A study to learn about the safety and efficacy of the study drug product CLDN6 CAR-T with/without the second study drug product CLDN6 RNA-LPX in patients with a specific type of advanced cancer that has reoccurred and does not respond to standard of care treatment.

Phase 1

• Conditions: CLDN6-positive relapsed or refractory advanced solid tumors; MedDRA version: 21.0Level: LLTClassification code 10043302Term: Testicular cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10046766Term: Uterine cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: LLTClassification code 10007460Term: Carcinoma of unknown primarySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-004323-20-NL
• Lead Sponsor: BioNTech Cell & Gene Therapies GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-02
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 165

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 148
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17

Exclusion Criteria

-Have received prior CAR-T therapy, except CLDN6 CAR-T/CLDN6 CART(A) therapy.
-Have received vaccination with live virus vaccines within 6 weeks prior to the start of 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:
-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 (= 10 mg prednisolone daily or equivalent),
-Do not require steroid therapy within 7 d before the first dose of CLDN6 CAR-T/CLDN6 CAR-T(A),
-Do not have anticipated imminent fracture or cord compression due to spinal bone metastases.
-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified