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

Launched by A2 BIOTHERAPEUTICS INC. · Jul 27, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring how often certain solid tumors, like colorectal cancer and lung cancer, lose a specific gene marker called Human Leukocyte Antigen (HLA) and how this loss might affect treatment options. The study involves collecting patients' own T cells, a type of immune cell, through a process called apheresis, which is like a blood donation. These collected cells will be stored for potential future use in CAR T-cell therapy, a treatment that helps the immune system fight cancer more effectively if the patient’s cancer comes back.

To be eligible for this study, participants must have a confirmed diagnosis of certain solid tumors that are advanced and difficult to treat, and they must be at high risk for their cancer returning within two years. Other key requirements include having a specific gene type and showing evidence of HLA loss in their tumor tissue. Throughout the trial, participants will not receive any treatment, but they may learn valuable information about their cancer that could help with future management. It's important to know that this study is observational, meaning it will not involve any active treatment during participation.

Gender

ALL

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.