Phase 1/2a, first-in-human, open-label, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of CLDN6 CAR-T with or without CLDN6 RNA-LPX in patients with CLDN6-positive relapsed or refractory advanced solid tumors

Phase 2

Recruiting

• Conditions: cancer; tumors; 10027655

• Registration Number: NL-OMON54362
• Lead Sponsor: BioNTech Cell & Gene Therapies GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

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

-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 (<= 10 mg prednisolone daily or equivalent),
-Do not require steroid therapy within 7 d before the first dose of CLDN6
CAR-T,
-Do not have anticipated imminent fracture or cord compression due to spinal
bone metastases.
-Has 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
• Study Design: Not specified