A Study to Evaluate the Safety and Efficacy of A2B530, a Logic-gated CAR T, in Participants With … (NCT05736731) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study to Evaluate the Safety and Efficacy of A2B530, a Logic-gated CAR T, in Participants With Solid Tumors That Express CEA and Have Lost HLA-A*02 Expression
United States160 participantsStarted 2023-04-28
Plain-language summary
The goal of this study is to test A2B530,an autologous logic-gated Tmodâ„¢ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), and other solid tumors that express CEA and have lost HLA-A\*02 expression.
The main questions this study aims to answer are:
* Phase 1: What is the maximum or recommended dose of A2B530 that is safe for patients
* Phase 2: Does the recommended dose of A2B530 kill the solid tumor cells and protect the patient's healthy cells
Participants will be required to perform study procedures and assessments, and will also receive the following study treatments:
* Enrollment and Apheresis in BASECAMP-1 (NCT04981119)
* Preconditioning Lymphodepletion (PCLD) Regimen
* A2B530 Tmod CAR T cells at the assigned dose
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\*02:01 by NGS (whenever possible from the primary site), successful apheresis and PBMC processing, and with sufficient stored cells available for Tmod CAR T-cell therapy
✓. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, PANC, or other solid tumors associated with CEA expression. Measurable disease is required with lesions of \>1.0 cm by computed tomography (CT). (Soluble CEA is not acceptable as the sole measure of disease).
✓. Received previous required therapy for the appropriate solid tumor disease as described in the protocol
✓. Has adequate organ function as described in the protocol
✓. ECOG performance status of 0 to 1
✓. Life expectancy of ≥3 months
✓. Willing to comply with study schedule of assessments including long term safety follow up
Exclusion criteria
✕. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative
What they're measuring
1
Phase 1: Rate of adverse events and dose limiting toxicities (DLTs) by dose level
Timeframe: From the time of Informed consent until 24 months (2 years) post A2B530 infusion.
2
Phase 1: Recommended Phase 2 Dose (RP2D)
Timeframe: 21 days post A2B530 infusion
3
Phase 2: The Overall Response Rate (ORR) for patients
✕. Cancer therapy within 3 weeks or 3 half lives of A2B530 infusion
✕. Radiotherapy within 28 days of A2B530 infusion
✕. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months
✕. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated.