A Safety and Efficacy Study Evaluating CTX120 in Subjects With Relapsed or Refractory Multiple Myeloma
Megadott ok: Patients to be followed up in the CRSP-ONC-LTF study
Key facts
- Where
- Chicago, Nashville, Philadelphia és Portland, Egyesült ÁllamokSee the 4 sites
- Phase
- 1. fázis
Where in Egyesült Államok
- University of ChicagoChicago, Egyesült ÁllamokNo longer taking part
- Sarah Cannon Research InstituteNashville, Egyesült ÁllamokNo longer taking part
- University of PennsylvaniaPhiladelphia, Egyesült ÁllamokNo longer taking part
- Oregon Health and Science UniversityPortland, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- CRISPR Therapeutics AG
- Trial code
- NCT04244656
- Record updated
- 2025. január 8.
- Original description
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.Read full original descriptionShow less
A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-BCMA Allogeneic CRISPR-Cas9-Engineered T Cells (CTX120) in Subjects With Relapsed or Refractory Multiple Myeloma
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: 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: Prior allogeneic stem cell transplant (SCT); Prior treatment with any gene therapy or genetically modified cell therapy, including CAR T cells or natural killer cells, or BCMA-directed therapy; Use of systemic anti-tumor therapy or investigational agent within 14 days prior to enrollment; 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; Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy; 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; Less than 60 days from autologous SCT at time of screening and with unresolved serious complications; Evidence of direct central nervous system (CNS) involvement by multiple myeloma; Women who are pregnant or breastfeeding.