Tumor Microenvironment Mechanism of LY007 for r/r B-NHL and the Exploration of Novel CAR-T Translational Research

NCT ID: NCT06049381

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-12-31

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 proliferation, and to explore the mechanisms: before single harvesting, before bridging, before pretreatment, D0, D7, D14, D21, D28, and at the time of follow-up evaluation (plus time points if taking BTKi inhibitors: Peripheral blood specimens were collected before BTKi and 48h after BTKi discontinuation, and peripheral blood cells from patients before and after treatment were analyzed by mass spectrometry flow and single-cell sequencing.

Tumor tissue specimens were collected from patients at different time points (before pretreatment, during CAR-T expansion, and at PD) and subjected to single-cell sequencing.

Conditions

Relapsed Non-Hodgkin Lymphoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients receive LY007 CD20 CAR-T

No interventions assigned to this group

Patients receive commerial CD19 CAR-T in China

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhao Weili

Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Zixun Yan, Doctor

Role: CONTACT

yzx12119@rjh.com.cn

+862164370045 ext. 610707

Other Identifiers

LYCAR-01

Identifier Type: -

Identifier Source: org_study_id