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

An Observational Study Obtaining Solid Tumor Tissue From Participants and Apheresis for CAR T-Cell Therapy Manufacturing

Observational A2 Biotherapeutics Inc. · NCT04981119

This study is testing how often solid tumors lose a key protein that helps the immune system recognize them, while also collecting T cells from patients with high-risk cancers to prepare for future CAR T-cell therapy.

Quick facts

Study typeObservational
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorA2 Biotherapeutics Inc. Industry-sponsored
Drugs / interventionschemotherapy, CAR T
Locations16 sites (Gilbert, Arizona and 15 other locations)
Trial IDNCT04981119 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults with pathologically confirmed metastatic or unresectable solid tumors at high risk for relapse.

Not a fit: Patients with a history of certain other malignancies or prior stem cell or solid organ transplants may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to personalized CAR T-cell therapies for patients with solid tumors, improving treatment outcomes.

How similar studies have performed: While the approach of analyzing HLA loss in tumors is gaining interest, this specific methodology of combining HLA analysis with apheresis for CAR T-cell therapy is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Gilbert, Arizona and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid Tumor, AdultColorectal CancerNon Small Cell Lung CancerPancreatic CancerCRCNSCLCPancreas CancerMesothelioma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.