Recruiting

CAR T-Cell

Sponsor:

A2 Biotherapeutics Inc.

Code:

NCT04981119

Conditions

Solid Tumor, Adult

Colorectal Cancer

Non Small Cell Lung Cancer

Pancreatic Cancer

CRC

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Apheresis

Next Generation Sequencing (NGS)

Long Range NGS HLA typing

Study Details

Brief summary:

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.

Conditions

Solid Tumor, Adult

Colorectal Cancer

Non Small Cell Lung Cancer

Pancreatic Cancer

CRC

Study ID

NCT04981119

Start date

Oct 29, 2021

Status verified date

Sep, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

1. 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.
2. Prior allogeneic stem cell transplant.
3. Prior solid organ transplant.

Part 2 : Key Inclusion Criteria

1. 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.
2. Participants are germline HLA-A\*02 heterozygous confirmed by HLA typing.
3. Primary tumor tissue showing LOH of HLA-A\*02 by NGS testing.
4. Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status.

Part 2: Key Exclusion Criteria

1. 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.
2. Prior allogeneic stem cell transplant.
3. Prior solid organ transplant.
4. 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.
5. 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).
6. Has known active central nervous system metastases. Subjects with previously treated brain metastases may participate upon medical monitor agreement.
7. 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 Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Interventions

Apheresis

Apheresis procedure performed for collection of PBMCs.

Next Generation Sequencing (NGS)

NGS on tumor tissue and a matched normal sample for loss of heterozygosity in tumor tissue and tumor tissue markers.

Long Range NGS HLA typing

Long range NGS on whole blood to determine germline HLA type.

Primary outcome measure

  • 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 ]
  • Percentage of screened participants experiencing loss of heterozygosity (LOH) of HLA-A*02 identified by next generation sequencing [ Time Frame: Screening ]

Central Contacts and Locations

Central contacts

Locations

Banner Health

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Principal Investigator:

Matthew Ulrickson, MD

Mayo Clinic Hospital

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Clinical Trials Referral Office

855-776-0015

Principal Investigator:

Antonious Hazim, MD

University of California San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Principal Investigator:

Sandip Patel, MD

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Principal Investigator:

Wen-Kai Weng, MD

UCLA Medical Center

Recruiting

Santa Monica, California, United States, 90404

Contacts

Principal Investigator:

J. Randolph Hecht, MD

Mayo Clinic Jacksonville

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Principal Investigator:

Yanyan Lou, MD, PhD

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33136

Contacts

Principal Investigator:

Kedar Kirtane, MD

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Julian Molina, MD, PhD

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Hussain Hassan

hahassan@wustl.edu

Principal Investigator:

Patrick Grierson, MD, PhD

NYU Langone Medical Center

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Kristen Spencer, DO

The Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Jinesh Gheeya, MD, PhD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO)

1-800-811-8480CTIP@VUMC.ORG

Principal Investigator:

Cathy Eng, M.D., FACP, FASCO

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Principal Investigator:

Jennifer Specht, MD

More Information

Sponsor

A2 Biotherapeutics Inc.

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

  • CAR T Cell Therapy
  • Next Generation Sequencing
  • Leukapheresis
  • Apheresis
  • Immunotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by A2 Biotherapeutics Inc. on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.