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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
A2 Biotherapeutics Inc.
Study ID
NCT04981119
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apheresis — OTHER
    Apheresis procedure performed for collection of PBMCs.
  • Next Generation Sequencing (NGS) — DIAGNOSTIC_TEST
    NGS on tumor tissue and a matched normal sample for loss of heterozygosity in tumor tissue and tumor tissue markers.
  • Long Range NGS HLA typing — DIAGNOSTIC_TEST
    Long range NGS on whole blood to determine germline HLA type.

Study Details

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.

Key Dates

Start date
Oct 29, 2021
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
200 participants (estimated)

Primary Outcome Measure

Percentage of participants who can enroll in an A2 Biotherapeutics, Inc. CAR T-cell therapy study after undergoing apheresis [ Time Frame: up to 2 years ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
Banner HealthGilbertArizona85234
Jace Luzania
[email protected]
480-256-5483
Matthew Ulrickson, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic HospitalPhoenixArizona85054
Clinical Trials Referral Office
855-776-0015
Antonious Hazim, MD (PRINCIPAL_INVESTIGATOR)
City of HopeDuarteCalifornia90101-
University of California San DiegoLa JollaCalifornia92093
Anthony Oshmago
[email protected]
Sandip Patel, MD (PRINCIPAL_INVESTIGATOR)
Stanford UniversityPalo AltoCalifornia94304
Vivian Leung
[email protected]
Wen-Kai Weng, MD (PRINCIPAL_INVESTIGATOR)
UCLA Medical CenterSanta MonicaCalifornia90404
Karla Largaespada
[email protected]
J. Randolph Hecht, MD (PRINCIPAL_INVESTIGATOR)
Edward Garon, MD (SUB_INVESTIGATOR)
Mayo Clinic JacksonvilleJacksonvilleFlorida32224
Rhoda Romain
[email protected]
Yanyan Lou, MD, PhD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33136
Kedar Kirtane, MD (PRINCIPAL_INVESTIGATOR)
Frederick Locke, MD (SUB_INVESTIGATOR)
Massachusetts General Hospital/Dana Farber Cancer InstituteBostonMassachusetts02114-
Mayo Clinic RochesterRochesterMinnesota55905
Ethan Sunsvold
[email protected]
Julian Molina, MD, PhD (PRINCIPAL_INVESTIGATOR)
Yi Lin, MD, PhD (SUB_INVESTIGATOR)
Washington UniversitySt LouisMissouri63110
Hussain Hassan
[email protected]
Patrick Grierson, MD, PhD (PRINCIPAL_INVESTIGATOR)
NYU Langone Medical CenterNew YorkNew York10016
Kennedi Rainey
[email protected]
Kristen Spencer, DO (PRINCIPAL_INVESTIGATOR)
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Dudbeth Brown
[email protected]
614-685-7034
Jinesh Gheeya, MD, PhD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO)
[email protected]
1-800-811-8480
Cathy Eng, M.D., FACP, FASCO (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030-
Fred Hutchinson Cancer CenterSeattleWashington98109
Shelby Colden
[email protected]
Jennifer Specht, MD (PRINCIPAL_INVESTIGATOR)

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