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Anti-CD19-CAR-T Cells in Subjects With Relapsed/Refractory B Cell Malignancies

NCT06532630 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-02-28

No results posted yet for this study

Summary

This is a single-center, single-arm, open-label, exploratory study to determine the safety, tolerability, feasibility, and preliminary anti-tumor activity of anti-CD19-CAR-T cells in subjects with relapsed/refractory (r/r) B-cell malignancies.

This study plans to enroll patients with relapsed/refractory CD19-positive B-cell malignancies, who will receive a single infusion of anti-CD19-CAR-T cells after screening, PBMC collection, and lymphodepleting chemotherapy.

Conditions

  • B-Cell Malignancy

Interventions

GENETIC

Anti-CD19-CAR-T cells

Each subject will be infused with single dose of anti-CD19-CAR-T cells. A classic "3+3" dose escalation will be employed.

DRUG

Fludarabine

Fludarabine will be given at a dose of 25 mg/m2/day intravenously (IV) for 3 days prior to anti-CD19-CAR-T cells infusion.

DRUG

Cyclophosphamide

Cyclophosphamide will be given at a dose of 250 mg/m2/day intravenously (IV) for 3 days prior to anti-CD19-CAR-T cells infusion.

Sponsors & Collaborators

  • The First Affiliated Hospital of Anhui Medical University

    collaborator OTHER

  • Shanghai First Song Biotechnology Co., LTD

    lead INDUSTRY

Principal Investigators

  • Ge · Thr First Affiliated Hospital of Anhui Medical University

  • Jian Ge, MD · The First Affiliated Hospital of Anhui Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-08-24
Primary Completion
2025-09-01
Completion
2026-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06532630 on ClinicalTrials.gov