NCT04035434

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

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 (CARBON)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: CRISPR Therapeutics AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an 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 227 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).

Conditions

• B-cell Malignancy
• Non-Hodgkin Lymphoma
• B-cell Lymphoma
• Adult B Cell ALL

Interventions

Type	Name	Description
BIOLOGICAL	CTX110	CTX110 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components

Timeline

• Start date: 2019-07-22
• Primary completion: 2024-10-04
• Completion: 2024-10-04
• First posted: 2019-07-29
• Last updated: 2025-10-24
• Results posted: 2025-10-24

Locations

33 sites across 6 countries: United States, Australia, Canada, France, Germany, Spain

Regulatory

• FDA-regulated drug study