Clinical Trials Directory

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UnknownNCT03576807

The Clinical Research of Anti-CD20 CAR-T Cells in Patients With Refractory or Relapsed B Lymphocyte Lymphoma

Status
Unknown
Phase
Phase 1
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Xin Wang · Academic / Other
Sex
All
Age
10 Years – 80 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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).

Conditions

Interventions

TypeNameDescription
DRUGCD20 CAR-T cellsA total of 1 - 20×10\^6 CD20 CAR-T cells/kg will be administered by IV infusions.

Timeline

Start date
2018-04-04
Primary completion
2019-04-03
Completion
2020-04-03
First posted
2018-07-03
Last updated
2018-07-03

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03576807. Inclusion in this directory is not an endorsement.