Evaluating CTX112 for B-cell malignancies

A Phase 1/2, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Subjects With Relapsed or Refractory B Cell Malignancies

This study is testing a new type of CAR T cell therapy called CTX112 to see if it can safely help people with tough-to-treat B-cell cancers.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CRISPR Therapeutics (industry)
• Drugs / interventions: chimeric antigen receptor, immunotherapy
• Locations: 7 sites (Westwood, Kansas and 6 other locations)
• Trial ID: NCT05643742 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase 1/2 study assesses the safety and efficacy of CTX112, an allogeneic CAR T cell immunotherapy, in patients with relapsed or refractory B-cell malignancies. CTX112 is created using CRISPR-Cas9 gene editing to modify T cells to target CD19. The study aims to determine how well this treatment works and its safety profile in a diverse patient population across multiple research sites.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with refractory or relapsed B-cell malignancies and good overall health.

Not a fit: Patients with a history of central nervous system involvement by malignancy or those with active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell malignancies.

How similar studies have performed: Other studies using CAR T cell therapies have shown promising results, indicating that this approach has potential for success.

Eligibility criteria

Key Inclusion Criteria:

1. Age ≥18 years.
2. Refractory or relapsed B cell malignancy.
3. Eastern Cooperative Oncology Group performance status 0 or 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 CTX112 infusion.

Key Exclusion Criteria:

1. Prior allogeneic hematopoietic stem cell transplant (HSCT).
2. Active or history of central nervous system (CNS) involvement by malignancy.
3. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
4. Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.
5. Active HIV, hepatitis B virus or hepatitis C virus infection.
6. Previous or concurrent malignancy in the last 3 years (with the exception of non-melanoma skin cancer and other cancers deemed by the investigator and medical monitor to be of low likelihood for recurrence).
7. Concurrent systemic treatment with an anticancer biologic (e.g., monoclonal antibody) within 30 days prior to CTX112 infusion or with a nonbiological anticancer drug within 14 days prior to CTX112 infusion.
8. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
9. Women who are pregnant or breastfeeding.

Where this trial is running

Westwood, Kansas and 6 other locations

• University of Kansas — Westwood, Kansas, United States (RECRUITING)
• Washington University — St Louis, Missouri, United States (RECRUITING)
• SCRI — San Antonio, Texas, United States (RECRUITING)
• University of Utah — Salt Lake City, Utah, United States (RECRUITING)
• Royal Prince Alfred — Camperdown, New South Wales, Australia (RECRUITING)
• Alfred Health — Melbourne, Victoria, Australia (RECRUITING)
• Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia (RECRUITING)

Study contacts

• Study coordinator: Clinical Trials

Conditions: B-cell Lymphoma, Non-Hodgkin Lymphoma, B-cell Malignancy, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Large B-cell Lymphoma