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RECRUITING

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

NCT04981119 · View on ClinicalTrials.gov ↗

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.

Interventions

  • OTHER Apheresis
  • DIAGNOSTIC_TEST Next Generation Sequencing (NGS)
  • DIAGNOSTIC_TEST Long Range NGS HLA typing

Study Locations (16)

California

  • City of Hope — Duarte
  • University of California San Diego — La Jolla
  • Stanford University — Palo Alto
  • UCLA Medical Center — Santa Monica

Arizona

  • Banner Health — Gilbert
  • Mayo Clinic Hospital — Phoenix

Florida

  • Mayo Clinic Jacksonville — Jacksonville
  • Moffitt Cancer Center — Tampa

Massachusetts

  • Massachusetts General Hospital/Dana Farber Cancer Institute — Boston

Minnesota

  • Mayo Clinic Rochester — Rochester

Missouri

  • Washington University — St Louis

New York

  • NYU Langone Medical Center — New York

Ohio

  • The Ohio State University Comprehensive Cancer Center — Columbus

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2021-10-29
Est. Completion 2029-04

Sponsor

A2 Biotherapeutics

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04981119

The ClinicalTrials.gov registry entry for NCT04981119 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is A2 Biotherapeutics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions — of which Apheresis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04981119 reports 16 study locations spanning 11 distinct geographic areas — top geographies include California, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04981119 about?

NCT04981119 is a clinical study titled "Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing". 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. Des...

What is the current status of trial NCT04981119?

This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2021-10-29. Estimated completion is 2029-04.

What conditions does trial NCT04981119 study?

This clinical trial studies the following conditions: Colorectal Cancer, Ovarian Cancer, Pancreatic Cancer, Non Small Cell Lung Cancer, Solid Tumor, Adult. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04981119?

The interventions under investigation include: Apheresis (OTHER), Next Generation Sequencing (NGS) (DIAGNOSTIC_TEST), Long Range NGS HLA typing (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04981119?

This trial is sponsored by A2 Biotherapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04981119 being conducted?

This trial has 16 study locations across Arizona, California, Florida, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial