A Phase 1/2 interventional study of A2B530 and xT-Onco with HLA-LOH Assay in Solid Tumor, Adult, Solid Tumor and Pancreatic Cancer, sponsored by A2 Biotherapeutics Inc.. Active, not recruiting at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-25.
Sponsored by A2 Biotherapeutics Inc. · Phase 1/2, Interventional, and Treatment
The goal of this study is to test A2B530,an autologous logic-gated Tmod™ 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:
Participants will be required to perform study procedures and assessments, and will also receive the following study treatments:
This is a phase 1/2, multi-center, open-label study that enrolls adult subjects with recurrent unresectable, locally advanced, or metastatic (considered non-curative) CRC, NSCLC, PANC, or other solid tumors with CEA expression. Subjects must be germline HLA-A*02 heterozygous, with tumors that express CEA and somatic loss of HLA-A*02. The purpose of Phase 1 of this study is to determine the safety and the optimal dose of A2B530 (after PCLD) in participants with solid tumor disease. The purpose of Phase 2 of this study is to determine the further safety and efficacy (how well it treats the solid tumor disease) of A2B530.
The treatment available for these cancers and other solid tumors can be toxic, debilitating, and fatal. In the recurrent unresectable, locally advanced, or metastatic setting, the intent of standard of care treatment is typically palliative rather than curative, and has not changed significantly in several decades. A2 Bio hypothesizes that A2B530 Tmod CAR T-cell therapy will enable the killing of tumor target cells (those cells that express CEA and have LOH for HLA-A*02 protein). Additionally, normal healthy cells that maintain HLA-A*02 expression and co-express CEA (eg, gut mucosal tissue) will not be targeted due to the blocker portion of the Tmod CAR T cell that acts as a self-regulated safety switch that protects normal tissue from damage. A2 Bio believes this will provide a therapeutic safety window compared to previous solid tumor targeting therapies. This hypothesis will be explored in the study.
Participants for this study must enroll and have their T cells collected (apheresis) in the pre-screening BASECAMP-1 study (NCT04981119). T cells are collected, processed and stored for each participant. Upon disease progression the participant may screen for this study (EVEREST-1) and the participant's T cells are then manufactured and infused following PCLD regimen. There is no time requirement between the studies, and patients may go directly from BASECAMP-1 to EVEREST-1 based on their own disease course.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 160 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →A2 Biotherapeutics Inc. is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
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Key Inclusion Criteria:
Key Exclusion Criteria:
Patients receive Preconditioning Lymphodepletion (PCLD) Regimen followed by a single dose of A2B530 intravenously on day 0
Biological: A2B530 · Diagnostic Test: xT-Onco with HLA-LOH Assay
Autologous logic-gated Tmod CAR T-cells
Also known as: Tmod CAR T-cell Therapy
An investigational next generation sequencing (NGS) in vitro diagnostic (IVD) medical device
Phase 1: Rate of adverse events and dose limiting toxicities (DLTs) by dose level
Adverse Events and toxicity will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 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.
Time frame: From the time of Informed consent until 24 months (2 years) post A2B530 infusion.
Phase 1: Recommended Phase 2 Dose (RP2D)
The RP2D will be identified utilizing a BOIN study design in addition to considering safety and biomarker analysis.
Time frame: 21 days post A2B530 infusion
Phase 2: The Overall Response Rate (ORR) for patients
The ORR will be evaluated per RECIST v1.1 and assessed by independent central review.
Time frame: 24 months post A2B530 infusion
Persistence of A2B530
Number of A2B530 Tmod CAR T cells present in patients treated with A2B530 as assessed by Polymerase Chain Reaction (PCR) (or similar method) on participant blood samples
Time frame: up to 24 months post A2B530 infusion
Cytokine analysis
Cytokine levels in patients treated with A2B530 assessed by cytokine analysis on participant blood samples
Time frame: up to 24 months post A2B530 infusion
Plan to share: Yes — Study data will be shared within 1 year of study completion.
Supporting information: Csr
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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A2 Biotherapeutics Inc.