A2B395 for Solid Tumors with EGFR Expression and HLA-A*02 Loss
This study is testing a new treatment called A2B395, which is a type of CAR T-cell therapy. It's for adults with certain advanced solid tumors, like colorectal cancer or non-small cell lung cancer, that express EGFR (a protein on cancer cells) and have lost HLA-A*02 (another protein). The study aims to find a safe dose of A2B395 and see how well it shrinks tumors while protecting healthy cells. To join, your tumor tissue must show this specific loss of HLA-A*02. The study plans to enroll 240 participants, but its current status is unclear.
- Study design
- This is a seamless Phase 1/2, multi-center, open-label study. It will enroll adult participants to determine the safety and effectiveness of A2B395.
- What's involved
- You would first enroll in the BASECAMP-1 study. You will also undergo study procedures and assessments, and receive the A2B395 treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to 24 months (2 years) after receiving A2B395. 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 A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression
At a glance
Conditions
Where it's being run
10 sites across 8 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 A2B395 infusion
Adverse events and toxicity will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (or current version). Cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and graft versus host disease (GvHD) events will be graded according to the criteria described in the current protocol.
- Phase 1: Recommended phase 2 dose (RP2D)28 days post A2B395 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 A2B395 infusion
The ORR will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and assessed by independent central review.