Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell 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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 26, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Observational
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- A2 Biotherapeutics Inc.
- Interventions being studied
- Other: Apheresis; Diagnostic Test: Next Generation Sequencing (NGS); Diagnostic Test: Long Range NGS HLA typing
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
Key Eligibility Criteria (additional criteria may apply) Part 1 Key 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
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Banner HealthGilbert, Arizona
- Mayo Clinic HospitalPhoenix, Arizona
- City of HopeDuarte, California
- University of California San DiegoLa Jolla, California
- Stanford UniversityPalo Alto, California
- UCLA Medical CenterSanta Monica, California
- Mayo Clinic JacksonvilleJacksonville, Florida
- Moffitt Cancer CenterTampa, Florida
- Massachusetts General Hospital/Dana Farber Cancer InstituteBoston, Massachusetts
- Mayo Clinic RochesterRochester, Minnesota
- Washington UniversitySt Louis, Missouri
- NYU Langone Medical CenterNew York, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 26, 2026. Always confirm current availability with the study team.