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.
Title
- Brief Title: A Safety and Efficacy Study Evaluating CTX120 in Subjects With Relapsed or Refractory Multiple Myeloma
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
CRSP-ONC-002
- NCT ID:
NCT04244656
Conditions
Interventions
Drug | Synonyms | Arms |
---|
CTX120 | | CTX120 |
Purpose
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.
Detailed Description
The study may enroll approximately 80 subjects in total.
Trial Arms
Name | Type | Description | Interventions |
---|
CTX120 | Experimental | Administered by IV infusion following lymphodepleting chemotherapy. | |
Eligibility Criteria
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Part A (dose escalation): Incidence of adverse events |
Time Frame: | From CTX120 infusion up to 28 days post-infusion |
Safety Issue: | |
Description: | Adverse events defined as dose-limiting toxicities |
Secondary Outcome Measures
Measure: | Progression Free Survival |
Time Frame: | From date of CTX120 infusion and date of disease progression or death due to any cause, assessed up to 60 months |
Safety Issue: | |
Description: | |
Measure: | Overall Survival |
Time Frame: | From date of CTX120 infusion until date of death due to any cause, assessed up to 60 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | CRISPR Therapeutics AG |
Trial Keywords
- CAR T
- Allogeneic
- Multiple myeloma
- CRISPR-Cas9
Last Updated
July 16, 2021