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

Description

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

Conditions

Solid Tumor, Adult, Colorectal Cancer, Non-Small Cell Lung, NSCLC (Non-small Cell Lung Cancer), Cancer, Colon Cancer, Rectal Cancer, Lung Cancer, CRC, Head and Neck Squamous Cell Cancer, HNSCC, Renal Cell Carcinoma, RCC, Kidney Cancer, Triple Negative Breast Cancer, TNBC, Colorectal Adenocarcinoma

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Study Overview

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Study Details

Study overview

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

A Seamless Phase 1/2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression

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

Condition
Solid Tumor, Adult
Intervention / Treatment

-

Contacts and Locations

La Jolla

UCSD Moores Cancer Center, La Jolla, California, United States, 92093

Los Angeles

UCLA Medical Center, Los Angeles, California, United States, 90404

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33606

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Saint Louis

Washington Unversity, Saint Louis, Missouri, United States, 63110

New York

NYU Langone Medical Center, New York, New York, United States, 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative
  • 2. Prior allogeneic stem cell transplant
  • 3. Prior solid organ transplant
  • 4. Cancer therapy within 3 weeks or 3 half lives of A2B395 infusion
  • 5. Radiotherapy within 28 days of A2B395 infusion
  • 6. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months
  • 7. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated
  • 8. History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year
  • 9. Requires supplemental home oxygen
  • 10. Females of childbearing potential who are pregnant or breastfeeding
  • 11. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion of A2B395

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

A2 Biotherapeutics Inc.,

John Welch, MD, PhD, STUDY_DIRECTOR, A2 Biotherapeutics

Study Record Dates

2030-03-31