Ovarian Cancer Clinical Trial

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

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.

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Full Description

Background:

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, apheresis, 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.

Study Design:

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 apheresed 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 apheresed (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 (Apheresis)
Post Apheresis safety follow-up (Day 7)
Two-year long term follow-up

View Eligibility Criteria

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

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.

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

200

Study ID:

NCT04981119

Recruitment Status:

Recruiting

Sponsor:

A2 Biotherapeutics Inc.

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There are 13 Locations for this study

See Locations Near You

Banner Health
Gilbert Arizona, 85234, United States More Info
Natasha Tamula
Contact
[email protected]
Matthew Ulrickson, MD
Principal Investigator
City of Hope
Duarte California, 90101, United States More Info
Janela Agonoy
Contact
[email protected]
Marwan Fakih, MD
Principal Investigator
University of California San Diego
La Jolla California, 92093, United States More Info
Jona Plevin
Contact
[email protected]
Sandip Patel, MD
Principal Investigator
Stanford University
Palo Alto California, 94305, United States More Info
Stephanie Rodriguez
Contact
[email protected]
Saurabh Dahiya, MD
Principal Investigator
UCLA Medical Center
Santa Monica California, 90404, United States More Info
Alexa Berezowitz
Contact
[email protected]
J. Randolph Hecht, MD
Principal Investigator
Edward Garon, MD
Sub-Investigator
Mayo Clinic Jacksonville
Jacksonville Florida, 32224, United States More Info
Ridwan Ahmad
Contact
[email protected]
Hermant Murthy, MD
Principal Investigator
Moffitt Cancer Center
Tampa Florida, 33136, United States More Info
Gillian Zankel
Contact
[email protected]
Kedar Kirtane, MD
Principal Investigator
Frederick Locke, MD
Sub-Investigator
Massachusetts General Hospital/Dana Farber Cancer Institute
Boston Massachusetts, 02114, United States More Info
Jong Chul Park, MD
Contact
[email protected]
Jong Chul Park, MD
Principal Investigator
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States More Info
Ethan Sunsvold
Contact
[email protected]
Julian Molina, MD, PhD
Principal Investigator
Yi Lin, MD, PhD
Sub-Investigator
Washington University
Saint Louis Missouri, 63110, United States More Info
Amberly Scott
Contact
[email protected]
Patrick Grierson, MD, PhD
Principal Investigator
NYU Langone Medical Center
New York New York, 10016, United States More Info
Tate Chan
Contact
[email protected]
Diane Simeone, MD
Principal Investigator
Theodore Welling, MD
Sub-Investigator
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Kaitlin Gandy
Contact
713-632-5909
[email protected]
Maria Pia Morelli, MD, PhD
Principal Investigator
Scott Kopetz, MD, PhD
Sub-Investigator
Fred Hutchinson Cancer Center
Seattle Washington, 98109, United States More Info
Dubem Chiedu
Contact
[email protected]
Jennifer Specht, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

200

Study ID:

NCT04981119

Recruitment Status:

Recruiting

Sponsor:


A2 Biotherapeutics Inc.

How clear is this clinincal trial information?

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