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Relapsed Non-Hodgkin Lymphoma

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

Sponsored by Ruijin Hospital

About this trial

Last updated 2 years ago

Study ID

LYCAR-01

Status

Not yet recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
18 to 70 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 2 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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);

No

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.