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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.
Chemotherapy for lymphodepletion
Chemotherapy for lymphodepletion
University of Alabama at Birmingham
Birmingham, Alabama, United States
TERMINATEDBanner MD Anderson Cancer Center
Gilbert, Arizona, United States
RECRUITINGHonorHealth
Scottsdale, Arizona, United States
RECRUITINGUniversity of Arizona Cancer Center
Tucson, Arizona, United States
Primary outcome measures number of patients with dose-limiting toxicities (Part A).
Incidence of adverse events defined as dose-limiting toxicities with onset within 28 days after CB-010 infusion.
Time frame: 28 days following CB-010 infusion
Primary outcome evaluates tumor response (Part B)
The primary endpoint is objective response rate.
Time frame: Up to 12 months
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University of Arkansas
Little Rock, Arkansas, United States
RECRUITINGUniversity of California San Diego Moores Cancer Center
La Jolla, California, United States
RECRUITINGUniversity of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, United States
RECRUITINGChao Family Comprehensive Cancer Center/University of California Irvine
Orange, California, United States
RECRUITINGAdvent Health
Orlando, Florida, United States
RECRUITINGBone and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States
RECRUITING...and 28 more locations