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Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE)

18. maj 2026 opdateret af: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

A Phase 2, Multicenter, Open-Label Study of Zolacabtagene Autoleucel (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Chronic Immune Thrombocytopenia (cITP) and Autoimmune Hemolytic Anemia (AIHA)

The purpose of this study is to evaluate the safety and efficacy of Zola-cel (BMS-986353), in participants with chronic immune thrombocytopenia (cITP) and autoimmune hemolytic anemia (AIHA).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

52

Fase

  • Fase 2

Kontakter og lokationer

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

Studiekontakt

  • Navn: First line of the email MUST contain NCT # and Site #.

Undersøgelse Kontakt Backup

  • Navn: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Telefonnummer: 855-907-3286
  • E-mail: Clinical.Trials@bms.com

Studiesteder

  • Danmark
      • Odense, Danmark, DK-5000
        • Local Institution - 201
        • Kontakt:
          • Site 201
  • Det Forenede Kongerige
      • Sheffield, Det Forenede Kongerige, S10 2SJ
        • Local Institution - 402
        • Kontakt:
          • Site 402
    • Greater London
      • London, Greater London, Det Forenede Kongerige, W12 OHS
        • Local Institution - 401
        • Kontakt:
          • Site 401
  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Local Institution - 101
        • Kontakt:
          • Site 101
    • Texas
      • Houston, Texas, Forenede Stater, 77030-2740
        • Local Institution - 103
        • Kontakt:
          • Site 103
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
        • Local Institution - 102
        • Kontakt:
          • Site 102
  • Tyskland
      • Erlangen, Tyskland, 91054
        • Local Institution - 302
        • Kontakt:
          • Site 302
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Tyskland, 39120
        • Local Institution - 301
        • Kontakt:
          • Site 301

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria

Inclusion Criteria for ITP

  • Documented clinical diagnosis of chronic ITP (cITP) without other clinical manifestations of systemic autoimmune disease.
  • Has relapsed after or is intolerant to corticosteroids (with or without intravenous immunoglobulin (IVIG) or anti-Rh0(D) Ig) AND has failed, relapsed after, or is intolerant to therapies with ≥ 2 mechanisms of action, with at least one being immunosuppressive or immunomodulatory.

Platelet count < 30 × 109/L. For participants on thrombopoietin receptor agonist (TPO-RA): platelet count < 50 × 109/L.

Inclusion Criteria for AIHA

  • Documented clinical diagnosis of AIHA (including warm autoimmune hemolytic anemia (wAIHA), cold agglutinin disease (CAD), or mixed AIHA) without other clinical manifestations of systemic autoimmune disease.

    o wAIHA and mixed warm and cold AIHA: Failed, relapsed after, or is intolerant to at least 2 prior lines of treatment with 2 mechanisms of action (not including corticosteroids or IVIG), one of which is an anti-CD20 monoclonal antibody unless there is a documented contraindication.

    o CAD (all of the following must apply): Failed, relapsed after, or is intolerant to at least 2 prior lines of treatment with 2 mechanisms of action, one of which is an anti-CD20 monoclonal antibody with or without chemotherapy unless there is a documented contraindication.

  • Hb <10 g/dL without red blood cell transfusion, or transfusion dependent
  • Documented hemolysis

Exclusion Criteria

Medical Conditions

  • ITP or AIHA associated with: Evans syndrome, other systemic autoimmune disease or single organ autoimmune disease requiring systemic immunosuppressive therapy, hepatitis C virus, HIV, drug induced (eg, non-steroidal anti-inflammatory drug (NSAIDS), trimethoprim/sulfamethoxazole (TMP-SMX), anticonvulsants), surgical procedures, or hematologic malignancies.
  • COVID-19 Vaccine-induced immune thrombotic thrombocytopenia
  • Prior history of solid organ malignancies, unless the participant has been free of the disease for ≥ 2 years.

Laboratory Test Findings

  • Peripheral blood ANC < 1.5 × 109/L or requiring G-CSF or GM-CSF support o ALT/AST: ITP: ALT/AST: > 3 × ULN AIHA: ALT > 3 ULN. AST up to 5 × ULN may be permitted. o Bilirubin: ITP: total bilirubin > 1.5 × ULN AIHA: direct bilirubin > 1.5 × ULN o International normalized ratio (INR) > 1.5 × ULN

Other protocol-defined inclusion/exclusion criteria may apply.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Kohorte 2
Medicin: Cyclofosfamid
Specificeret dosis på specificerede dage
Biologisk: BMS-986353
Specified dose of specified days
Andre navne:
  • CC-97540
  • Zola-cel
  • Zolacabtagene autoleucel
Medicin: Fludarabine Phosphate
Specified dose of specified days
Eksperimentel: Cohort 1 Part A ITP
Medicin: Cyclofosfamid
Specificeret dosis på specificerede dage
Biologisk: BMS-986353
Specified dose of specified days
Andre navne:
  • CC-97540
  • Zola-cel
  • Zolacabtagene autoleucel
Medicin: Fludarabine Phosphate
Specified dose of specified days
Eksperimentel: Cohort 1 Part A AIHA
Medicin: Cyclofosfamid
Specificeret dosis på specificerede dage
Biologisk: BMS-986353
Specified dose of specified days
Andre navne:
  • CC-97540
  • Zola-cel
  • Zolacabtagene autoleucel
Medicin: Fludarabine Phosphate
Specified dose of specified days
Eksperimentel: Cohort 1 Part B
Medicin: Cyclofosfamid
Specificeret dosis på specificerede dage
Biologisk: BMS-986353
Specified dose of specified days
Andre navne:
  • CC-97540
  • Zola-cel
  • Zolacabtagene autoleucel
Medicin: Fludarabine Phosphate
Specified dose of specified days

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Cohort 1 Part A: Number of participants with treatment-emergent adverse events (TEAEs)
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Cohort 1 Part A: Number of participants with serious AEs (SAEs)
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Cohort 1 Part A: Number of participants with AEs of special interest (AESI)
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Cohort 1 Part A: Number of participants with clinically significant laboratory abnormalities
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Cohort 1 Part B: Hematologic Complete Response (CR)
Tidsramme: Up to approximately Month 6
Up to approximately Month 6

Sekundære resultatmål

Resultatmål
Tidsramme
Cohort 1 PART B: Hematologic Overall Response (OR)
Tidsramme: Up to approximately Month 6
Up to approximately Month 6
Cohort 1 PART A and Cohort 2: Hematologic CR and OR
Tidsramme: Up to approximately Month 6
Up to approximately Month 6
Cohort 1 PART B and Cohort 2: Number of participants with TEAEs
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Cohort 1 PART B and Cohort 2: Number of participants with SAEs
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Cohort 1 PART B and Cohort 2: Number of participants with AESIs
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Cohort 1 PART B and Cohort 2: Number of participants with clinically significant laboratory abnormalities
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Number of participants with Hematologic PR
Tidsramme: Up to approximately Month 6
Up to approximately Month 6
Number of participants with Hematologic CR
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Number of participants with Hematologic PR
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Number of participants with Hematologic OR
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Number of participants with Best Overall Response (BOR)
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Number of participants with durable CR, PR and OR
Tidsramme: Up to approximately 12 months from Zola-cel infusion
Up to approximately 12 months from Zola-cel infusion
Time to First Response (TTR)
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Time to First Complete Response (TTCR)
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Duration of response (DOR)
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Treatment-free Remission (TFR)
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Proportion of participants who requires rescue therapy for ITP or AIHA
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Time to first administration of rescue therapy for ITP or AIHA
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Proportion of AIHA participants who experience hemolysis features
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Number of AIHA participants with cold agglutinin disease (CAD) who experience acrocyanosis
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Change from baseline in hemolysis indicators in AIHA participants
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Proportion of ITP participants with WHO-classified bleeding events as assessed by WHO bleeding scale
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Change from baseline in 36-Item Short Form Health Questionnaire version 2 (SF-36 v2)
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Change from baseline in Patient Global Impression of Severity (PGI-S) Fatigue score
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Patient Global Impression of Change (PGI-C) Fatigue mean score
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Change from baseline in Immune Thrombocytopenia-Patient Assessment Questionnaire (ITP - PAQ) score
Tidsramme: Up to approximately Month 36
Up to approximately Month 36
Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score
Tidsramme: Up to approximately Month 36
Up to approximately Month 36

Samarbejdspartnere og efterforskere

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

Sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Efterforskere

  • Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb

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.

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 (Anslået)

15. juni 2026

Primær færdiggørelse (Anslået)

6. maj 2030

Studieafslutning (Anslået)

6. maj 2030

Datoer for studieregistrering

Først indsendt

18. maj 2026

Først indsendt, der opfyldte QC-kriterier

18. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CA061-1040

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD-delingstidsramme

See Plan Description

IPD-delingsadgangskriterier

See Plan Description

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

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 .

Kliniske forsøg med Autoimmun hæmolytisk anæmi

Kliniske forsøg med Cyclofosfamid

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Sponsorer og samarbejdspartnere

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Narkotikainterventioner

CROs by country

CROs in Morocco

Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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