BridgeMD
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
EU CTIS ID: 2024-514962-38-00
What this study is testing
To assess the safety and tolerability of claudin 6 (CLDN6) chimeric antigen receptor T cell (CAR-T) ± CLDN6 liposomally-formulated vaccine encoding ribonucleic acid (RNA-LPX) and to assess the comparability of CLDN6 CAR-T from the manual and automated processes, and to identify the maximum tolerated dose (MTD)/(recommended phase 2 dose) RP2D for each IMP (i.e., CLDN6 CAR-T ± CLDN6 RNA-LPX) based on the occurrence of dose-limiting toxicities (DLT) using the following definitions: 1) MTD is defined as the highest tolerated dose of CLDN6 CAR-T ± CLDN6 RNA-LPX where less than 33% of the patients experience a DLT, and 2) RP2D of CLDN6 CAR-T ± CLDN6 RNA-LPX based on integrated evaluation of safety and other data for all dose levels tested.
- Human Pharmacology (Phase I)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Must have a 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 (IHC) assay for specific detection of CLDN6 protein expression in formalin-fixed, paraffin-embedded neoplastic tissues.
- Must have measurable disease per RECIST 1.1 (except for germ cell tumor where patients can be evaluated according to cancer antigen (CA)-125, AFP, or beta human chorionic gonadotropin [βhCG] [as applicable] or ovarian cancer patients where patients can be evaluated according to CA-125. The pre-treatment sample must be at least twice the upper limit of normal [ULN]).
- Must have a histologically confirmed solid tumor that is metastatic or unresectable and for whom there is no available standard therapy likely to confer clinical benefit, or the patient is not a candidate for such available therapy.
You likely can't join if
- Has received prior CAR-T therapy, except CLDN6 CAR-T therapy.
- Has received vaccination with live virus vaccines within 6 weeks prior to the start of lymphodepletion (LD).
- Receives concurrent systemic (oral or 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.