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CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)

PHASE1RECRUITING

CB010A is a study evaluating safety, emerging efficacy, pharmacokinetics and immunogenicity of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma after lymphodepletion consisting of cyclophosphamide and fludarabine.

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Study details:

This clinical trial is a first-in-human, Phase 1, multicenter, open-label evaluation of safety and emerging efficacy of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma. The study is conducted in two parts: Part A is dose escalation following a 3 + 3 design, with sequential, prespecified, increasing doses. Part B is the expansion portion where patients will receive CB-010 at the dose determined in Part A.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • Age greater than or equal to 18 at the time of enrollment
  • Documented diagnosis of relapsed or refractory non-Hodgkin lymphoma after prior standard of care
  • Eastern Cooperative Oncology Group performance status 0 or 1
  • Adequate hematologic, renal, liver, cardiac and pulmonary organ function
  • Exclusion criteria

  • Prior therapy with an anti-CD19 targeting agent
  • Active or chronic graft versus host disease requiring therapy
  • Prior allogeneic stem cell transplantation
  • Central nervous system (CNS) lymphoma, prior CNS malignancy
  • Prior seizure disorder, cerebrovascular ischemia, dementia, cerebellar disease or autoimmune disease with CNS involvement.
  • Primary immunodeficiency
  • Current or expected need for systemic corticosteroid therapy
  • Current thyroid disorder. Hypothyroidism controlled with stable hormone replacement is permitted
  • Other malignancy within 2 years of study entry, except curatively treated malignancies or malignancies with low risk of recurrence
  • Unwillingness to follow extended safety monitoring
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2021-05-26

    Primary completion: 2025-08-01

    Study completion finish: 2025-09-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

    trial

    Trial ID

    NCT04637763

    Intervention or treatment

    GENETIC: CB-010

    DRUG: Cyclophosphamide

    DRUG: Fludarabine

    Conditions

    • Lymphoma, Non-Hodgkin
    • Non Hodgkin Lymphoma
    • Lymphoma
    • Relapsed Non Hodgkin Lymphoma
    • Refractory B-Cell Non-Hodgkin Lymphoma
    • B Cell Lymphoma
    • B Cell Non-Hodgkin's Lymphoma
    Image related to Lymphoma, Non-Hodgkin
    • Condition: Lymphoma, Non-Hodgkin, Non Hodgkin Lymphoma and more

    • GENETIC: CB-010 and other drugs

    • Westmead, New South Wales, Australia and more

    • Sponsor: Caribou Biosciences, Inc.

    Find a site

    Closest Location:

    Westmead Hospital

    Research sites nearby

    Select from list below to view details:

    • Westmead Hospital

      Westmead, New South Wales, Australia

    • Epworth Healthcare

      Richmond, Victoria, Australia

    • Royal Perth Hospital

      Perth, Western Australia, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: Dose Escalation of CB-010
    • Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
    GENETIC: CB-010
    • CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.
    EXPERIMENTAL: Expansion of CB-010
    • Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
    GENETIC: CB-010
    • CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Primary outcome measures number of patients with dose-limiting toxicities (Part A).Incidence of adverse events defined as dose-limiting toxicities with onset within 28 days after CB-010 infusion.28 days following CB-010 infusion
    Primary outcome evaluates tumor response (Part B)The primary endpoint is objective response rate.Up to 12 months

    Secondary outcome

    Frequently Asked Questions

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    References

    Clinical Trials Gov: CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)

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