A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies
This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies.
- B-cell Malignancy
- Non-Hodgkin Lymphoma
- B-cell Lymphoma
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Age ≥18 years.
- Refractory or relapsed non-Hodgkin lymphoma, as evidenced by 2 or more lines of prior therapy.
- Eastern Cooperative Oncology Group performance status 0 or 1.
- Adequate renal, liver, cardiac and pulmonary organ function
- 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 CTX110 infusion.
- Agree to participate in an additional long-term follow-up study after completion of this study.
- Treatment with any gene therapy or genetically modified cell therapy, including CAR T cells.
- Prior allogeneic HSCT.
- History of central nervous system (CNS) involvement by malignancy
- History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
- Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.
- Active HIV, hepatitis B virus or hepatitis C virus infection.
- Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥5 years.
- Use of systemic anti-tumor therapy or investigational agent within 14 days or 5 half-lives, whichever is longer, of enrollment.
- Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
- Women who are pregnant or breastfeeding.
- Phase 1
- Study Type
- Intervention Model
- Sequential Assignment
- Primary Purpose
- None (Open Label)
|Administered by IV infusion following lymphodepleting chemotherapy.||
- CRISPR Therapeutics AG
Study ContactClinical Trials
+1 (877) 214-4634
The study may enroll up to 95 subjects in total.