RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-10-29
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04981119

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Clinical Trials
CONTACT
(310)431-9180
ClinicalTrials@a2bio.com

Principal Investigator

William Go, MD, PhD
STUDY_DIRECTOR
A2 Biotherapeutics Inc.

Study Locations (Sites)

Banner Health
Gilbert, Arizona, 85234
United States
City of Hope
Duarte, California, 90101
United States
University of California San Diego
La Jolla, California, 92093
United States
Stanford University
Palo Alto, California, 94305
United States
UCLA Medical Center
Santa Monica, California, 90404
United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
United States
Moffitt Cancer Center
Tampa, Florida, 33136
United States
Massachusetts General Hospital/Dana Farber Cancer Institute
Boston, Massachusetts, 02114
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
Washington University
Saint Louis, Missouri, 63110
United States
NYU Langone Medical Center
New York, New York, 10016
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: A2 Biotherapeutics Inc.

  • William Go, MD, PhD, STUDY_DIRECTOR, A2 Biotherapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-29
Study Completion Date2026-12

Study Record Updates

Study Start Date2021-10-29
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • CAR T Cell Therapy
  • Next Generation Sequencing
  • Leukapheresis
  • Apheresis
  • Immunotherapy

Additional Relevant MeSH Terms

  • 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