Description:
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.
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.
Recruiting
Phase 1
Drug | Synonyms | Arms |
---|---|---|
Cyclophosphamide | Dose Escalation of CB-010 | |
Fludarabine | Dose Escalation of CB-010 |
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.
Name | Type | Description | Interventions |
---|---|---|---|
Dose Escalation of CB-010 | Experimental | Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion. |
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Expansion of CB-010 | Experimental | Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion. |
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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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Primary outcome measures number of patients with dose-limiting toxicities (Part A). |
Time Frame: | 28 days following CB-010 infusion |
Safety Issue: | |
Description: | Incidence of adverse events defined as dose-limiting toxicities with onset within 28 days after CB-010 infusion. |
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Caribou Biosciences, Inc. |
August 23, 2021