Non Hodgkin Lymphoma Clinical Trial

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

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.

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Full Description

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).

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

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 Exclusion Criteria:

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.
Positive for HIV, or active 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 CTX110 infusion. For B cell ALL patients: Use of systemic antitumor therapy within 7 days of CTX110 infusion.
Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
Women who are pregnant or breastfeeding.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

227

Study ID:

NCT04035434

Recruitment Status:

Active, not recruiting

Sponsor:

CRISPR Therapeutics AG

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There are 33 Locations for this study

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Cedars Sinai
Los Angeles California, 90048, United States
UCSF Medical Center
San Francisco California, 94143, United States
Mayo Clinic
Jacksonville Florida, 32224, United States
Emory University Winship Cancer Institute
Atlanta Georgia, 30322, United States
University of Chicago
Chicago Illinois, 60637, United States
University of Kansas
Westwood Kansas, 66205, United States
Markey Cancer Center, University of Kentucky
Lexington Kentucky, 40536, United States
University of Maryland
Baltimore Maryland, 21201, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
University of Minnesota
Minneapolis Minnesota, 55455, United States
Washington University
Saint Louis Missouri, 63130, United States
Roswell Park Cancer Insitute
Buffalo New York, 14203, United States
Weill Cornell Medical College / New York Presbyterian Hospital
New York New York, 10021, United States
Duke University
Durham North Carolina, 27710, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Medical Center
Dallas Texas, 75390, United States
Texas Transplant Institute
San Antonio Texas, 78229, United States
Virginia Commonwealth University Massey Cancer Center
Richmond Virginia, 23298, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Royal Prince Alfred Hospital
Sydney New South Wales, 2050, Australia
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia
Sir Charles Gairdner Hospital
Nedlands Western Australia, 6009, Australia
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
CHU de Lille
Lille , 59000, France
Institut Paoli-Calmettes
Marseille , 13009, France
Hôpital Saint Antoine
Paris , 75012, France
University of Hamburg
Hamburg , 20148, Germany
University Hospital Würzburg
Würzburg , 97080, Germany
Clinica Universidad de Navarra
Pamplona Navarra, 31008, Spain
Hospital Clínic de Barcelona
Barcelona , 08036, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

227

Study ID:

NCT04035434

Recruitment Status:

Active, not recruiting

Sponsor:


CRISPR Therapeutics AG

How clear is this clinincal trial information?

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