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.
Brief Title
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
973 866 7567
Central Contact Email
clinicaltrials@cariboubio.com
Completion Date
Completion Date Type
Estimated
Conditions
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
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04637763
Org Class
Industry
Org Full Name
Caribou Biosciences, Inc.
Org Study Id
CB10A
Overall Status
Recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
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)
Primary Outcomes
Outcome Description
Incidence of adverse events defined as dose-limiting toxicities with onset within 28 days after CB-010 infusion.
Outcome Measure
Primary outcome measures number of patients with dose-limiting toxicities (Part A).
Outcome Time Frame
28 days following CB-010 infusion
Outcome Description
The primary endpoint is objective response rate.
Outcome Measure
Primary outcome evaluates tumor response (Part B)
Outcome Time Frame
Up to 12 months
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Noah Kornblum
Investigator Email
nkornblu@montefiore.org
Investigator Phone
718-920-4826