Clinical Trials /

A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies

NCT04502446

Description:

This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory T or B cell malignancies.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • T-cell Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies
  • Official Title: A Phase 1, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX130) in Subjects With Relapsed or Refractory T or B Cell Malignancies

Clinical Trial IDs

  • ORG STUDY ID: CRSP-ONC-004
  • NCT ID: NCT04502446

Conditions

  • T Cell Lymphoma

Interventions

DrugSynonymsArms
CTX130CTX130

Purpose

This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory T or B cell malignancies.

Detailed Description

      The study may enroll approximately 45 subjects in total.
    

Trial Arms

NameTypeDescriptionInterventions
CTX130ExperimentalAdministered by IV infusion following lymphodepleting chemotherapy.
  • CTX130

Eligibility Criteria

        Inclusion Criteria (abbreviated):

          1. Age ≥18 years and body weight ≥60 kg.

          2. Confirmed diagnosis of a T cell malignancy or Diffuse Large B-Cell Lymphoma (DLBCL).

          3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

          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
             CTX130 infusion.

        Exclusion Criteria (abbreviated):

          1. Prior allogeneic stem cell transplant (SCT).

          2. Prior treatment with any anti-CD70 targeting agents.

          3. History of certain central nervous system (CNS), cardiac or pulmonary conditions.

          4. Active HIV, hepatitis B virus or hepatitis C virus infection.

          5. Previous or concurrent malignancy, except treated with curative approach not requiring
             systemic therapy and in remission for >12 months, or any other localized malignancy
             with low risk of developing into metastatic disease.

          6. Primary immunodeficiency disorder or active autoimmune disease requiring steroids
             and/or other immunosuppressive therapy.

          7. Prior solid organ transplantation.

          8. Pregnant or breastfeeding females.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Part A (dose escalation)
Time Frame:From CTX130 infusion up to 28 days post-infusion
Safety Issue:
Description:Incidence of adverse events

Secondary Outcome Measures

Measure:Progression Free Survival
Time Frame:From date of CTX130 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 CTX130 until date of death due to any cause, assessed up to 60 months
Safety Issue:
Description:

Details

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

Trial Keywords

  • CAR T
  • Allogeneic
  • Lymphoma

Last Updated

August 4, 2020