Non Hodgkin Lymphoma Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT04637763

Recruitment Status:

Recruiting

Sponsor:

Caribou Biosciences, Inc.

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There are 9 Locations for this study

See Locations Near You

HonorHealth
Scottsdale Arizona, 85258, United States More Info
Research Nurse Navigator
Contact
480-323-1364
[email protected]
University of California San Diego Moores Cancer Center
La Jolla California, 92073, United States More Info
Michelle Padilla
Contact
858-822-5223
[email protected]
Chao Family Comprehensive Cancer Center/University of California Irvine
Orange California, 92868, United States More Info
Blake Johnson
Contact
714-456-3476
[email protected]
Atlantic Health System
Morristown New Jersey, 07960, United States More Info
Amanda Hall
Contact
973-971-5235
[email protected]
Salome Greene
Contact
973-971-6373
[email protected]
Oncology Hematology Care
Cincinnati Ohio, 45242, United States More Info
Eric Clayton
Contact
513-751-2273
[email protected]
Ohio State University James Cancer Hospital
Columbus Ohio, 43210, United States More Info
Thomas Needham
Contact
614-293-7934
[email protected]
Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States More Info
Tarah Satterfield
Contact
214-818-8472
[email protected]
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Ly Dsouza
Contact
713-745-8614
[email protected]
Huntsman Cancer Institute at the University of Utah
Salt Lake City Utah, 84112, United States More Info
Erin Peterson
Contact
801-587-4655
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT04637763

Recruitment Status:

Recruiting

Sponsor:


Caribou Biosciences, Inc.

How clear is this clinincal trial information?

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