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

March 5, 2024 updated by: Caribou Biosciences, Inc.

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
  • Israel
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center
        • Contact:
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center
        • Contact:
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Medical Center
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
    • Arizona
      • Gilbert, Arizona, United States, 85234
      • Scottsdale, Arizona, United States, 85258
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • University of Arizona Cancer Center
        • Contact:
    • California
      • La Jolla, California, United States, 92073
        • Recruiting
        • University of California San Diego Moores Cancer Center
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • Chao Family Comprehensive Cancer Center/University of California Irvine
        • Contact:
    • Florida
      • Orlando, Florida, United States, 32803
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Bone and Marrow Transplant Group of Georgia
        • Contact:
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Georgia Cancer Center at Augusta University
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • Holden Comprehensive Cancer Center at the University of Iowa
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky Markey Cancer
        • Contact:
      • Louisville, Kentucky, United States, 40207
    • New Jersey
    • New York
      • Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center
        • Contact:
      • New York, New York, United States, 10016
    • Ohio
      • Cincinnati, Ohio, United States, 45242
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University James Cancer Hospital
        • Contact:
    • Pennsylvania
    • Texas
      • Dallas, Texas, United States, 75246
      • Houston, Texas, United States, 77030-4009
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute at The University of Utah
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98104
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation of CB-010
Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
Drug: Fludarabine
Chemotherapy for lymphodepletion
Drug: Cyclophosphamide
Chemotherapy for lymphodepletion
Genetic: CB-010
CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.
Experimental: Expansion of CB-010
Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
Drug: Fludarabine
Chemotherapy for lymphodepletion
Drug: Cyclophosphamide
Chemotherapy for lymphodepletion
Genetic: CB-010
CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Caribou Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2021

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 20, 2020

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CB10A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoma

Clinical Trials on Fludarabine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe