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:12/22/2022
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.
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Trial Purpose and Description
Primary Outcome Measures :
- Part A (dose escalation) [ Time Frame: From CTX130 infusion up to 28 days post-infusion ]Incidence of adverse events
- Part B (cohort expansion) [ Time Frame: From CTX130 infusion up to 60 months post-infusion] ]Objective response rate
Inclusion Criteria (abbreviated):
- Age ≥18 years and body weight ≥60 kg.
- Confirmed diagnosis of a T cell malignancy or Diffuse Large B-Cell Lymphoma (DLBCL).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Adequate renal, liver, cardiac, and pulmonary organ function.
- 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):
- Prior allogeneic stem cell transplant (SCT).
- Prior treatment with any anti-CD70 targeting agents.
- History of certain central nervous system (CNS), cardiac or pulmonary conditions.
- Active HIV, hepatitis B virus or hepatitis C virus infection.
- 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.
- Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
- Prior solid organ transplantation.
- Pregnant or breastfeeding females.