Relapsed or Refractory B-cell Lymphomas Clinical Trial
Official title:
The Clinical Research of Anti-CD20 CAR-T Cells in Patients With Refractory or Relapsed B Lymphocyte Lymphoma
The present study is an exploratory study. Patients who meeting the enrollment conditions for relapsed or refractory B-cell lymphoma receive a single intravenous dose of CD20-CART cells. The research with the open-label, single arm running control methods in order to initially observe the safety, tolerability, and cellular pharmacokinetics of CD20-CART cell drugs.
The main purpose:
To preliminary explore the safety, tolerability and cellular pharmacokinetics of CD20-CART
cell agents in the treatment of relapsed or refractory B-cell lymphomas.
The Secondary purpose:
The following indicators for preliminary observations of CD20-CART cells in the treatment of
relapsed or refractory B-cell malignant lymphoma.
1. The determination of lymph nodes to evaluate the anti-tumor effect caused by the input
of CD20-CART cells agents.
2. Assessing the ability of CD20-CART cell agents to inhibit the migration of bone marrow
and lymph node tumor foci.
3. Assess the killing ability of CD20-CART cell agents to tumor cells in vitro, for
patients whose tumor cells could obtain.
4. Disease control rate (DCR) (=CR (complete disease remission) + PR (partial remission of
disease) + SD (stable disease), short-term efficacy assessment); Overall survival (OS)
and progression-free survival (PFS) (long-term efficacy assessment).
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