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Clinical Study of Autologous Stem Cell Transplantation + Anti-CD19 CAR T Cells for B-cell Lymphoma

NCT05755828 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-03-06

No results posted yet for this study

Summary

To evaluate the CR rate of B-NHL subjects who achieved PR at intermediate assessment after first-line chemotherapy treated with autologous stem cell transplantation + Anti-CD19 CAR T cells.

Conditions

Interventions

BIOLOGICAL

ASCT+CAR-T Cell Infusion

CD19 CAR-T cells were prepared from peripheral lymphocytes of NHL patients with PR after 3 to 4 courses of chemotherapy, and autologous stem cells were collected and frozen after mobilization of patient stem cells by granulocyte stimulating factor (10μg/kg/d\*5d). BEAM pretreatment was performed. Autologous stem cells were injected 24 h after pretreatment, and the number of CD34+ cells was \> 2\*106/kg. On the 6th day after transplantation, autologous Anti-CD19 CAR T cells were transfused, and the dose was determined by the investigator according to the subjects' own disease conditions and in vitro preparation. The patients were given constant intravenous drip/push infusion for 30 minutes.

Sponsors & Collaborators

  • The Affiliated Hospital of Xuzhou Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2024-12-01
Completion
2024-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05755828 on ClinicalTrials.gov