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Anti-CD19 FasT CAR-T Cell Therapy for B Cell NHL

NCT04638270 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-11-20

No results posted yet for this study

Summary

Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies. To make a further improvement, adapting the FasT CAR-T cells manufacture technology to shorten the manufacturing time and maintain the stemness of CAR-T cells. We launch such a clinical trial using CD19 targeted CAR-T cells for patients with relapsed and refractory B-cell NHL to evaluate the efficacy and safety of CD19 targeted CAR-T cell therapy.

Conditions

  • Lymphoma, Non-Hodgkin

Interventions

BIOLOGICAL

anti-CD19 FasT CAR-T cells

Treatment follows a lymphodepletion, chemotherapy regimen that consists of Fludarabine (30 mg/m2 per day) and Cyclophosphamide (500mg/m2 per day) for 3 days prior to cell infusion.

Sponsors & Collaborators

  • Gracell Biotechnologies (Shanghai) Co., Ltd.

    collaborator INDUSTRY

  • 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

    collaborator OTHER

  • The Second Affiliated Hospital of Chongqing Medical University

    collaborator OTHER

  • The Affiliated Hospital Of Guizhou Medical University

    collaborator OTHER

  • The Second Affiliated Hospital of Kunming Medical University

    collaborator OTHER

  • Chongqing University Cancer Hospital

    collaborator OTHER

  • Xinqiao Hospital of Chongqing

    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
2020-11-21
Primary Completion
2021-11-01
Completion
2023-11-01

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 NCT04638270 on ClinicalTrials.gov