Clinical Trials /

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

NCT04244656

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.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

  • Multiple Myeloma

Interventions

DrugSynonymsArms
CTX120CTX120

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

NameTypeDescriptionInterventions
CTX120ExperimentalAdministered by IV infusion following lymphodepleting chemotherapy.
  • CTX120

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

January 27, 2020