Status:
UNKNOWN
Tumor Microenvironment Mechanism of LY007 for r/r B-NHL and the Exploration of Novel CAR-T Translational Research
Lead Sponsor:
Ruijin Hospital
Conditions:
Relapsed Non-Hodgkin Lymphoma
Eligibility:
All Genders
18-70 years
Brief Summary
The T cell characteristics of 12 patients treated with CD20 CAR-T (LY007 cell injection) were analyzed to study their relationship with CAR-T anti-tumor activity, tumor killing, and in vivo proliferat...
Eligibility Criteria
Inclusion
- 18-70 years of age (include 18 and 70);
- Eastern Cooperative Oncology Group (ECOG) score of 0-1;
- Cytologically or histologically confirmed diagnosis of CD20-positive B-NHL according to WHO 2016 criteria, including diffuse large B-cell lymphoma (including histologically transformed) and transformed follicular lymphoma (TFL);
- Relapsed or refractory B-cell non-Hodgkin's lymphoma, subjects must have been treated with at least anthracyclines and rituximab (or other CD20-targeted agents) and have relapsed, failed to remit, or progressed after at least second-line therapy or autologous hematopoietic stem cell transplantation (auto-HSCT);
Exclusion
- Hepatitis B surface antigen (HBsAg) positive or Hepatitis B core antibody (HBcAb) positive with peripheral blood HBV DNA titer higher than the lower limit of detection; Hepatitis C virus (HCV) antibody positive with HCVRNA titer higher than the lower limit of detection; Human Immunodeficiency Virus (HIV) antibody positive; Positive syphilis serology. 2. Lymphoma involving only the central nervous system (CNS) (subjects with secondary CNS lymphoma are permitted to enroll); and
- Lymphoma involving only the central nervous system (CNS) (subjects with secondary CNS lymphoma are eligible for enrollment). 3. prior CARB vaccination prior to enrollment;
- Prior CAR-T therapy (except for prior targeted CD19 CAR-T therapy, including patients with stable disease evaluated at 3 months after CD19 CAR-T infusion or progressive disease evaluated at any time) or other genetically modified T-cell therapy prior to monotherapy.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06049381
Start Date
October 1 2023
End Date
December 31 2025
Last Update
September 22 2023
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