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A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)

Status
Active
Cancer Type
Leukemia
Non-Hodgkin Lymphoma
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04035434
Protocol IDs
CRSP-ONC-001 (primary)
NCI-2019-07066
Study Sponsor
CRISPR Therapeutics AG

Summary

This is an open-label, multicenter, Phase 1 study evaluating the safety and efficacy of
CTX110 in subjects with relapsed or refractory B-cell malignancies.

Objectives

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).

Eligibility

  1. For NHL patients: Age =18 years. For B cell ALL patients: age =18 years to =70 years
  2. 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.
  3. Eastern Cooperative Oncology Group performance status 0 or 1.
  4. Adequate renal, liver, cardiac and pulmonary organ function
  5. 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.
  6. Agree to participate in an additional long-term follow-up study after completion of this study.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.