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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

NCT05736731 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-04-25

No results posted yet for this 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

Conditions

  • Solid Tumor, Adult
  • Solid Tumor
  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • Pancreas Cancer
  • Non Small Cell Lung Cancer
  • Non Small Cell Lung Cancer Recurrent
  • Non-Small Cell Squamous Lung Cancer
  • NSCLC
  • NSCLC, Recurrent
  • Colorectal Cancer
  • Colorectal Neoplasms
  • Colorectal Adenocarcinoma
  • CRC
  • Colorectal Cancer Metastatic
  • Cancer

Interventions

BIOLOGICAL

A2B530

Autologous logic-gated Tmod CAR T-cells

DIAGNOSTIC_TEST

xT-Onco with HLA-LOH Assay

An investigational next generation sequencing (NGS) in vitro diagnostic (IVD) medical device

Sponsors & Collaborators

  • Tempus AI

    collaborator INDUSTRY

  • A2 Biotherapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Ng, MD · A2 Biotherapeutics Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-28
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05736731 on ClinicalTrials.gov