Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

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.

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)

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.

Keywords

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 Lymphoma, B-Cell Cyclophosphamide Fludarabine Dose Escalation of CB-010 Expansion of CB-010

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Chao Family Comprehensive Cancer Center/University of California Irvine accepting new patients
    Orange California 92868 United States
  • University of California San Diego Moores Cancer Center accepting new patients
    La Jolla California 92073 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Caribou Biosciences, Inc.
ID
NCT04637763
Phase
Phase 1
Study Type
Interventional
Last Updated