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Active, not recruiting Phase 1

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

NCT04637763 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2021-05-26
Last updated
2026-10-19

Condition(s) studied

Lymphoma, Non-HodgkinRelapsed Non Hodgkin LymphomaRefractory B-Cell Non-Hodgkin LymphomaNon Hodgkin LymphomaLymphomaB Cell LymphomaB Cell Non-Hodgkin's Lymphoma

Investigational drug(s) / intervention(s)

CB-010Cyclophosphamide →Fludarabine →

CB-010: CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.

Cyclophosphamide: Chemotherapy for lymphodepletion

Fludarabine: Chemotherapy for lymphodepletion

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • Primary outcome measures number of patients with dose-limiting toxicities (Part A). — 28 days following CB-010 infusion
    Incidence of adverse events defined as dose-limiting toxicities with onset within 28 days after CB-010 infusion.
  • Primary outcome evaluates tumor response (Part B) — Up to 12 months
    The primary endpoint is objective response rate.

Trial sites (38)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
Banner MD Anderson Cancer Center Gilbert Arizona
HonorHealth Scottsdale Arizona
University of Arizona Cancer Center Tucson Arizona
University of Arkansas Little Rock Arkansas
University of California San Diego Moores Cancer Center La Jolla California
University of Southern California, Norris Comprehensive Cancer Center Los Angeles California
Chao Family Comprehensive Cancer Center/University of California Irvine Orange California
Advent Health Orlando Florida
Bone and Marrow Transplant Group of Georgia Atlanta Georgia
Augusta University/Georgia Cancer Center Augusta Georgia
University of Iowa Hospitals & Clinics Iowa City Iowa
University of Kentucky Lexington Kentucky
Norton Cancer Institute Louisville Kentucky
Tufts Medical Center Boston Massachusetts
Regional Cancer Care Associates LLC - Hackensack Hackensack New Jersey
Atlantic Health System Morristown New Jersey
NYU Langone Health New York New York
Montefiore Medical Center New York New York
Oncology Hematology Care Cincinnati Ohio
Ohio State University Medical Group Columbus Ohio
Oregon Health & Science University (OHSU) Portland Oregon
University of Pennsylvania Philadelphia Pennsylvania
Vanderbilt University Medical Center Nashville Tennessee
Baylor Charles A. Sammons Cancer Center Dallas Texas
MD Anderson Cancer Center Houston Texas
Huntsman Cancer Institute at the University of Utah Salt Lake City Utah
Virginia Oncology Associates Norfolk Virginia
Virginia Commonwealth University (VCU) Richmond Virginia
Swedish Cancer Institute Seattle Washington
Medical College of Wisconsin Milwaukee Wisconsin
Westmead Hospital Westmead New South Wales
Epworth Healthcare Richmond Victoria
Royal Perth Hospital Perth Western Australia
The Tel Aviv Sourasky Medical Center Tel Aviv Tel Aviv-Yafo
Hadassah Medical Center Jerusalem Israel
Rabin Medical Center - Beilinson Hospital Petah Tikva Israel
The Sheba Fund for Health Services and Research (R.A.) Tel Litwinsky Israel
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04637763 on ClinicalTrials.gov ↗ ← All trials in the USA