An Observational Study Obtaining Solid Tumor Tissue From Participants and Apheresis for CAR T-Cell Therapy Manufacturing

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Other, Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

• 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.

Locations
United States
Arizona
Banner Health
RECRUITING
Gilbert
Mayo Clinic Hospital
RECRUITING
Phoenix
California
City of Hope
COMPLETED
Duarte
University of California San Diego
RECRUITING
La Jolla
Stanford University
RECRUITING
Palo Alto
UCLA Medical Center
RECRUITING
Santa Monica
Florida
Mayo Clinic Jacksonville
RECRUITING
Jacksonville
Moffitt Cancer Center
RECRUITING
Tampa
Massachusetts
Massachusetts General Hospital/Dana Farber Cancer Institute
ACTIVE_NOT_RECRUITING
Boston
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Missouri
Washington University
RECRUITING
St Louis
New York
NYU Langone Medical Center
RECRUITING
New York
Ohio
The Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Texas
MD Anderson Cancer Center
ACTIVE_NOT_RECRUITING
Houston
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Contact Information
Primary
Clinical Trials
ClinicalTrials@a2bio.com
(310)431-9180
Time Frame
Start Date: 2021-10-29
Estimated Completion Date: 2026-12
Participants
Target number of participants: 200
Authors
Sponsors
Leads: A2 Biotherapeutics Inc.
Collaborators: Tempus AI

This content was sourced from clinicaltrials.gov

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