Skip to main content

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

Trial Status: Active

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.

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.
  • Agree to participate in an additional long-term follow-up study after completion of this study.

Exclusion Criteria

  • 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.

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
San Francisco
University of California San Francisco
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: UCSF Clinical Trials
Phone: 877-827-3222

Florida

Jacksonville
Mayo Clinic in Florida
Status: ACTIVE

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Dana Wheeler
Phone: 913-945-7550

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: ACTIVE
Buffalo
Roswell Park Cancer Institute
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: ACTIVE

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Marcella West Aguilar
Phone: 214-648-1479

Virginia

Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: ACTIVE

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

Lead Organization
CRISPR Therapeutics AG

  • Primary ID CRSP-ONC-001
  • Secondary IDs NCI-2019-07066
  • Clinicaltrials.gov ID NCT04035434