Actively Recruiting
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Led by A2 Biotherapeutics Inc. · Updated on 2026-04-30
200
Participants Needed
16
Research Sites
387 weeks
Total Duration
On this page
Sponsors
A
A2 Biotherapeutics Inc.
Lead Sponsor
T
Tempus AI
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with pathologically confirmed solid tumors such as colorectal cancer, non-small cell lung cancer, pancreatic cancer, mesothelioma, or ovarian cancer
- Tumors must be metastatic, unresectable locally advanced, or considered high risk for incurable relapse within two years
- Germline HLA-A*02 heterozygous confirmed by HLA typing
- Primary tumor tissue shows loss of heterozygosity of HLA-A*02 by next generation sequencing
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You will not qualify if you...
- History of other malignancy in the past 5 years except non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ of the breast or cervix, or Stage I uterine cancer
- Prior allogeneic stem cell transplant
- Prior solid organ transplant
- Received any cancer therapy including chemotherapy, small molecules, monoclonal antibodies, or radiotherapy with bone marrow impact within 2 weeks or 3 half-lives before planned apheresis
- Known active infection requiring specific treatment or major infection requiring intravenous antimicrobials or hospitalization
- Known active central nervous system metastases (previously treated brain metastases may be allowed with medical monitor approval)
- Any other condition that would prevent completing study visits, procedures, follow-up, or compliance as judged by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Banner Health
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Actively Recruiting
3
City of Hope
Duarte, California, United States, 90101
Completed
4
University of California San Diego
La Jolla, California, United States, 92093
Actively Recruiting
5
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
6
UCLA Medical Center
Santa Monica, California, United States, 90404
Actively Recruiting
7
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
8
Moffitt Cancer Center
Tampa, Florida, United States, 33136
Actively Recruiting
9
Massachusetts General Hospital/Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02114
Completed
10
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
11
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
12
NYU Langone Medical Center
New York, New York, United States, 10016
Actively Recruiting
13
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
14
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
15
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Completed
16
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
C
Clinical Trials
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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