Multiple Myeloma Clinical Trial

A Safety and Efficacy Study Evaluating CTX120 in Subjects With Relapsed or 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.

View Eligibility Criteria

Eligibility Criteria

Key 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.

Key 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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

26

Study ID:

NCT04244656

Recruitment Status:

Active, not recruiting

Sponsor:

CRISPR Therapeutics AG

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There are 10 Locations for this study

See Locations Near You

University of Chicago
Chicago Illinois, 60637, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Royal Prince Alfred Hospital
Sydney New South Wales, 2050, Australia
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia
University Health Network, Princess Margaret Cancer Centre
Toronto Ontario, M5G 1, Canada
Institut Catala d'Oncologia Hospital Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Universidad de Navarra
Pamplona Navarra, 31008, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

26

Study ID:

NCT04244656

Recruitment Status:

Active, not recruiting

Sponsor:


CRISPR Therapeutics AG

How clear is this clinincal trial information?

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