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CAR T-cell Therapy

A2B395 CAR T-Cell Therapy for Colorectal 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

ECOG performance status of 0 to 1

Received previous required therapy for the appropriate solid tumor disease as described in the protocol

Must not have

Cancer therapy within 3 weeks or 3 half lives of A2B395 infusion

Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative

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

This trial aims to test a new treatment called A2B395 on patients with various types of solid tumors. The study will determine the safe dosage of A2B395 and evaluate its effectiveness in killing

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

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I am fully active or can carry out light work.

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I have completed the necessary treatment for my solid tumor as outlined.

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I am enrolled in the BASECAMP-1 study and my tests show LOH of HLA-A*02.

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My cancer is advanced, cannot be surgically removed, and shows EGFR expression.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have had a stem cell transplant from a donor.

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I have had a solid organ transplant.

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I haven't had a heart attack or serious heart issues in the last 6 months.

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I am not pregnant or breastfeeding.

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I need extra oxygen at home.

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.