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

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ClinicalTrials.gov Identifier: NCT04637763
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Caribou Biosciences, Inc.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: The CB10A clinical study consists of 3 + 3 design with three dose levels.
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)
Estimated Study Start Date : April 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

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




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.



Information from the National Library of Medicine

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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

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: Cherry Thomas, MD 510-926-9893 ClinicalTrials@CaribouBio.com

Locations
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United States, California
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, Ohio
Oncology Hematology Care Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Eric Clayton    513-751-2273 ext 27135    Eric.Clayton@usoncology.com   
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030-4009
Contact: Ly Dsouza    713-745-8614    ldsouza@mdanderson.org   
Sponsors and Collaborators
Caribou Biosciences, Inc.
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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: April 23, 2021
Last Verified: April 2021
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