Evaluating CTX112 for B-cell malignancies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Clinical Trials
• Email: MedicalAffairs@crisprtx.com
• Phone: +1 (877) 214-4634

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Treatment for relapsed or refractory B-cell lymphoma using SynKIR-310

  This study is testing a new treatment called SynKIR-310 to see if it can help adults with relapsed or refractory B-cell lymphoma feel better.

  Recruiting at 5 sites Phase 1 Verismo Therapeutics · Denver, Colorado and 4 other locations · NCT06544265

• Gene therapy for certain blood cancers

  This study is testing a new gene therapy called VNX-101 to see if it can help people with certain types of blood cancers that haven't responded to other treatments.

  Recruiting at 11 sites Phase 1/2 Vironexis Biotherapeutics Inc. · Duarte, California and 10 other locations · NCT06533579

• Oral AS-1763 treatment for patients with certain blood cancers

  This study is testing a new oral medication called AS-1763 to see if it can help patients with certain blood cancers who haven't had success with other treatments.

  Recruiting at 13 sites Phase 1 Carna Biosciences, Inc. · Orange, California and 12 other locations · NCT05602363

• Treatment for B-cell malignancies using BGB-16673

  This study is testing a new drug called BGB-16673 to see if it can safely help people with different types of B-cell cancers.

  Recruiting at 29 sites Phase 1/2 BeOne Medicines · Bengbu, Anhui and 28 other locations · NCT05294731

• Exploring BGB-16673 for treating B-cell malignancies

  This study is testing a new drug called BGB-16673 to see if it can safely help people with certain types of B-cell cancers, like Marginal Zone Lymphoma and Follicular Lymphoma, who haven't had success with other treatments.

  Recruiting at 104 sites Phase 1/2 BeOne Medicines · Birmingham, Alabama and 113 other locations · NCT05006716

• Rituximab and Tafasitamab with Allogeneic NK Cells for relapsed or refractory B-cell NHL

  This trial tests whether giving allogeneic NK cells with Rituximab, Tafasitamab, and IL-2 can help people with relapsed or refractory B-cell non-Hodgkin lymphoma who have tried at least two prior therapies.

  Recruiting Phase 1 Case Comprehensive Cancer Center · Cleveland, Ohio and 1 other locations · NCT07225439

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.