A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD19 Allogeneic CRISPR-Cas9 Engineered T Cells (CTX110) in Subjects With Relapsed or Refractory B Cell Malignancies
The purpose of the study is to learn about the safety and efficacy of CTX110 (study product), an investigational product made from allogeneic T cells that have been modified with gene editing, when infused into patients with a B cell cancer, either Non-Hodgkin lymphoma (NHL), or B cell Acute Lymphoblastic Leukemia (B-ALL). We are hoping to find out if the use of study product in NHL and B-ALL patients is better, worse, or the same as chemotherapy.
Relapsed or Refractory B Cell Malignancies, B-cell non-hodgkin lmphomas, DLBCL, high grade B cell lymphoma, transformed FL, B cell Acute Lymphoblastic Leukemia
- > 18 years of age
- Diagnosed with B-cell cancer: non-Hodgkin lymphomas: DLBCL, high grade B-cell lymphoma, transformed follicular lymphoma, grade 2b follicular lymphoma, or B cell Acute Lymphoblastic Leukemia
- Refractory or relapsed disease
- 2 or more prior lines of therapy
- Either have failed autologous HSCT or ineligible for or refused prior autologous HSCT
- Adequate organ function
- No prior CAR T cell therapy
- No prior allogeneic HSCT
- No history of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system involvment
- Patients cannot have unstable angina, clinically significant arrhythmia, or heart attack in the past 6 months
- No presence of bacterial, viral or fungal infection that is uncontrolled or requires IV anti-infectives.
- Women who are pregnant or breastfeeding
18 - 100
Healthy Volunteers Needed
Duration of Participation
5 years with the requirement to sign on to a separate long term follow up study for an additional 10 years.
Knight Cancer Intake Center: (503) 494-7999
Clinical Trials Information Line: (503) 494-1080 or firstname.lastname@example.org
You will be reimbursed for your study participation, with exact amounts to be determined once the budget has been finalized.
You and your caregiver will receive a debit card that will have money uploaded to it based on the study visits that you complete.