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A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies

Trial Status: Active

This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies.

Inclusion Criteria

  • Age ≥18 years.
  • Refractory or relapsed non-Hodgkin lymphoma, as evidenced by 2 or more lines of prior therapy.
  • 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 CTX110 infusion.
  • Agree to participate in an additional long-term follow-up study after completion of this study.

Exclusion Criteria

  • Treatment with any gene therapy or genetically modified cell therapy, including CAR T cells.
  • Prior allogeneic HSCT.
  • 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, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥5 years.
  • Use of systemic anti-tumor therapy or investigational agent within 14 days or 5 half-lives, whichever is longer, of enrollment.
  • Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
  • Women who are pregnant or breastfeeding.

California

Duarte
City of Hope Comprehensive Cancer Center
Status: IN_REVIEW

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Dana Wheeler
Phone: 913-945-7550

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

The study may enroll up to 95 subjects in total.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
CRISPR Therapeutics AG

  • Primary ID CRSP-ONC-001
  • Secondary IDs NCI-2019-07066
  • Clinicaltrials.gov ID NCT04035434