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Anti-CD19-CAR-T Cells in Relapsed/Refractory B-cell Tumor Patients.

NCT06375161 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-04-19

No results posted yet for this study

Summary

This study is a single-center, open-label, single-dose clinical trial of anti-CD19-CAR-T cell therapy in relapsed/refractory B-cell tumor patients after Qinglin pre-treatment.

In this study phase, a traditional "3+3" trial design is employed for dose escalation.

Conditions

  • B Cell Malignancies

Interventions

BIOLOGICAL

anti-CD19-CAR-T cells

Before cell infusion, Investigator may decide, based on necessity, whether to administer prophylactic medication, which may include options such as acetaminophen and diphenhydramine, or H1 antihistamines, among others. Subjects are allowed to receive adequate supportive care after anti-CD19-CAR-T cell infusion, including blood transfusions and blood products, antibiotic therapy, antiemetics, antidiarrheals, analgesics, etc.

Sponsors & Collaborators

  • Shanghai Tongji Hospital, Tongji University School of Medicine

    lead OTHER

Principal Investigators

  • Aibin Liang · Shanghai Tongji Hospital, Tongji University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-12-11
Primary Completion
2025-12-10
Completion
2039-12-10

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 NCT06375161 on ClinicalTrials.gov