A Study To Evaluate CTX110 In Subjects With Relapsed Or Refractory B-Cell Malignancies

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness CTX110 in subjects with relapsed or refractory B cell malignancies.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years old.
  • Refractory or relapsed non-Hodgkin lymphoma, as evidenced by 2 or more lines of prior  therapy.  
  • 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.
  • Prior allogeneic HSCT.  
  • 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.
  • Use of systemic anti-tumor therapy or investigational agent within 14 days or 5 half-lives, whichever is longer, of enrollment.  
  • Primary immunodeficiency disorder or active autoimmune disease requiring steroids  and/or other immunosuppressive therapy.   
  • Women who are pregnant or breastfeeding.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Hemant Murthy, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions