Clinical Trials /

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

NCT04035434

Description:

This is a single-arm, open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies.

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies
  • Official Title: A Phase 1/2 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

Clinical Trial IDs

  • ORG STUDY ID: CRSP-ONC-001
  • NCT ID: NCT04035434

Conditions

  • B-cell Malignancy
  • Non-Hodgkin Lymphoma
  • B-cell Lymphoma

Interventions

DrugSynonymsArms
CTX110CTX110

Purpose

This is a single-arm, open-label, multicenter, Phase 1/2 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 95 subjects in total.
    

Trial Arms

NameTypeDescriptionInterventions
CTX110ExperimentalAdministered by IV infusion following lymphodepleting chemotherapy.
  • CTX110

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities
Time Frame:From CTX110 infusion up to 28 days post-infusion
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:Duration of Response (DOR) will only be reported for subjects who have had CR/PR events
Measure: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
Safety Issue:
Description:
Measure:Overall Survival
Time Frame:From date of CTX110 infusion until date of death due to any cause, assessed up to 60 months
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:CRISPR Therapeutics AG

Trial Keywords

  • CAR T
  • Non-Hodgkin Lymphoma
  • NHL
  • Lymphoma
  • Allogeneic

Last Updated

December 6, 2019