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A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies

PHASE1PHASE2RECRUITING

This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX112™ in subjects with relapsed or refractory B-cell malignancies.

Study details:

This is an open-label, multi-center Phase 1/2 study of CTX112 in subjects with relapsed/refractory B cell malignancies. CTX112 is an is allogeneic CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).

Eligibility criteria

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

Inclusion criteria

  1. Age ≥18 years.
  2. Refractory or relapsed B cell malignancy.
  3. Eastern Cooperative Oncology Group performance status 0 or 1.
  4. Adequate renal, liver, cardiac and pulmonary organ function.
  5. Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX112 infusion.

Exclusion criteria

  1. Prior allogeneic hematopoietic stem cell transplant (HSCT).
  2. Active or history of central nervous system (CNS) involvement by malignancy.
  3. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
  4. Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.
  5. Active HIV, hepatitis B virus or hepatitis C virus infection.
  6. Previous or concurrent malignancy in the last 3 years (with the exception of non-melanoma skin cancer and other cancers deemed by the investigator and medical monitor to be of low likelihood for recurrence).
  7. Concurrent systemic treatment with an anticancer biologic (e.g., monoclonal antibody) within 30 days prior to CTX112 infusion or with a nonbiological anticancer drug within 14 days prior to CTX112 infusion.
  8. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
  9. Women who are pregnant or breastfeeding.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1PHASE2

trial

Study ID

NCT05643742

Intervention or treatment

BIOLOGICAL: CTX112

Conditions

  • B-cell Lymphoma
  • Non-Hodgkin Lymphoma
  • B-cell Malignancy
  • Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
  • Follicular Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Large B-cell Lymphoma

  • Condition: B-cell Lymphoma, Non-Hodgkin Lymphoma and more

  • BIOLOGICAL: CTX112

  • Camperdown, New South Wales, Australia and more

  • Sponsor: CRISPR Therapeutics AG

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Research Site

Select from list below to view details:

  • Research Site

    Camperdown, New South Wales, Australia

  • Research Site

    Melbourne, Victoria, Australia

  • Research Site

    Nedlands, Western Australia, Australia

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Who is running the clinical trial?

CTA

CRISPR Therapeutics AG

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: CTX112
  • Administered by IV infusion following lymphodepleting chemotherapy.
Biological: CTX112

    What is the study measuring?

    Primary Outcome

    MeasureDescriptionTime Frame
    Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicitiesNot SpecifiedFrom CTX112 infusion up to 28 days post-infusion
    Phase 2 (Cohort Expansion): Objective response rateNot SpecifiedFrom CTX112 infusion up to 60 months post-infusion

    Secondary Outcome

    MeasureDescriptionTime Frame
    Duration of ResponseDuration of Response (DOR) will only be reported for subjects who have had CR/PR eventsFrom date of first objective response of complete response (CR)/partial response (PR) until date of disease progression or death due to any cause, assessed up to 60 months
    Duration of Clinical Benefit (DOCB)Not SpecifiedFrom date of first objective response of CR/PR until the relapse or death that followed the last response, assessed up to 60 months
    Progression Free SurvivalNot SpecifiedFrom date of CTX112 infusion until date of disease progression or death due to any cause, assessed up to 60 months
    Overall SurvivalNot SpecifiedFrom date of CTX112 infusion until date of death due to any cause, assessed up to 60 months
    Are you running this trial?If you're a clinic or sponsor, you can claim this study.
    Claim this trial

    References

    Clinical Trials Gov: A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies

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