Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Recruiting · NCT04981119 · Observational (researchers observe without assigning treatment) · Lead sponsor: A2 Biotherapeutics Inc.
View the official record on ClinicalTrials.gov →Interventions studied
ApheresisLong Range NGS HLA typingNext Generation Sequencing (NGS)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- \. 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
- 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.
- Prior allogeneic stem cell transplant.
- Prior solid organ transplant.
- Part 2 : Key Inclusion Criteria
- 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.
- Participants are germline HLA-A\*02 heterozygous confirmed by HLA typing.
- Primary tumor tissue showing LOH of HLA-A\*02 by NGS testing.
- Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status.
- Part 2: Key Exclusion Criteria
- 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.
- Prior allogeneic stem cell transplant.
- Prior solid organ transplant.
- 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.
- 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).
- Has known active central nervous system metastases. Subjects with previously treated brain metastases may participate upon medical monitor agreement.
- 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 is running
16 locations listed across 11 US states.
- Banner Health - Gilbert, Arizona, United States
- Mayo Clinic Hospital - Phoenix, Arizona, United States
- City of Hope - Duarte, California, United States
- University of California San Diego - La Jolla, California, United States
- Stanford University - Palo Alto, California, United States
- UCLA Medical Center - Santa Monica, California, United States
- Mayo Clinic Jacksonville - Jacksonville, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Massachusetts General Hospital/Dana Farber Cancer Institute - Boston, Massachusetts, United States
- Mayo Clinic Rochester - Rochester, Minnesota, United States
- Washington University - St Louis, Missouri, United States
- NYU Langone Medical Center - New York, New York, United States
- The Ohio State University Comprehensive Cancer Center - Columbus, Ohio, United States
- Vanderbilt University Medical Center - Nashville, Tennessee, United States
- MD Anderson Cancer Center - Houston, Texas, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States