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NCT05736731 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Non-Small Cell Lung Cancer and Pancreatic Cancer, sponsored by A2 Biotherapeutics.
- Active
- Registry status
- Phase 1
- Development phase
- 160
- Enrollment target
- 8
- Study locations
NCT05736731: Active Phase 1 study of Non-Small Cell Lung Cancer and Pancreatic Cancer, sponsored by A2 Biotherapeutics.
NCT05736731 is a Phase 1 study of Non-Small Cell Lung Cancer and Pancreatic Cancer that is active but no longer recruiting, run by A2 Biotherapeutics. The registered enrollment target is 160 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (75% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05736731, a Phase 1 study of Non-Small Cell Lung Cancer and Pancreatic Cancer, is active but no longer recruiting, sponsored by A2 Biotherapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 160 participants
- Enrollment target
- 8
- Study locations
Study Summary
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: * 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
Primary Outcome
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.
Conditions Studied
Interventions
- BIOLOGICAL A2B530
- DIAGNOSTIC_TEST xT-Onco with HLA-LOH Assay
Study Locations (8)
California
- University of California San Diego - La Jolla
- UCLA Medical Center - Los Angeles
Arizona
- Banner Health - Gilbert
Florida
- Moffitt Cancer Center - Tampa
Minnesota
- Mayo Clinic Rochester - Rochester
Missouri
- Washington University - St Louis
New York
- NYU Langone Medical Center - New York
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2023-04-28 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What the registry record for NCT05736731 still lists
NCT05736731 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (75% lower).
The record links to 10 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which A2B530 is the first listed.
NCT05736731 lists 8 locations in 7 states (California, Arizona, Florida).
Frequently Asked Questions
What is clinical trial NCT05736731 about?
NCT05736731 is a clinical study titled "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". 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 ...
What is the current status of trial NCT05736731?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 160 participants. The study started on 2023-04-28. Estimated completion is 2026-12.
What conditions does trial NCT05736731 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Pancreatic Cancer, Solid Tumor, Solid Tumor, Adult, NSCLC.
What interventions are being tested in trial NCT05736731?
The interventions under investigation include: A2B530 (BIOLOGICAL), xT-Onco with HLA-LOH Assay (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05736731?
This trial is sponsored by A2 Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05736731 being conducted?
This trial has 8 study locations across Arizona, California, Florida, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05736731's enrollment target sits among peer trials
160 192nd of 454 higher than 262 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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