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Cytoplasmic Activated PD-1 CAR T Cells in Refractory/Relapsed B Cell Lymphoma

NCT03540303 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-05-30

No results posted yet for this study

Summary

Evaluation of the safety and efficacy of CAR19 T cells carrying cytoplasmic activated PD1 in patients with refractory relapsed B-cell lymphoma

Conditions

  • Relapsed Non Hodgkin Lymphoma

Interventions

DRUG

CAR19 T cells carrying cytoplasmic activated PD-1

step 1: Collect 50-100ml of peripheral blood for culture of CAR19 T cells carrying cytoplasmic activated PD-1 step 2. After 72 hours, pretreated with FC regimen, details as follow Cyclophosphamide 600-800mg/m2 for 2 days Fludarabine 25-30mg/m2 for 3 days step 3: After another 48 hours transfusion the cells back to the patients the numbers of infused CAR T cells are 2x106 /kg for the first 3 patients, 6x106 /kg for the second 3 patients and 18x106 /kg for the third 3 patients. After finishing this, another 6 patients will be enrolled for observation of efficacy.

Sponsors & Collaborators

  • The Pregene (ShenZhen) Biotechnology Company, Ltd.

    collaborator INDUSTRY

  • Henan Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Yongping Song, M.D · Henan Cancer Hospital

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-12
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03540303 on ClinicalTrials.gov