OncoMatch/Clinical Trials/NCT04503278
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
Is NCT04503278 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including CLDN6 CAR-T and CLDN6 uRNA-LPX/CLDN6 modRNA-LPX for solid tumor.
Treatment: CLDN6 CAR-T · CLDN6 uRNA-LPX/CLDN6 modRNA-LPX — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Biomarker criteria
Required: CLDN6 expression ≥50% cells at ≥2+ intensity (≥50% of tumor cells expressing CLDN6 protein at an intensity of ≥2+ by IHC)
CLDN6-positive tumor regardless of tumor histology defined as ≥ 50% of tumor cells expressing CLDN6 protein at an intensity of ≥2+ using a semi-quantitative immunohistochemistry assay in a central laboratory
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: CAR-T cell therapy
Exception: except CLDN6 CAR-T therapy
Has received prior CAR-T therapy, except CLDN6 CAR-T therapy.
Cannot have received: allogenic stem cell transplantation
Receipt of allogenic stem cell transplantation in the 5 years prior to enrollment into the trial.
Lab requirements
Blood counts
adequate hematologic function at screening as defined in the protocol
Kidney function
adequate renal function at screening as defined in the protocol
Liver function
adequate hepatic function at screening as defined in the protocol
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04503278 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR-T cell therapy, allogenic stem cell transplantation disqualifies patients from enrollment.
Does this trial require CLDN6?
Yes, CLDN6 expression ≥50% cells at ≥2+ intensity is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify