A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With an… (NCT04503278) | Clinical Trial Compass
Active — Not RecruitingPhase 1
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
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Have had radiotherapy or another appropriate therapy for the brain or spinal metastases. The therapy must be completed at least 3 weeks prior to CLDN6 CAR-T administration,
. Have no neurological symptoms,
. Have stable brain or spinal disease on the computer tomography or magnetic resonance imaging scan within 3 weeks before CLDN6 CAR-T administration,
. Are not undergoing acute corticosteroid therapy or steroid taper. Chronic steroid therapy is acceptable provided that the dose is stable for the last 14 days prior to screening (≤10 mg prednisolone daily or equivalent),
. Do not require steroid therapy within 7 days before the first dose of CLDN6 CAR-T, and
. Do not have anticipated imminent fracture or cord compression due to spinal bone metastases.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused primarily on finding safe doses and tracking serious side effects — including life-threatening ones — rather than proving the treatment works, how does that change the risk-benefit calculation for someone in my situation compared to standard treatment options?
2This trial combines an investigational cell therapy with an investigational RNA-based vaccine, meaning both components are experimental — can you walk me through what is currently known about the safety profile of each, and what the most serious side effects to watch for might be?
3The trial is listed as 'active but no longer recruiting,' so if I can't enroll, are there similar or follow-on studies I might be eligible for, or would standard care be the more appropriate next step for me right now?
4Because dose-limiting toxicities are one of the main things being measured, what would happen if I experienced a serious adverse event — would I need to stop treatment, and what would my care look like after that?
5Given that this trial is for solid tumors generally, how well does my specific tumor type and stage match what this study was designed to evaluate, and does that affect whether it would even be worth pursuing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of treatment-emergent adverse events (TEAEs) including ≥ Grade 3, serious, fatal TEAEs by relationship
Timeframe: up to 25 months
2
Occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAEs
Timeframe: up to 25 months
3
Occurrence of dose-limiting toxicity (DLT) during the DLT evaluation period