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

March 21, 2025 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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:
      • Tel HaShomer, Israel, 5265601
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Terminated
        • University of Alabama at Birmingham
    • Arizona
      • Gilbert, Arizona, United States, 85234
      • Scottsdale, Arizona, United States, 85258
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • University of Arizona Cancer Center
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas
        • Contact:
    • California
      • La Jolla, California, United States, 92073
        • Recruiting
        • University Of California San Diego Moores Cancer Center
        • Contact:
      • Los Angeles, California, United States, 90089
        • Recruiting
        • University of Southern California, Norris Comprehensive 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
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
    • 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
        • Terminated
        • Ohio State University James Cancer Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
    • Pennsylvania
    • Tennessee
      • Nashville, Tennessee, United States, 37323
    • 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:
    • Virginia
      • Norfolk, Virginia, United States, 23502
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Virginia Commonwealth University (VCU)
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98104
        • Terminated
        • Swedish Cancer Institute
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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