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

Primary Purpose

Lymphoma, Non-Hodgkin, Relapsed Non Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CB-010
Cyclophosphamide
Fludarabine
Sponsored by
Caribou Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • HonorHealthRecruiting
  • University of Arizona Cancer CenterRecruiting
  • University of California San Diego Moores Cancer CenterRecruiting
  • Chao Family Comprehensive Cancer Center/University of California IrvineRecruiting
  • Advent HealthRecruiting
  • Bone and Marrow Transplant Group of GeorgiaRecruiting
  • Georgia Cancer Center at Augusta UniversityRecruiting
  • Holden Comprehensive Cancer Center at the University of IowaRecruiting
  • University of Kentucky Markey CancerRecruiting
  • Norton Cancer InstituteRecruiting
  • Atlantic Health SystemRecruiting
  • Montefiore Medical CenterRecruiting
  • Oncology Hematology CareRecruiting
  • Ohio State University James Cancer HospitalRecruiting
  • Baylor Charles A. Sammons Cancer CenterRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Huntsman Cancer Institute at the University of UtahRecruiting
  • Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dose Escalation of CB-010

Expansion of CB-010

Arm Description

Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.

Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.

Outcomes

Primary Outcome Measures

Primary outcome measures number of patients with dose-limiting toxicities (Part A).
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)
The primary endpoint is objective response rate.

Secondary Outcome Measures

Full Information

First Posted
November 16, 2020
Last Updated
October 23, 2023
Sponsor
Caribou Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04637763
Brief Title
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Caribou Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation of CB-010
Arm Type
Experimental
Arm Description
Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
Arm Title
Expansion of CB-010
Arm Type
Experimental
Arm Description
Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
Intervention Type
Genetic
Intervention Name(s)
CB-010
Intervention Description
CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Chemotherapy for lymphodepletion
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Chemotherapy for lymphodepletion
Primary Outcome Measure Information:
Title
Primary outcome measures number of patients with dose-limiting toxicities (Part A).
Description
Incidence of adverse events defined as dose-limiting toxicities with onset within 28 days after CB-010 infusion.
Time Frame
28 days following CB-010 infusion
Title
Primary outcome evaluates tumor response (Part B)
Description
The primary endpoint is objective response rate.
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Socorro Portella, MD
Phone
973 866 7567
Email
clinicaltrials@cariboubio.com
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amitkumar Mehta
Phone
205-996-8400
Email
amitkumarmehta@uabmc.edu
Facility Name
HonorHealth
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Nurse Navigator
Phone
480-323-1364
Email
clinicaltrials@honorhealth.com
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francois Chu
Phone
520-621-0823
Email
fchu@arizona.edu
Facility Name
University of California San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Padilla
Phone
858-822-5223
Email
mlp002@health.ucsd.edu
Facility Name
Chao Family Comprehensive Cancer Center/University of California Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blake Johnson
Phone
714-456-3476
Email
blakej@hs.uci.edu
Facility Name
Advent Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen Wing
Phone
407-303-8251
Email
Kristen.Wing@adventhealth.org
Facility Name
Bone and Marrow Transplant Group of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melhem Solh, MD
Phone
404-255-1930
Email
msolh@bmtga.com
Facility Name
Georgia Cancer Center at Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Jenkins
Phone
706-721-1206
Email
kejenkins@augusta.edu
Facility Name
Holden Comprehensive Cancer Center at the University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Umar Farooq
Phone
319-384-8044
Email
umar-farooq@uiowa.edu
Facility Name
University of Kentucky Markey Cancer
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvonne Taul
Phone
859-323-7628
Email
Yvonne.Taul@uky.edu
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tabby Thomas
Phone
502-899-3366
Email
StudyStartup@NCIResearch.org
Facility Name
Atlantic Health System
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Hall
Phone
973-971-5235
Email
Amandamaria.hall@atlantichealth.org
First Name & Middle Initial & Last Name & Degree
Salome Greene
Phone
973-971-6373
Email
salome.geene@atlantichealth.org
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joel Victor
Phone
718-430-8761
Email
jovictor@montefiore.org
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Clayton
Phone
513-751-2273
Ext
27135
Email
Eric.Clayton@usoncology.com
Facility Name
Ohio State University James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Needham
Phone
614-293-7934
Email
Thomas.Needham@osumc.edu
Facility Name
Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tarah Satterfield
Phone
214-818-8472
Email
Tarah.Satterfield@BSWHealth.org
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ly Dsouza
Phone
713-745-8614
Email
ldsouza@mdanderson.org
Facility Name
Huntsman Cancer Institute at the University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erin Peterson
Phone
801-587-4655
Email
erin.peterson@hci.utah.edu
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roisin McAndrew
Phone
414-805-5447
Email
rmcandrew@mcw.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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