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A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)

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: NCT04035434
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
CRISPR Therapeutics ( CRISPR Therapeutics AG )

Tracking Information
First Submitted Date  ICMJE July 22, 2019
First Posted Date  ICMJE July 29, 2019
Last Update Posted Date January 8, 2021
Actual Study Start Date  ICMJE July 22, 2019
Estimated Primary Completion Date July 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2020)
  • Part A (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities [ Time Frame: From CTX110 infusion up to 28 days post-infusion ]
  • Part B (Cohort Expansion): Objective response rate [ Time Frame: From CTX110 infusion up to 60 months post-infusion ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2019)
  • Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities [ Time Frame: From CTX110 infusion up to 28 days post-infusion ]
  • Phase 2 (Cohort Expansion): Objective response rate [ Time Frame: From CTX110 infusion up to 60 months post-infusion ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2019)
  • Duration of Response [ Time Frame: From date of first objective response of CR/PR until date of disease progression or death due to any cause, assessed up to 60 months ]
    Duration of Response (DOR) will only be reported for subjects who have had CR/PR events
  • Progression Free Survival [ Time Frame: From date of CTX110 infusion until date of disease progression or death due to any cause, assessed up to 60 months ]
  • Overall Survival [ Time Frame: From date of CTX110 infusion until date of death due to any cause, assessed up to 60 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)
Official Title  ICMJE A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9-Engineered T Cells (CTX110) in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)
Brief Summary This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies.
Detailed Description The study may enroll up to 131 subjects in total.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • B-cell Malignancy
  • Non-Hodgkin Lymphoma
  • B-cell Lymphoma
Intervention  ICMJE Biological: CTX110
CTX110 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components
Study Arms  ICMJE Experimental: CTX110
Administered by IV infusion following lymphodepleting chemotherapy.
Intervention: Biological: CTX110
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 20, 2020)
131
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2019)
95
Estimated Study Completion Date  ICMJE August 2026
Estimated Primary Completion Date July 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Age ≥18 years.
  2. Refractory or relapsed non-Hodgkin lymphoma, as evidenced by 2 or more lines of prior 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 CTX110 infusion.
  6. Agree to participate in an additional long-term follow-up study after completion of this study.

Key Exclusion Criteria:

  1. Treatment with any gene therapy or genetically modified cell therapy, including CAR T cells.
  2. Prior allogeneic HSCT.
  3. History of central nervous system (CNS) involvement by malignancy
  4. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
  5. Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.
  6. Active HIV, hepatitis B virus or hepatitis C virus infection.
  7. 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.
  8. Use of systemic anti-tumor therapy or investigational agent within 14 days or 5 half-lives, whichever is longer, of enrollment.
  9. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
  10. Women who are pregnant or breastfeeding.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials +1 (877) 214-4634 MedicalAffairs@crisprtx.com
Listed Location Countries  ICMJE Australia,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04035434
Other Study ID Numbers  ICMJE CRSP-ONC-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CRISPR Therapeutics ( CRISPR Therapeutics AG )
Study Sponsor  ICMJE CRISPR Therapeutics AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ewelina Morawa, MD CRISPR Therapeutics
PRS Account CRISPR Therapeutics
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP