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A Study of CAR T-Cells in Relapsed/Refractory Hematologic Malignancy

NCT06756321 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-01-03

No results posted yet for this study

Summary

This study is a single-center, open-label clinical trial of single-dose of CAR T-cells in subjects with relapsed/refractory hematologic malignancy.

Conditions

  • Relapsed/refractory Lymphoma
  • Relapsed/Refractory Leukemia

Interventions

BIOLOGICAL

anti-CD19-CAR T-cells, or anti-CD30-CAR T-cells, or anti-CD20/CD30-CAR T-cells

Each subject will be infused with single dose. A classic "3+3" dose escalation will be employed. anti-CD19-CAR T-cells Dose level 1：1x10\^5 CAR T cells/kg, Dose level 2：3x10\^5 CAR T cells/kg, Dose level 3：1x10\^6 CAR T cells/kg anti-CD30-CAR T-cells Dose level 1：3x10\^6 CAR T cells/kg, Dose level 2：6x10\^6 CAR T cells/kg, Dose level 3：1x10\^7 CAR T cells/kg anti-CD20/CD30-CAR T-cells Dose level 1：1x10\^6 CAR T cells/kg, Dose level 2：3x10\^6 CAR T cells/kg, Dose level 3：1x10\^7 CAR T cells/kg

DRUG

Fludarabine

Fludarabine will be given at a dose of 25 mg/m\^2/day intravenously (IV) for 3 days prior to the infusion of CAR T-cells.

DRUG

Cyclophosphamide

Cyclophosphamide will be given at a dose of 250 mg/m\^2/day intravenously (IV) for 3 days prior to the infusion of CAR T-cells.

Sponsors & Collaborators

  • Shanghai First Song Biotechnology Co., LTD

    collaborator INDUSTRY

  • Affiliated Hospital of Nantong University

    lead OTHER

Principal Investigators

  • Hong Liu, MD · Affiliated Hospital of Nantong University

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
2023-09-18
Primary Completion
2025-03-18
Completion
2026-03-18

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 NCT06756321 on ClinicalTrials.gov