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

Official Title

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)

Summary:

This is an open-label, multicentre, Phase 1 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies.

Trial Description

Primary Outcome:

• Part A (Dose Escalation), for all cohorts: Incidence of adverse events, defined as dose-limiting toxicities
• Part B (Cohort Expansion), for NHL: Objective response rate

Secondary Outcome:

• Duration of Response
• Duration of Clinical Benefit (DOCB)
• Progression Free Survival
• Overall Survival
• Objective Response Rate (for B cell ALL)

The study may enroll up to 143 subjects in total. CTX110 is a CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells prepared for the treatment of B cell malignancies. The cells are from healthy adult volunteer donors that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR-associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).

View this trial on ClinicalTrials.gov