B Cell Lymphoma, B Cell Non-Hodgkin's Lymphoma, Lymphoma, Lymphoma, Non-Hodgkin, Non Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Relapsed Non Hodgkin Lymphoma
Conditions
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.
Interventions
GENETICCB-010
CB-010 is a CRISPR-edited allogeneic CAR-T cell therapy targeting CD19.
DRUGCyclophosphamide
Chemotherapy for lymphodepletion
DRUGFludarabine
Chemotherapy for lymphodepletion
Sponsors
Caribou Biosciences, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome measures number of patients with dose-limiting toxicities (Part A). | 28 days following CB-010 infusion | 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) | Up to 12 months | The primary endpoint is objective response rate. |
Countries
Australia, Israel, United States
Contacts
Primary ContactSocorro Portella, MD
Outcome results
None listed