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Safety and Efficiency Study of CD19-PD1-CART Cell in Relapsed/Refractory B Cell Lymphoma

NCT04163302 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-11-15

No results posted yet for this study

Summary

This is a single center, non-randomized, open-label, phase 2 study to evaluate the efficacy and safety of CD19-PD1-CART cells therapy for patients with relapsed/refractory B Cell Lymphoma.

Conditions

  • Lymphoma, B-Cell

Interventions

BIOLOGICAL

CD19-PD1-CART Cell

This study was a single-center, open-label, single-arm, non-randomized clinical trial, which has 3 groups by infusion dose level. Firstly, each dose group has 3 patients. The pretreatment regimen of cyclophosphamide (25mg/m2 for 3 consecutive days) and fludarabine (10mg/kg for 3 consecutive days) was given before CART cells were reinfused. CART cells were reinfused on the third day after the pretreatment. If no serious side effects emerges in the group, then the next group uses the subsequent higher dose. If serious side effects emerges in a single patients in any dose level, 3 more patients will be enrolled to the same dose level. After 9 or more patients, the investigators select the safest dose and recruit more patients for CART test to explore its effectiveness.

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Quanshun Wang · Hainan Hospital of Chinese PLA General Hospital

  • Wengshuai Zheng · Hainan Hospital of Chinese PLA General Hospital

  • Lixun Guan · Hainan Hospital of Chinese PLA General Hospital

  • Lu Wang · Hainan Hospital of Chinese PLA General Hospital

  • Yuanyuan Xu · Hainan Hospital of Chinese PLA General Hospital

  • Yalei Hu · Hainan Hospital of Chinese PLA General Hospital

  • Zhengyang Gu · Hainan Hospital of Chinese PLA General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-07
Primary Completion
2021-07-01
Completion
2022-07-01

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 NCT04163302 on ClinicalTrials.gov