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Phase I

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

  • Study HIC#:2000027696
  • Last Updated:07/28/2021

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.

  • Start Date07/19/2021
  • End Date01/31/2027

Trial Purpose and Description

Primary Outcome Measures  :

  1. Part A (dose escalation) [ Time Frame: From CTX130 infusion up to 28 days post-infusion ]Incidence of adverse events
  2. Part B (cohort expansion) [ Time Frame: From CTX130 infusion up to 60 months post-infusion] ]Objective response rate

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.

Sub-Investigators

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