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

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.

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
The CB10A clinical study consists of (Part A) 3 + 3 design with three dose levels. (Part B) Expansion portion patients will receive CB-010 at the dose determined in Part A.
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Cyclophosphamide
    Chemotherapy for lymphodepletion
  • Drug: Fludarabine
    Chemotherapy for lymphodepletion
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.
  • Drug: Cyclophosphamide
    Chemotherapy for lymphodepletion
  • Drug: Fludarabine
    Chemotherapy for lymphodepletion

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Amitkumar Mehta
205-996-8400
amitkumarmehta@uabmc.edu

More Details

Status
Recruiting
Sponsor
Caribou Biosciences, Inc.

Study Contact

Socorro Portella, MD
973 866 7567
clinicaltrials@cariboubio.com

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.