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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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.