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

C

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

Drug: Cyclophosphamide
Genetic: CB-010
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)

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
Genetic: CB-010
Drug: Cyclophosphamide
Expansion of CB-010
Experimental group
Description:
Patients with relapsed or refractory non-Hodgkin lymphoma will receive CB-010 following lymphodepletion.
Treatment:
Drug: Fludarabine
Genetic: CB-010
Drug: Cyclophosphamide

Trial contacts and locations

30

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Central trial contact

Socorro Portella, MD

Data sourced from clinicaltrials.gov

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