A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)
Leukemia
Non-Hodgkin Lymphoma
18 Years and older, Male and Female
CRSP-ONC-001 (primary)
NCI-2019-07066
Summary
This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of
CTX110 in subjects with relapsed or refractory B-cell malignancies.
Objectives
The study may enroll up to 227 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).
Eligibility
- 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.
Treatment Sites in Georgia
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