Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Leukapheresis for CAR T- Cell Manufacturing (BASECAMP-1)
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|ClinicalTrials.gov Identifier: NCT04981119|
Recruitment Status : Recruiting
First Posted : July 28, 2021
Last Update Posted : September 8, 2022
To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform leukapheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment.
This is a non-interventional, observational study to evaluate subjects 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.
|Condition or disease||Intervention/treatment|
|Solid Tumor, Adult Colorectal Cancer Non Small Cell Lung Cancer Pancreatic Cancer CRC NSCLC Pancreas Cancer||Other: Leukapheresis Diagnostic Test: Next Generation Sequencing (NGS) Diagnostic Test: Long Range NGS HLA typing|
Human Leukocyte Antigen (HLA) is a protein on the outside of cells that allows the immune system to recognize it's own cells as normal and leave them alone or respond if infected with a virus or bacteria, or a tumor cell. HLA might not be expressed normally on cancer cells. This may be why cancer can grow undetected by the immune system and is referred to as a tumor escape mechanism. Tumor escape can occur for many reasons, but one reason is Loss of Heterozygosity (LOH). LOH is the loss of one of the genes that encodes HLA protein. A2 Biotherapeutics, Inc. (A2 Bio) is developing therapies to recognize, target, and kill cancer cells that do not express HLA normally, and minimize any damage to normal cells that express normal HLA.
Once participants are identified as having LOH on their tumors, leukapheresis, a procedure to separate and collect white blood cells will be performed. It is the first required step in manufacturing CAR T-cell therapy. The collected T cells will be stored for patients that are likely to benefit from CAR T-cell therapy during their disease care.
Approximately 1000 participants will be screened for part 1 of the study, including HLA typing, approximately 500 participants will have NGS testing on their tumor samples and be followed for up to 2 years on the study, and up to 200 participants will be screened for part 2 of the study and enrolled if eligible and leukapheresed and be followed for up to 2 years on the study.
Participants will be screened (Part 1) for HLA type, and based on results, participants will have archived tumor tissue tested by next generation sequencing (NGS) and be followed for up to 2 years. Based on the tumor NGS results, participants will be leukapheresed (Part 2) for Peripheral Blood Mononuclear Cell (PBMC) collection to store their T cells for a future interventional study upon relapse.
Each participant will proceed through the following study periods:
- Screening (Part 1 and 2)
- Enrollment (Leukapheresis)
- Post Leukapheresis safety follow-up (Day 7)
- Two-year long term follow-up
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||An Observational Study Obtaining Solid Tumor Tissue From Subjects With Primary Surgical Resection and Leukapheresis for CAR T-Cell Therapy Manufacturing|
|Actual Study Start Date :||October 29, 2021|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2026|
- Other: Leukapheresis
Leukapheresis procedure performed for collection of PBMCs.
- Diagnostic Test: Next Generation Sequencing (NGS)
NGS on tumor tissue and a matched normal sample for loss of heterozygosity in tumor tissue and tumor tissue markers.
- Diagnostic Test: Long Range NGS HLA typing
Long range NGS on whole blood to determine germline HLA type.
- Percentage of participants who can enroll in an A2 Biotherapeutics, Inc. CAR T-cell therapy study after undergoing leukapheresis. [ Time Frame: up to 2 years ]Participants will be followed for their status of enrollment on an A2 Biotherapeutics, Inc. interventional study.
- Percentage of screened participants experiencing loss of heterozygosity (LOH) of HLA-A*02 identified by next generation sequencing. [ Time Frame: Screening ]Percentage of participants experiencing LOH will be calculated based on NGS results.
- Percentage of enrolled participants who experience an adverse event (AE) related to leukapheresis. [ Time Frame: 7 days ]Adverse events will be collected and monitored for relatedness to leukapheresis during the course of the study.
Biospecimen Retention: Samples With DNA
Blood and archived tumor tissue samples will be obtained for NGS to determine HLA type and LOH status of tumor tissue. DNA and RNA will be retained for enrolled participants only, if repeat testing if required. No further genetic testing will be performed on these samples.
Peripheral Blood Mononuclear Cells (PBMCs) will be collected for enrolled subjects, enriched for T cells and cryopreserved for future manufacturing of an A2 Biotherapeutics, Inc. CAR T-cell therapy upon participant relapse. No further genetic testing will be performed on this sample.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04981119
|Contact: Kirstin Liechty||(310)431-9180||BASECAMP1@a2bio.com|
|United States, California|
|City of Hope||Recruiting|
|Duarte, California, United States, 90101|
|Contact: Ripa Martirosyan firstname.lastname@example.org|
|Principal Investigator: Marwan Fakih, MD|
|University of California San Diego||Recruiting|
|La Jolla, California, United States, 92093|
|Contact: Julia Applet email@example.com|
|Principal Investigator: Sandip Patel, MD|
|UCLA Medical Center||Recruiting|
|Santa Monica, California, United States, 90404|
|Contact: Chris Hannigan CHannigan@mednet.ucla.edu|
|Principal Investigator: J. Randolph Hecht, MD|
|Sub-Investigator: Edward Garon, MD|
|United States, Florida|
|Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33136|
|Contact: Lauren Reagan Lauren.Reagan@moffitt.org|
|Principal Investigator: Kedar Kirtane, MD|
|United States, Minnesota|
|Mayo Clinic Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Janet Lensing firstname.lastname@example.org|
|Principal Investigator: Julian Molina, MD, PhD|
|Sub-Investigator: Yi Lin, MD, PhD|
|United States, New York|
|NYU Langone Medical Center||Recruiting|
|New York, New York, United States, 10016|
|Contact: Tate Chan Tate.Chan@nyulangone.org|
|Principal Investigator: Diane Simeone, MD|
|Sub-Investigator: Theodore Welling, MD|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Kimberly Ross 713-632-5909 email@example.com|
|Sub-Investigator: Scott Kopetz, MD, PhD|
|Principal Investigator: Maria Pia Morelli, MD, PhD|
|Study Director:||William Go, MD, PhD||A2 Biotherapeutics Inc.|