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

8. juli 2026 oppdatert av: 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).

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

52

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiekontakt

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

Studer Kontakt Backup

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

Studiesteder

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

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Kohort 2
Legemiddel: Cyklofosfamid
Spesifisert dose på angitte dager
Biologisk: BMS-986353
Specified dose of specified days
Andre navn:
  • CC-97540
  • Zola-cel
  • Zolacabtagene autoleucel
Legemiddel: Fludarabine Phosphate
Specified dose of specified days
Eksperimentell: Cohort 1 Part A ITP
Legemiddel: Cyklofosfamid
Spesifisert dose på angitte dager
Biologisk: BMS-986353
Specified dose of specified days
Andre navn:
  • CC-97540
  • Zola-cel
  • Zolacabtagene autoleucel
Legemiddel: Fludarabine Phosphate
Specified dose of specified days
Eksperimentell: Cohort 1 Part A AIHA
Legemiddel: Cyklofosfamid
Spesifisert dose på angitte dager
Biologisk: BMS-986353
Specified dose of specified days
Andre navn:
  • CC-97540
  • Zola-cel
  • Zolacabtagene autoleucel
Legemiddel: Fludarabine Phosphate
Specified dose of specified days
Eksperimentell: Cohort 1 Part B
Legemiddel: Cyklofosfamid
Spesifisert dose på angitte dager
Biologisk: BMS-986353
Specified dose of specified days
Andre navn:
  • CC-97540
  • Zola-cel
  • Zolacabtagene autoleucel
Legemiddel: Fludarabine Phosphate
Specified dose of specified days

Hva måler studien?

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

Samarbeidspartnere og etterforskere

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

Sponsor

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

Etterforskere

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

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.

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 (Antatt)

31. august 2026

Primær fullføring (Antatt)

6. mai 2030

Studiet fullført (Antatt)

6. mai 2030

Datoer for studieregistrering

Først innsendt

18. mai 2026

Først innsendt som oppfylte QC-kriteriene

18. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CA061-1040

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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

Tilgangskriterier for IPD-deling

See Plan Description

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

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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