A Safety and Efficacy Study Evaluating CTX120 in Subjects With Relapsed or Refractory Multiple Myeloma
A Safety and Efficacy Study Evaluating 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.
The study may enroll approximately 80 subjects in total.
Key Inclusion Criteria:

 1. Age ≥18 years.

 2. Relapsed or refractory multiple myeloma, as defined by IMWG response criteria and
 treatment with at least 2 prior lines of therapy.

 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
 CTX120 infusion.

 Key Exclusion Criteria:

 1. Prior allogeneic stem cell transplant (SCT).

 2. Less than 60 days from autologous SCT at time of screening and with unresolved serious
 complications.

 3. Prior treatment with any gene therapy or genetically modified cell therapy, including
 CAR T cells or natural killer cells, or BCMA-directed therapy.

 4. Evidence of direct central nervous system (CNS) involvement by multiple myeloma.

 5. 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.

 6. Unstable angina, clinically significant arrhythmia, or myocardial infarction within 6
 months of enrollment.

 7. Active HIV, hepatitis B virus or hepatitis C virus infection.

 8. 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.

 9. Use of systemic anti-tumor therapy or investigational agent within 14 days prior to
 enrollment.

 10. Primary immunodeficiency disorder or active autoimmune disease requiring steroids
 and/or other immunosuppressive therapy.

 11. Women who are pregnant or breastfeeding.