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Fast tumoranalyse for HLA-tab af heterozygositet (LOH) og leukaferese til CAR T-cellefremstilling (BASECAMP-1)

22. oktober 2026 opdateret af: A2 Biotherapeutics Inc.

En observationsundersøgelse, der opnår fast tumorvæv fra forsøgspersoner med primær kirurgisk resektion og leukaferese til fremstilling af CAR T-celleterapi

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Background:

Human Leukocyte Antigen (HLA) is a protein on the outside of cells that allows the immune system to recognize it's own cells as normal and leave them alone or respond if infected with a virus or bacteria, or a tumor cell. HLA might not be expressed normally on cancer cells. This may be why cancer can grow undetected by the immune system and is referred to as a tumor escape mechanism. Tumor escape can occur for many reasons, but one reason is Loss of Heterozygosity (LOH). LOH is the loss of one of the genes that encodes HLA protein. A2 Biotherapeutics, Inc. (A2 Bio) is developing therapies to recognize, target, and kill cancer cells that do not express HLA normally, and minimize any damage to normal cells that express normal HLA.

Once participants are identified as having LOH on their tumors, apheresis, a procedure to separate and collect white blood cells will be performed. It is the first required step in manufacturing CAR T-cell therapy. The collected T cells will be stored for patients that are likely to benefit from CAR T-cell therapy during their disease care.

Study Design:

Approximately 3000 participants will be screened for part 1 of the study, including HLA typing, approximately 1500 participants will have NGS testing on their tumor samples and be followed for up to 2 years on the study, and up to 500 participants will be screened for part 2 of the study and enrolled if eligible and apheresed and be followed for up to 2 years on the study.

Participants will be screened (Part 1) for HLA type, and based on results, participants will have archived tumor tissue tested by next generation sequencing (NGS) and be followed for up to 2 years. Based on the tumor NGS results, participants may be apheresed (Part 2) for Peripheral Blood Mononuclear Cell (PBMC) collection to store their T cells for a future interventional study upon relapse.

Each participant will proceed through the following study periods:

  • Screening (Part 1 and 2)
  • Enrollment (Apheresis)
  • Post Apheresis safety follow-up (Day 7)
  • Two-year long term follow-up

Undersøgelsestype

Observationel

Tilmelding (Anslået)

500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Arizona
      • Gilbert, Arizona, Forenede Stater, 85234
        • Rekruttering
        • Banner Health
        • Ledende efterforsker:
          • Matthew Ulrickson, MD
        • Kontakt:
      • Phoenix, Arizona, Forenede Stater, 85054
        • Rekruttering
        • Mayo Clinic Hospital
        • Kontakt:
          • Clinical Trials Referral Office
          • Telefonnummer: 855-776-0015
        • Ledende efterforsker:
          • Antonious Hazim, MD
    • California
      • Duarte, California, Forenede Stater, 90101
        • Afsluttet
        • City of Hope
      • La Jolla, California, Forenede Stater, 92093
        • Rekruttering
        • University of California San Diego
        • Ledende efterforsker:
          • Sandip Patel, MD
        • Kontakt:
      • Palo Alto, California, Forenede Stater, 94304
        • Rekruttering
        • Stanford University
        • Kontakt:
        • Ledende efterforsker:
          • Wen-Kai Weng, MD
      • Santa Monica, California, Forenede Stater, 90404
        • Rekruttering
        • UCLA Medical Center
        • Ledende efterforsker:
          • J. Randolph Hecht, MD
        • Underforsker:
          • Edward Garon, MD
        • Kontakt:
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32224
        • Rekruttering
        • Mayo Clinic Jacksonville
        • Kontakt:
        • Ledende efterforsker:
          • Yanyan Lou, MD, PhD
      • Tampa, Florida, Forenede Stater, 33136
        • Rekruttering
        • Moffitt Cancer Center
        • Underforsker:
          • Frederick Locke, MD
        • Ledende efterforsker:
          • Kedar Kirtane, MD
        • Kontakt:
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Afsluttet
        • Massachusetts General Hospital/Dana Farber Cancer Institute
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Rekruttering
        • Mayo Clinic Rochester
        • Ledende efterforsker:
          • Julian Molina, MD, PhD
        • Underforsker:
          • Yi Lin, MD, PhD
        • Kontakt:
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Rekruttering
        • Washington University
        • Ledende efterforsker:
          • Patrick Grierson, MD, PhD
        • Kontakt:
    • New York
      • New York, New York, Forenede Stater, 10016
        • Rekruttering
        • NYU Langone Medical Center
        • Ledende efterforsker:
          • Kristen Spencer, DO
        • Kontakt:
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Rekruttering
        • The Ohio State University Comprehensive Cancer Center
        • Kontakt:
        • Ledende efterforsker:
          • Jinesh Gheeya, MD, PhD
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Rekruttering
        • Vanderbilt University Medical Center
        • Kontakt:
          • Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO)
          • Telefonnummer: 1-800-811-8480
          • E-mail: CTIP@VUMC.ORG
        • Ledende efterforsker:
          • Cathy Eng, M.D., FACP, FASCO
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Afsluttet
        • MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
        • Rekruttering
        • Fred Hutchinson Cancer Center
        • Ledende efterforsker:
          • Jennifer Specht, MD
        • Kontakt:
          • Shelby Colden
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Participants with 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, germline HLA-A*02 heterozygous, and have confirmed somatic LOH.

Beskrivelse

Key Eligibility Criteria (additional criteria may apply) Part 1 Key Inclusion Criteria

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.

Part 1: Key Exclusion Criteria

  1. History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.
  2. Prior allogeneic stem cell transplant.
  3. Prior solid organ transplant.

Part 2 : Key Inclusion Criteria

  1. 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.
  2. Participants are germline HLA-A*02 heterozygous confirmed by HLA typing.
  3. Primary tumor tissue showing LOH of HLA-A*02 by NGS testing.
  4. Eastern Cooperative Oncology Group (ECOG) 0 or 1 performance status.

Part 2: Key Exclusion Criteria

  1. History of any of other malignancy in the past 5 years other than non-melanoma skin carcinoma, low grade localized prostate cancer, superficial bladder cancer, ductal carcinoma in situ (CIS) of the breast, CIS of the Cervix, or Stage I uterine cancer.
  2. Prior allogeneic stem cell transplant.
  3. Prior solid organ transplant.
  4. Participants who have received any cancer therapy on any investigational therapy for any indication, including but not limited to chemotherapy, small molecules, monoclonal antibodies, or radiotherapy (with bone marrow impact) within 2 weeks of planned apheresis or 3 half-lives, whichever is shorter.
  5. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment necessitating specific treatment, or any major episode of infection requiring treatment with Intravenous (IV) antimicrobials (e.g., IV antibiotics) or hospitalization (relating to completion of antibiotic course).
  6. Has known active central nervous system metastases. Subjects with previously treated brain metastases may participate upon medical monitor agreement.
  7. In the Investigator's judgement, any other condition or reason the subject would not complete the required study visits and procedures, and follow up visits, or comply with the study requirements for participation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of participants who can enroll in an A2 Biotherapeutics, Inc. CAR T-cell therapy study after undergoing apheresis
Tidsramme: up to 2 years

Participants will be followed for their status of enrollment on an A2 Biotherapeutics, Inc. interventional study
up to 2 years
Percentage of screened participants experiencing loss of heterozygosity (LOH) of HLA-A*02 identified by next generation sequencing
Tidsramme: Screening

Percentage of participants experiencing LOH will be calculated based on NGS results
Screening

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of enrolled participants who experience an adverse event (AE) related to apheresis
Tidsramme: 7 days

Adverse events will be collected and monitored for relatedness to apheresis during the course of the study
7 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

A2 Biotherapeutics Inc.

Samarbejdspartnere

Tempus AI

Efterforskere

  • Studieleder: Eric W Ng, MD, FAAP, A2 Biotherapeutics Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. oktober 2021

Primær færdiggørelse (Anslået)

1. december 2028

Studieafslutning (Anslået)

1. april 2029

Datoer for studieregistrering

Først indsendt

19. juli 2021

Først indsendt, der opfyldte QC-kriterier

27. juli 2021

Først opslået (Faktiske)

28. juli 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. oktober 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A2B101-101

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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