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A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression

ConditionsSolid Tumor, AdultColorectal CancerNon-Small Cell LungNSCLC (Non-small Cell Lung Cancer)CancerColon CancerRectal CancerLung CancerCRCHead and Neck Squamous Cell CancerHNSCCRenal Cell CarcinomaRCCKidney CancerTriple Negative Breast CancerTNBCColorectal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorA2 Biotherapeutics Inc.

About 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

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.

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

Has adequate organ function as described in the protocol

Disqualifiers

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

Prior allogeneic stem cell transplant

Prior solid organ transplant

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

Trial design

Design model

Single group

Treatments tested in this trial

  • A2B395

    Biological/Vaccine

    Allogeneic logic-gated Tmod CAR T cells

  • xT CDx with HLA-LOH assay

    Diagnostic test

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

Treatment groups

240 Participants
are divided into 1 treatment group
Group A: A2B395Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Phase 1: Rate of adverse events and dose limiting toxicities (DLTs) by dose level

Adverse events and toxicity will be evaluated according to the Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (or current version). Cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and graft versus host disease (GvHD) events will be graded according to the criteria described in the current protocol.

Time frame
From the time of Informed consent until 24 months (2 years) post A2B395 infusion
2

Phase 1: Recommended phase 2 dose (RP2D)

The RP2D will be identified utilizing a BOIN study design in addition to considering safety and biomarker analysis.

Time frame
28 days post A2B395 infusion
3

Phase 2: The overall response rate (ORR) for patients

The ORR will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and assessed by independent central review.

Time frame
24 months post A2B395 infusion

Secondary outcomes

1

Persistence of A2B395

Number of A2B395 Tmod CAR T cells present in participants treated with A2B395 as assessed by polymerase chain reaction (PCR) (or similar method) on participant blood samples

Time frame
up to 24 months post A2B395 infusion
2

Cytokine analysis

Cytokine levels such as interferon-gamma (IFN-γ) in participants treated with A2B395 assessed by cytokine analysis on participant blood samples

Time frame
up to 24 months post A2B395 infusion
3

Cytokine analysis

Cytokine levels such as interleukin-6 (IL-6) in participants treated with A2B395 assessed by cytokine analysis on participant blood samples

Time frame
up to 24 months post A2B395 infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

A2 Biotherapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov
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