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

  • STATUS
    Recruiting
  • End date
    Jan 28, 2027
  • participants needed
    80
  • sponsor
    CRISPR Therapeutics AG
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Updated on 19 February 2024
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multiple myeloma
refractory multiple myeloma

Summary

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.

Description

The study may enroll approximately 80 subjects in total.

Details
Condition Multiple Myeloma, Multiple Myeloma, Lymphoproliferative Disorder
Age 18years - 100years
Treatment CTX120
Clinical Study IdentifierNCT04244656
SponsorCRISPR Therapeutics AG
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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