A Safety and Efficacy Study Evaluating CTX120 in Subjects With Relapsed or Refractory Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04244656|
Recruitment Status : Active, not recruiting
First Posted : January 28, 2020
Last Update Posted : July 18, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Biological: CTX120||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 22, 2020|
|Estimated Primary Completion Date :||November 2026|
|Estimated Study Completion Date :||January 2027|
Administered by IV infusion following lymphodepleting chemotherapy.
CTX120 B-cell maturation antigen (BCMA)-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.
- Part A (dose escalation): Incidence of adverse events [ Time Frame: From CTX120 infusion up to 28 days post-infusion ]Adverse events defined as dose-limiting toxicities
- Part B (cohort expansion): Objective response rate [ Time Frame: From CTX120 infusion up to 60 months post-infusion ]Objective response rate per International Myeloma Working Group (IMWG) response criteria.
- 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 ]
- Overall Survival [ Time Frame: From date of CTX120 infusion until date of death due to any cause, assessed up to 60 months ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04244656
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Tennessee|
|Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|
|Australia, New South Wales|
|Royal Prince Alfred Hospital|
|Sydney, New South Wales, Australia, 2050|
|Peter MacCallum Cancer Centre|
|Melbourne, Victoria, Australia, 3000|
|University Health Network, Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 1X6|
|Institut Catala d'Oncologia Hospital Germans Trias i Pujol|
|Badalona, Barcelona, Spain, 08916|
|Universidad de Navarra|
|Pamplona, Navarra, Spain, 31008|
|Hospital Universitario de Salamanca|
|Salamanca, Spain, 37007|
|Study Chair:||Sarah Cohen, MD||CRISPR Therapeutics|
|Responsible Party:||CRISPR Therapeutics AG|
|Other Study ID Numbers:||
|First Posted:||January 28, 2020 Key Record Dates|
|Last Update Posted:||July 18, 2022|
|Last Verified:||July 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases