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. Key
Treatment Sites in Georgia
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