A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)
- For NHL patients: Age ≥18 years. For B cell ALL patients: age ≥18 years to ≤70 years
- Refractory or relapsed non-Hodgkin lymphoma, as evidenced by 2 or more lines of prior therapy, or histologically confirmed B cell ALL, refractory or relapsed.
- 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.
- For NHL patients: prior allogeneic HSCT. For B cell ALL patients: prior allogeneic HSCT within 6 months, and/or any evidence of GvHD.
- 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.
- For NHL patients: Use of systemic anti-tumor therapy or investigational agent within 14 days or 5 half-lives, whichever is longer, of enrollment. For B cell ALL patients: Use of systemic antitumor therapy within 7 days of enrollment.
- Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
- Women who are pregnant or breastfeeding.
The study may enroll up to 143 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).
Trial Phase Phase I
Trial Type Treatment
CRISPR Therapeutics AG
- Primary ID CRSP-ONC-001
- Secondary IDs NCI-2019-07066
- Clinicaltrials.gov ID NCT04035434