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.

Age: 18 Years and older

Gender: All

Start Date: 05/26/2021

Primary Completion Date (Estimated): 08/01/2025

Study Completion Date (Estimated): 09/01/2025

Accepts Healthy Volunteers: No

Trial Purpose and 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.

Eligibility Criteria

Age: 18 Years and older

Gender: All

Accepts 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