A2B395 CAR T-Cell Therapy for Colorectal Cancer

(DENALI-1 Trial)

Recruiting at 6 trial locations

Overseen By Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: A2 Biotherapeutics Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 0

240 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\*02 expression. The main questions this study aims to answer are: * Phase 1: What is the recommended dose of A2B395 that is safe for patients * Phase 2: Does the recommended dose of A2B395 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 in BASECAMP-1 (NCT04981119) * Preconditioning lymphodepletion (PCLD) regimen * A2B395 Tmod CAR T cells at the assigned dose

Research Team

John Welch, MD, PhD

Principal Investigator

A2 Biotherapeutics

Eligibility Criteria

This trial is for people with certain solid tumors (like colorectal, lung, breast, kidney cancers) that have a specific protein called EGFR and lack another marker known as HLA-A*02. Details on who can join are not fully provided but typically include meeting health standards and having the type of cancer being studied.

Inclusion Criteria

I am fully active or can carry out light work.

My organs are functioning well.

Life expectancy of ≥3 months

Exclusion Criteria

I haven't had cancer treatment within 3 weeks or before A2B395 infusion.

My condition can be treated with standard therapy aimed at curing, not just easing symptoms.

I have not had radiotherapy in the last 28 days.

Treatment Details

Interventions

• A2B395

Trial Overview The study tests A2B395, an experimental CAR T-cell therapy designed to target cancer cells in patients with specific tumor types. It includes two phases: finding a safe dose (Phase 1) and seeing if this dose can effectively kill tumor cells while sparing healthy ones (Phase 2).

Participant Groups

Group I: A2B395 Experimental Treatment 2 Interventions

Participants receive preconditioning lymphodepletion (PCLD) regimen followed by a single dose of A2B395 intravenously on day 0

Who Is Running the Clinical Trial?

A2 Biotherapeutics Inc.

Lead Sponsor

Trials

5

Recruited

1,200+