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NCT05643742PHASE1, PHASE2Recruiting

A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies

CRISPR Therapeutics AG

Start Date

3/10/2023

Completion Date

2/1/2030

Summary

This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX112™ in subjects with relapsed or refractory B-cell malignancies.

Detailed Description

This is an open-label, multi-center Phase 1/2 study of CTX112 in subjects with relapsed/refractory B cell malignancies. CTX112 is an is allogeneic CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).

Eligibility Criteria

Age Range: 18 years to No maximum

Key Inclusion Criteria: 1. Age ≥18 years. 2. Refractory or relapsed B cell malignancy. 3. Eastern Cooperative Oncology Group performance status 0 or 1. 4. Adequate renal, liver, cardiac and pulmonary organ function. 5. Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX112 infusion. Key Exclusion Criteria: 1. Prior allogeneic hematopoietic stem cell transplant (HSCT). 2. Active or history of central nervous system (CNS) involvement by malignancy. 3. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement. 4. Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives. 5. Active HIV, hepatitis B virus or hepatitis C virus infection. 6. Previous or concurrent malignancy in the last 3 years (with the exception of non-melanoma skin cancer and other cancers deemed by the investigator and medical monitor to be of low likelihood for recurrence). 7. Concurrent systemic treatment with an anticancer biologic (e.g., monoclonal antibody) within 30 days prior to CTX112 infusion or with a nonbiological anticancer drug within 14 days prior to CTX112 infusion. 8. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy. 9. Women who are pregnant or breastfeeding.

Interventions

BIOLOGICAL

CTX112

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Conditions

B-cell LymphomaNon-Hodgkin LymphomaB-cell MalignancyChronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)Follicular LymphomaMantle Cell LymphomaMarginal Zone LymphomaLarge B-cell Lymphoma

Locations

University of Kansas

Westwood, Kansas 66205

United States

Washington University

St Louis, Missouri 63110

United States

SCRI

San Antonio, Texas 78229

United States

University of Utah

Salt Lake City, Utah 84112

United States

Royal Prince Alfred

Camperdown, New South Wales 2050

Australia

Alfred Health

Melbourne, Victoria 3004

Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia 6009

Australia