CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)
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.
Lymphoma,
Phase I
Phase I
Adults
Chemotherapy - cytotoxic,
Mol. targeted/Immunotherapy/Biologics
Not Available
Oluwole, Olalekan
International
Vanderbilt University
05-08-2024
Eligibility
18 Years and older
ALL
false
Inclusion Criteria:
Age greater than or equal to 18 at the time of enrollment
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
Documented diagnosis of relapsed or refractory non-Hodgkin lymphoma after prior standard of care
Eastern Cooperative Oncology Group performance status 0 or 1
Eastern Cooperative Oncology Group performance status 0 or 1
Adequate hematologic, renal, liver, cardiac and pulmonary organ function
Adequate hematologic, renal, liver, cardiac and pulmonary organ function
Exclusion Criteria:
Prior therapy with an anti-CD19 targeting agent
Prior therapy with an anti-CD19 targeting agent
Active or chronic graft versus host disease requiring therapy
Active or chronic graft versus host disease requiring therapy
Prior allogeneic stem cell transplantation
Prior allogeneic stem cell transplantation
Central nervous system (CNS) lymphoma, prior CNS malignancy
Central nervous system (CNS) lymphoma, prior CNS malignancy
Prior seizure disorder, cerebrovascular ischemia, dementia, cerebellar disease or autoimmune disease with CNS involvement.
Prior seizure disorder, cerebrovascular ischemia, dementia, cerebellar disease or autoimmune disease with CNS involvement.
Primary immunodeficiency
Primary immunodeficiency
Current or expected need for systemic corticosteroid therapy
Current or expected need for systemic corticosteroid therapy
Current thyroid disorder. Hypothyroidism controlled with stable hormone replacement is permitted
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
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
Unwillingness to follow extended safety monitoring
Age greater than or equal to 18 at the time of enrollment
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
Documented diagnosis of relapsed or refractory non-Hodgkin lymphoma after prior standard of care
Eastern Cooperative Oncology Group performance status 0 or 1
Eastern Cooperative Oncology Group performance status 0 or 1
Adequate hematologic, renal, liver, cardiac and pulmonary organ function
Adequate hematologic, renal, liver, cardiac and pulmonary organ function
Exclusion Criteria:
Prior therapy with an anti-CD19 targeting agent
Prior therapy with an anti-CD19 targeting agent
Active or chronic graft versus host disease requiring therapy
Active or chronic graft versus host disease requiring therapy
Prior allogeneic stem cell transplantation
Prior allogeneic stem cell transplantation
Central nervous system (CNS) lymphoma, prior CNS malignancy
Central nervous system (CNS) lymphoma, prior CNS malignancy
Prior seizure disorder, cerebrovascular ischemia, dementia, cerebellar disease or autoimmune disease with CNS involvement.
Prior seizure disorder, cerebrovascular ischemia, dementia, cerebellar disease or autoimmune disease with CNS involvement.
Primary immunodeficiency
Primary immunodeficiency
Current or expected need for systemic corticosteroid therapy
Current or expected need for systemic corticosteroid therapy
Current thyroid disorder. Hypothyroidism controlled with stable hormone replacement is permitted
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
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
Unwillingness to follow extended safety monitoring
