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NCT04981119From ClinicalTrials.govRecruiting

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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Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing | Trialion