RecruitingPhase 1Phase 2NCT05643742

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

A Phase 1/2, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Subjects With Relapsed or Refractory B Cell Malignancies

Sponsor

CRISPR Therapeutics AG

Enrollment

120 participants

Start Date

Mar 10, 2023

Study Type

INTERVENTIONAL

Conditions

Non-Hodgkin Lymphoma Mantle Cell Lymphoma Follicular Lymphoma Marginal Zone Lymphoma B-cell Lymphoma Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)B-cell Malignancy Large B-cell Lymphoma

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Age ≥18 years.
Refractory or relapsed B cell malignancy.
Eastern Cooperative Oncology Group performance status 0 or 1.
Adequate renal, liver, cardiac and pulmonary organ function.
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.

Exclusion Criteria9

Prior allogeneic hematopoietic stem cell transplant (HSCT).
Active or history of central nervous system (CNS) involvement by malignancy.
History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.
Active HIV, hepatitis B virus or hepatitis C virus infection.
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).
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.
Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
Women who are pregnant or breastfeeding.