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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04637763
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : March 22, 2023
Sponsor:
Information provided by (Responsible Party):
Caribou Biosciences, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Genetic: CB-010 Drug: Cyclophosphamide Drug: Fludarabine Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 26, 2021
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation of CB-010
Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
 Genetic: CB-010
CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.

Drug: Cyclophosphamide
Chemotherapy for lymphodepletion

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

Drug: Cyclophosphamide
Chemotherapy for lymphodepletion

Drug: Fludarabine
Chemotherapy for lymphodepletion


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Primary outcome evaluates tumor response (Part B) [ Time Frame: Up to 12 months ]
    The primary endpoint is objective response rate.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04637763


Contacts
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Contact: Socorro Portella, MD 973 866 7567 SPortella@CaribouBio.com

Locations
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United States, Arizona
HonorHealth Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Research Nurse Navigator    480-323-1364    clinicaltrials@honorhealth.com   
United States, California
University of California San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92073
Contact: Michelle Padilla    858-822-5223    mlp002@health.ucsd.edu   
Chao Family Comprehensive Cancer Center/University of California Irvine Recruiting
Orange, California, United States, 92868
Contact: Blake Johnson    714-456-3476    blakej@hs.uci.edu   
United States, Iowa
Holden Comprehensive Cancer Center at the University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Umar Farooq    319-384-8044    umar-farooq@uiowa.edu   
United States, New Jersey
Atlantic Health System Recruiting
Morristown, New Jersey, United States, 07960
Contact: Amanda Hall    973-971-5235    Amandamaria.hall@atlantichealth.org   
Contact: Salome Greene    973-971-6373    salome.geene@atlantichealth.org   
United States, Ohio
Oncology Hematology Care Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Eric Clayton    513-751-2273 ext 27135    Eric.Clayton@usoncology.com   
Ohio State University James Cancer Hospital Recruiting
Columbus, Ohio, United States, 43210
Contact: Thomas Needham    614-293-7934    Thomas.Needham@osumc.edu   
United States, Texas
Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Tarah Satterfield    214-818-8472    Tarah.Satterfield@BSWHealth.org   
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030-4009
Contact: Ly Dsouza    713-745-8614    ldsouza@mdanderson.org   
United States, Utah
Huntsman Cancer Institute at the University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Erin Peterson    801-587-4655    erin.peterson@hci.utah.edu   
Sponsors and Collaborators
Caribou Biosciences, Inc.
More Information
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Responsible Party: Caribou Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT04637763    
Other Study ID Numbers: CB10A
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: March 22, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
 Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists