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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04244656
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
CRISPR Therapeutics ( CRISPR Therapeutics AG )

Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Biological: CTX120 Phase 1

Detailed Description:
The study may enroll approximately 80 subjects in total.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: CTX120
Administered by IV infusion following lymphodepleting chemotherapy.
Biological: CTX120
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.




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. Overall Survival [ Time Frame: From date of CTX120 infusion until date of death due to any cause, assessed up to 60 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Clinical Trials +1 877-214-4634 MedicalAffairs@crisprtx.com

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Knight Navigators       navigators@ohsu.edu   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: AskSarah    615-329-7274      
Australia, New South Wales
Royal Prince Alfred Hospital Recruiting
Sydney, New South Wales, Australia, 2050
Contact: Christine Contacos       Christine.Contacos@health.nsw.gov.au   
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Canada, Ontario
University Health Network, Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 1X6
Spain
Institut Catala d'Oncologia Hospital Germans Trias i Pujol Recruiting
Badalona, Barcelona, Spain, 08916
Universidad de Navarra Recruiting
Pamplona, Navarra, Spain, 31008
Contact: Maite San Miguel       eecc@unav.es   
Hospital Universitario de Salamanca Recruiting
Salamanca, Spain, 37007
Sponsors and Collaborators
CRISPR Therapeutics AG
Investigators
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Study Director: Ewelina Morawa, MD CRISPR Therapeutics
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Responsible Party: CRISPR Therapeutics AG
ClinicalTrials.gov Identifier: NCT04244656    
Other Study ID Numbers: CRSP-ONC-002
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CRISPR Therapeutics ( CRISPR Therapeutics AG ):
CAR T
Allogeneic
Multiple myeloma
CRISPR-Cas9
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases