Clinical trial NCT04637763: CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
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
Lead sponsor: Caribou Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary outcome measures number of patients with dose-limiting toxicities (Part A).
timeFrame: 28 days following CB-010 infusion
measure: Primary outcome evaluates tumor response (Part B)
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas
state: Arkansas
city: La Jolla
country: United States
facility: University of California San Diego Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: University of Southern California, Norris Comprehensive Cancer Center
state: California
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center/University of California Irvine
state: California
city: Orlando
country: United States
facility: Advent Health
state: Florida
city: Atlanta
country: United States
facility: Bone and Marrow Transplant Group of Georgia
state: Georgia
city: Augusta
country: United States
facility: Georgia Cancer Center at Augusta University
state: Georgia
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center at the University of Iowa
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky Markey Cancer
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Hackensack
country: United States
facility: Hackensack Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Health System
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Nyu Langone Health
state: New York
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Columbus
country: United States
facility: Ohio State University James Cancer Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Charles A. Sammons Cancer Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at the University of Utah
state: Utah
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University (VCU)
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Richmond
country: Australia
facility: Epworth Healthcare
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
city: Tel HaShomer
country: Israel
facility: The Sheba Fund for Health Services and Research (R.A.)
Study officials:
References: