CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)

Caribou Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Refractory B-Cell Non-Hodgkin Lymphoma; B Cell Lymphoma; Lymphoma; Non Hodgkin Lymphoma; Relapsed Non Hodgkin Lymphoma; Lymphoma, Non-Hodgkin; B Cell Non-Hodgkin's Lymphoma

Treatments: Genetic: CB-010; Drug: Cyclophosphamide; Drug: Fludarabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04637763

CB10A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Dose Escalation of CB-010

Experimental group

Description:

Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.

Treatment:

Drug: Fludarabine

Drug: Cyclophosphamide

Genetic: CB-010

Expansion of CB-010

Experimental group

Description:

Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.

Treatment:

Drug: Fludarabine

Drug: Cyclophosphamide

Genetic: CB-010