Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
An Observational Study Obtaining Solid Tumor Tissue From Participants and Apheresis for CAR T-Cell Therapy Manufacturing
- Solid Tumor, Adult
- Colorectal Cancer
- Non Small Cell Lung Cancer
- Pancreatic Cancer
- CRC
- NSCLC
- Pancreas Cancer
- Mesothelioma
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- A2 Biotherapeutics Inc.
- Enrolment target
- 500
- Started
- 29 October 2021
- Main results due
- December 2028
- Study sites
- 16
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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 sites(16)
Banner Health
Gilbert, Arizona, United States
Recruiting
Mayo Clinic Hospital
Phoenix, Arizona, United States
Recruiting
City of Hope
Duarte, California, United States
Completed
University of California San Diego
La Jolla, California, United States
Recruiting
Stanford University
Palo Alto, California, United States
Recruiting
UCLA Medical Center
Santa Monica, California, United States
Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
Massachusetts General Hospital/Dana Farber Cancer Institute
Boston, Massachusetts, United States
Completed
Mayo Clinic Rochester
Rochester, Minnesota, United States
Recruiting
Washington University
St Louis, Missouri, United States
Recruiting
NYU Langone Medical Center
New York, New York, United States
Recruiting
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Recruiting
MD Anderson Cancer Center
Houston, Texas, United States
Completed
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Recruiting
Showing 16 of 16 sites. 13 of the 16 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT04981119. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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