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Solid tumoranalyse for HLA-tap av heterozygositet (LOH) og leukaferese for CAR T-celleproduksjon (BASECAMP-1)

22. oktober 2026 oppdatert av: A2 Biotherapeutics Inc.

En observasjonsstudie som oppnår solid svulstvev fra forsøkspersoner med primær kirurgisk reseksjon og leukaferese for produksjon av 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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

Studietype

Observasjonsmessig

Registrering (Antatt)

500

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: COHORT
  • Tidsperspektiver: PROSPECTIVE

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

A2 Biotherapeutics Inc.

Samarbeidspartnere

Tempus AI

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. oktober 2021

Primær fullføring (Antatt)

1. desember 2028

Studiet fullført (Antatt)

1. april 2029

Datoer for studieregistrering

Først innsendt

19. juli 2021

Først innsendt som oppfylte QC-kriteriene

27. juli 2021

Først lagt ut (Faktiske)

28. juli 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. oktober 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • A2B101-101

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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