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A Safety and Efficacy Study Evaluating CTX120 in Subjects With Relapsed or Refractory Multiple Myeloma

Trial Status: Active

This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX120 in subjects with relapsed or refractory multiple myeloma.

Inclusion Criteria

  • Age ≥18 years.
  • Relapsed or refractory multiple myeloma, as defined by IMWG response criteria and treatment with at least 2 prior lines of 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 CTX120 infusion.

Exclusion Criteria

  • Prior allogeneic stem cell transplant (SCT).
  • Less than 60 days from autologous SCT at time of screening and with unresolved serious complications.
  • Prior treatment with any gene therapy or genetically modified cell therapy, including CAR T cells or natural killer cells, or BCMA-directed therapy.
  • Evidence of direct central nervous system (CNS) involvement by multiple myeloma.
  • History or presence of clinically relevant CNS pathology such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disease with CNS involvement.
  • Unstable angina, clinically significant arrhythmia, or myocardial infarction within 6 months of enrollment.
  • 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 prior to enrollment.
  • Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
  • Women who are pregnant or breastfeeding.

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

The study may enroll approximately 80 subjects in total.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
CRISPR Therapeutics AG

  • Primary ID CRSP-ONC-002
  • Secondary IDs NCI-2020-04365
  • Clinicaltrials.gov ID NCT04244656