Study of A2B694 and A2B543 CAR T-cell therapies for solid tumors
This study is testing two experimental cell therapies, A2B694 and A2B543, for people with certain solid tumors like colorectal cancer, non-small cell lung cancer, and others. These tumors must express a protein called mesothelin (MSLN) and have lost a specific genetic marker called HLA-A*02. The therapies use your own immune cells, called T-cells, which are specially modified to target and kill cancer cells while protecting healthy ones. The study aims to find a safe and effective dose of these therapies. Success will be measured by how well the therapies reduce the tumor and how safe they are, looking at side effects over 24 months. The current status of this study is unclear.
- Study design
- This is a seamless Phase 1/2, multi-center, open-label study, meaning both safety and effectiveness are being evaluated in sequence. It plans to enroll up to 474 adult participants.
- What's involved
- You will undergo screening, a procedure to collect your immune cells (apheresis), and receive a preconditioning treatment before the T-cell therapy. You will also have various study procedures and assessments.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for 24 months (2 years) after receiving the treatment, and tumor response will also be measured at 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression
At a glance
Conditions
Where it's being run
12 sites across 9 statesStudy leadership
- John Welch, MD, PhD · STUDY_DIRECTOR · A2 Biotherapeutics
Who to contact
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What this trial measures
- Phase 1: Rate of adverse events and dose limiting toxicities (DLTs) by dose levelFrom the time of Informed consent until 24 months (2 years) post infusion
Adverse Events and toxicity will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version (CTCAE) 5.0 (or current version). Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) events will be graded according to the criteria described in the current protocol.
- Phase 1: Recommended Phase 2 Dose (RP2D)21 days post infusion
The RP2D will be identified utilizing a BOIN study design in addition to considering safety and biomarker analysis.
- Phase 2: The Overall Response Rate (ORR) for patients24 months post infusion
The ORR will be evaluated per RECIST v1.1 and assessed by independent central review.