Clinical Trials /

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

NCT04637763

Description:

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.

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma
  • Official Title: A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients With Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)

Clinical Trial IDs

  • ORG STUDY ID: CB10A
  • NCT ID: NCT04637763

Conditions

  • Lymphoma, Non-Hodgkin
  • Relapsed Non Hodgkin Lymphoma
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Non Hodgkin Lymphoma
  • Lymphoma
  • B Cell Lymphoma
  • B Cell Non-Hodgkin's Lymphoma

Interventions

DrugSynonymsArms
CyclophosphamideDose Escalation of CB-010
FludarabineDose Escalation of CB-010

Purpose

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.

Detailed Description

      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.
    

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation of CB-010ExperimentalPatients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
  • Cyclophosphamide
  • Fludarabine
Expansion of CB-010ExperimentalPatients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
  • Cyclophosphamide
  • Fludarabine

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Primary outcome measures number of patients with dose-limiting toxicities (Part A).
Time Frame:28 days following CB-010 infusion
Safety Issue:
Description:Incidence of adverse events defined as dose-limiting toxicities with onset within 28 days after CB-010 infusion.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Caribou Biosciences, Inc.

Last Updated

March 29, 2021