Analyzing solid tumors for HLA loss and collecting T cells for CAR T-cell therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the frequency of Human Leukocyte Antigen (HLA) loss in solid tumors using next generation sequencing. Participants with high-risk solid tumors, such as colorectal cancer, non-small cell lung cancer, and pancreatic cancer, will be screened and may undergo apheresis to collect their T cells for potential future CAR T-cell therapy. The study will involve approximately 1000 participants, with a focus on understanding tumor escape mechanisms and preparing for personalized immunotherapy. No interventional treatments will be administered during the study.

Why it matters

Who can join: the full rules

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.

Where it's running

• Banner Health
  Gilbert, Arizona, United States Recruiting
• Mayo Clinic Hospital
  Phoenix, Arizona, United States Recruiting
• 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

Study contacts

• Study coordinator: Clinical Trials
• Email: ClinicalTrials@a2bio.com
• Phone: (310)431-9180

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.