Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing (BASECAMP-1)

September 1, 2026 updated by: A2 Biotherapeutics Inc.

An Observational Study Obtaining Solid Tumor Tissue From Participants and Apheresis for CAR T-Cell Therapy Manufacturing

Objective:

To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment.

Design:

This is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

Human Leukocyte Antigen (HLA) is a protein on the outside of cells that allows the immune system to recognize it's own cells as normal and leave them alone or respond if infected with a virus or bacteria, or a tumor cell. HLA might not be expressed normally on cancer cells. This may be why cancer can grow undetected by the immune system and is referred to as a tumor escape mechanism. Tumor escape can occur for many reasons, but one reason is Loss of Heterozygosity (LOH). LOH is the loss of one of the genes that encodes HLA protein. A2 Biotherapeutics, Inc. (A2 Bio) is developing therapies to recognize, target, and kill cancer cells that do not express HLA normally, and minimize any damage to normal cells that express normal HLA.

Once participants are identified as having LOH on their tumors, apheresis, a procedure to separate and collect white blood cells will be performed. It is the first required step in manufacturing CAR T-cell therapy. The collected T cells will be stored for patients that are likely to benefit from CAR T-cell therapy during their disease care.

Study Design:

Approximately 3000 participants will be screened for part 1 of the study, including HLA typing, approximately 1500 participants will have NGS testing on their tumor samples and be followed for up to 2 years on the study, and up to 500 participants will be screened for part 2 of the study and enrolled if eligible and apheresed and be followed for up to 2 years on the study.

Participants will be screened (Part 1) for HLA type, and based on results, participants will have archived tumor tissue tested by next generation sequencing (NGS) and be followed for up to 2 years. Based on the tumor NGS results, participants may be apheresed (Part 2) for Peripheral Blood Mononuclear Cell (PBMC) collection to store their T cells for a future interventional study upon relapse.

Each participant will proceed through the following study periods:

Screening (Part 1 and 2)
Enrollment (Apheresis)
Post Apheresis safety follow-up (Day 7)
Two-year long term follow-up

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Clinical Trials
Phone Number: (310)431-9180
Email: ClinicalTrials@a2bio.com

Study Locations

United States
- Arizona
  - Gilbert, Arizona, United States, 85234
    - Recruiting
    - Banner Health
    - Principal Investigator:
      
      Matthew Ulrickson, MD
    - Contact:
      
      Jace Luzania
      
      Phone Number: 480-256-5483
      
      Email: Jace.Luzania@bannerhealth.com
  - Phoenix, Arizona, United States, 85054
    - Recruiting
    - Mayo Clinic Hospital
    - Contact:
      
      Clinical Trials Referral Office
      
      Phone Number: 855-776-0015
    - Principal Investigator:
      
      Antonious Hazim, MD
- California
  - Duarte, California, United States, 90101
    - Completed
    - City of Hope
  - La Jolla, California, United States, 92093
    - Recruiting
    - University of California San Diego
    - Principal Investigator:
      
      Sandip Patel, MD
    - Contact:
      
      Anthony Oshmago
      
      Email: aoshmago@health.ucsd.edu
  - Palo Alto, California, United States, 94304
    - Recruiting
    - Stanford University
    - Contact:
      
      Vivian Leung
      
      Email: vivian0@stanford.edu
    - Principal Investigator:
      
      Wen-Kai Weng, MD
  - Santa Monica, California, United States, 90404
    - Recruiting
    - UCLA Medical Center
    - Principal Investigator:
      
      J. Randolph Hecht, MD
    - Sub-Investigator:
      
      Edward Garon, MD
    - Contact:
      
      Karla Largaespada
      
      Email: KLargaespada@mednet.ucla.edu
- Florida
  - Jacksonville, Florida, United States, 32224
    - Recruiting
    - Mayo Clinic Jacksonville
    - Contact:
      
      Rhoda Romain
      
      Email: Romain.Rhoda@mayo.edu
    - Principal Investigator:
      
      Yanyan Lou, MD, PhD
  - Tampa, Florida, United States, 33136
    - Recruiting
    - Moffitt Cancer Center
    - Sub-Investigator:
      
      Frederick Locke, MD
    - Principal Investigator:
      
      Kedar Kirtane, MD
    - Contact:
      
      Katie Ehm
      
      Email: Katie.Ehm@moffitt.org
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Completed
    - Massachusetts General Hospital/Dana Farber Cancer Institute
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - Mayo Clinic Rochester
    - Principal Investigator:
      
      Julian Molina, MD, PhD
    - Sub-Investigator:
      
      Yi Lin, MD, PhD
    - Contact:
      
      Ethan Sundsvold
      
      Email: Sundsvold.Ethan@mayo.edu
- Missouri
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - Washington University
    - Principal Investigator:
      
      Patrick Grierson, MD, PhD
    - Contact:
      
      Hussain Hassan
      
      Email: hahassan@wustl.edu
- New York
  - New York, New York, United States, 10016
    - Recruiting
    - NYU Langone Medical Center
    - Principal Investigator:
      
      Kristen Spencer, DO
    - Contact:
      
      Kennedi Rainey
      
      Email: Kennedi.Rainey@nyulangone.org
- Ohio
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - The Ohio State University Comprehensive Cancer Center
    - Contact:
      
      Dudbeth Brown
      
      Phone Number: 614-685-7034
      
      Email: Dudbeth.Brown@osumc.edu
    - Principal Investigator:
      
      Jinesh Gheeya, MD, PhD
- Tennessee
  - Nashville, Tennessee, United States, 37232
    - Recruiting
    - Vanderbilt University Medical Center
    - Contact:
      
      Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO)
      
      Phone Number: 1-800-811-8480
      
      Email: CTIP@VUMC.ORG
    - Principal Investigator:
      
      Cathy Eng, M.D., FACP, FASCO
- Texas
  - Houston, Texas, United States, 77030
    - Completed
    - MD Anderson Cancer Center
- Washington
  - Seattle, Washington, United States, 98109
    - Recruiting
    - Fred Hutchinson Cancer Center
    - Principal Investigator:
      
      Jennifer Specht, MD
    - Contact:
      
      Shelby Colden
    - Contact:
      
      Email: scolden2@fredhutch.org

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Participants with Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer (PANC), mesothelioma, or Ovarian Cancer (OVAC) that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years, germline HLA-A*02 heterozygous, and have confirmed somatic LOH.

Description

Key Eligibility Criteria (additional criteria may apply) Part 1 Key Inclusion Criteria

1. Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), or Pancreatic Cancer (PANC), that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years.

Part 1: Key Exclusion Criteria

History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.
Prior allogeneic stem cell transplant.
Prior solid organ transplant.

Part 2 : Key Inclusion Criteria

Pathologically confirmed solid tumors, e.g., Colorectal Cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer (PANC), Mesothelioma, or Ovarian Cancer (OVAC) that is metastatic, unresectable locally advanced, or in the Investigator's opinion the subject is high risk for incurable relapse within two years.
Participants are germline HLA-A*02 heterozygous confirmed by HLA typing.
Primary tumor tissue showing LOH of HLA-A*02 by NGS testing.
Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status.

Part 2: Key Exclusion Criteria

History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.
Prior allogeneic stem cell transplant.
Prior solid organ transplant.
Participants who have received any cancer therapy on any investigational therapy for any indication, including but not limited to chemotherapy, small molecules, monoclonal antibodies, or radiotherapy (with bone marrow impact) within 2 weeks of planned apheresis or 3 half-lives, whichever is shorter.
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment necessitating specific treatment, or any major episode of infection requiring treatment with Intravenous (IV) antimicrobials (e.g., IV antibiotics) or hospitalization (relating to completion of antibiotic course).
Has known active central nervous system metastases. Subjects with previously treated brain metastases may participate upon medical monitor agreement.
In the Investigator's judgement, any other condition or reason the subject would not complete the required study visits and procedures, and follow up visits, or comply with the study requirements for participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants who can enroll in an A2 Biotherapeutics, Inc. CAR T-cell therapy study after undergoing apheresis Time Frame: up to 2 years	Participants will be followed for their status of enrollment on an A2 Biotherapeutics, Inc. interventional study	up to 2 years
Percentage of screened participants experiencing loss of heterozygosity (LOH) of HLA-A*02 identified by next generation sequencing Time Frame: Screening	Percentage of participants experiencing LOH will be calculated based on NGS results	Screening

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of enrolled participants who experience an adverse event (AE) related to apheresis Time Frame: 7 days	Adverse events will be collected and monitored for relatedness to apheresis during the course of the study	7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A2 Biotherapeutics Inc.

Collaborators

Tempus AI

Investigators

Study Director: Eric W Ng, MD, FAAP, A2 Biotherapeutics Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

A2 Bio website

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 29, 2021

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

July 19, 2021

First Submitted That Met QC Criteria

July 27, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified