MedTrace Logo

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

NCT04981119 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Apheresis

Apheresis 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.

Sponsors & Collaborators

  • Tempus AI

    collaborator INDUSTRY

  • A2 Biotherapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Eric W Ng, MD, FAAP · A2 Biotherapeutics Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-29
Primary Completion
2028-12-31
Completion
2029-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04981119 on ClinicalTrials.gov