A2B395 for Non-Small Cell Lung Cancer (DENALI-1 Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by A2 Biotherapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\*02 by NGS (whenever possible from the primary site).

2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, HNSCC, TNBC, RCC, or other solid tumors with EGFR expression. Measurable disease is required with lesions of ≥1.0 cm by CT.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of informed consent until 24 months (2 years) post a2b395 infusion

Awards & highlights

No Placebo-Only Group

Summary

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 * A2B395 Tmod CAR T cells at the assigned dose

Who is the study for?

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.

What is being tested?

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).

What are the potential side effects?

While specific side effects aren't listed here, CAR T-cell therapies often cause immune system reactions like fever or fatigue, potential nerve damage symptoms such as confusion or seizures, and could affect blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of informed consent until 24 months (2 years) post a2b395 infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of informed consent until 24 months (2 years) post a2b395 infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of informed consent until 24 months (2 years) post a2b395 infusion for reporting.