Life sciences · Observational Study
ClinicalTrials.gov · October 26, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT04981119). This is a study registration, not published results. Lead sponsor: A2 Biotherapeutics Inc.. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 500 participants (ESTIMATED). Conditions: Solid Tumor, Adult, Colorectal Cancer, Non Small Cell Lung Cancer, Pancreatic Cancer, CRC, NSCLC, Pancreas Cancer, Mesothelioma, Ovarian Cancer, Ovarian Neoplasms, Ovarian Carcinoma, Mesothelioma, Malignant, Mesothelioma; Lung, Cancer, Triple Negative Breast Cancer (TNBC), Renal Cell Carcinoma (Kidney Cancer), Head and Neck Squamous Cell Carcinoma HNSCC. Interventions: OTHER: Apheresis; DIAGNOSTIC_TEST: Next Generation Sequencing (NGS); DIAGNOSTIC_TEST: Long Range NGS HLA typing. Primary outcome measures: Percentage of participants who can enroll in an A2 Biotherapeutics, Inc. CAR T-cell therapy study after undergoing apheresis , up to 2 years; Percentage of screened participants experiencing loss of heterozygosity (LOH) of HLA-A*02 identified by next generation sequencing , Screening. Brief summary: 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.