consent, -Must not be 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 (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary - Occurrence of TEAEs within a patient including >= Grade 3, serious, fatal TEAEs by relationship - Occurrence of dose reduction and discontinuation of IMP within a patient due to TEAEs - Occurrence of DLTs within a patient during the DLT evaluation period Long term follow-up - Primary - Occurrence of AEs during the LTFU period suspected to be related to CLDN6 CAR-T/CLDN6 CAR-T(A) +/- CLDN6 (mod)RNA-LPX, such as: o New malignancy (hematologic or solid) o New neurologic disorder, or exacerbation of a pre-existing disorder o New rheumatologic or autoimmune disorder, or exacerbation of a prior rheumatologic or other autoimmune disorder o New hematologic disorder o Other new clinical condition considered by the Investigator to be related to the prior genetically engineered T cell therapy Long term follow-up - Secondary - Progression-free survival - Overall survival. Survival status will be collected until 15 years from last genetically engineered T cell infusion or until death, whichever occurs first | — |
Secondary
| Measure | Time frame |
|---|---|
| -To describe the profile of soluble immune factors in CLDN6 CAR-T +/- CLDN6 RNA-LPX -To evaluate anti-tumor activity of CLDN6 CAR-T +/- CLDN6 RNA-LPX according to response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) | — |
Countries
Netherlands
Outcome results
None listed