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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2025
  • participants needed
    50
  • sponsor
    Caribou Biosciences, Inc.
Updated on 1 May 2021

Summary

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.

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.

Details
Condition Lymphoma, Lymphoproliferative Disorder, Lymphoma, B-Cell Lymphoma, Non-Hodgkin's Lymphoma, Lymphoma, B-Cell, Relapsed Non Hodgkin Lymphoma, Lymphoproliferative disorders, non-hodgkin's lymphoma (nhl), lymphomas, b-cell lymphomas, b cell lymphomas, b cell lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma
Treatment cyclophosphamide, Fludarabine, CB-010
Clinical Study IdentifierNCT04637763
SponsorCaribou Biosciences, Inc.
Last Modified on1 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Lymphoma or Lymphoma, B-Cell or Lymphoproliferative Disorder or b-cell lymphomas or B-Cell Lymphoma or b cell lymphomas or Lymphoproliferative disorde...?
Do you have any of these conditions: Lymphoma, B-Cell or b cell lymphomas or non-hodgkin's lymphoma (nhl) or Non-Hodgkin's Lymphoma or Relapsed Non Hodgkin Lymphoma or Refractory B-Cell N...?
Do you have any of these conditions: lymphomas or B-Cell Lymphoma or Relapsed Non Hodgkin Lymphoma or Lymphoproliferative disorders or b cell lymphomas or b cell lymphoma or Non-Hodgkin's...?
Do you have any of these conditions: lymphomas or Lymphoproliferative Disorder or Lymphoma or Lymphoma, B-Cell or b cell lymphomas or non-hodgkin's lymphoma (nhl) or b-cell lymphomas or L...?
Do you have any of these conditions: Lymphoma or Lymphoma, B-Cell or Non-Hodgkin's Lymphoma or Lymphoproliferative disorders or Lymphoproliferative Disorder or B-Cell Lymphoma or b cell l...?
Do you have any of these conditions: b cell lymphoma or Lymphoproliferative disorders or Lymphoma or lymphomas or B-Cell Lymphoma or Non-Hodgkin's Lymphoma or b-cell lymphomas or Lymphoma...?
Do you have any of these conditions: b cell lymphoma or B-Cell Lymphoma or non-hodgkin's lymphoma (nhl) or Refractory B-Cell Non-Hodgkin Lymphoma or Lymphoproliferative Disorder or Non-Ho...?
Do you have any of these conditions: B-Cell Lymphoma or b cell lymphoma or Non-Hodgkin's Lymphoma or b-cell lymphomas or lymphomas or Lymphoproliferative disorders or b cell lymphomas or ...?
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
Clear my responses

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