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Clinical Study of CAR-T Technology for the Treatment of Relapsed Refractory Malignant Haematological Tumours

NCT06238336 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-02-02

No results posted yet for this study

Summary

The trial is designed as an early exploratory single-centre, open, single-arm clinical trial. The trial is planned to evaluate the safety and efficacy of CAR-T for the treatment of relapsed refractory malignant haematological tumours. The trial is divided into five visit periods as follows: screening period, non-myeloablative pretreatment, short-term follow-up period, mid-term follow-up period and exit visit.

Conditions

  • Hematological Malignancy

Interventions

DRUG

CAR-T cell therapy

The application of CAR-T therapy in the clinic generally involves the in vitro preparation and in vivo infusion of CAR-T, and the specific experimental process is divided into five steps: (1) isolation of T cells from the peripheral blood of the cancer subjects or single harvested single nucleated cells; (2) use of genetic engineering to transfer CAR structural genes that can specifically recognise the tumour cells into the T cells; (3) in vitro cultivation and expansion of CAR-T cells to the desired infusion dose (4) Non-myeloablative chemotherapy is administered prior to the infusion of CAR-T cells, which is used to remove immunosuppressive cells and reduce the tumour load so as to enhance the efficacy of the treatment; (5) CAR-T cells are infused according to the expected dosage, and the efficacy of the treatment is observed and the adverse reactions are closely monitored.

Sponsors & Collaborators

  • Shanxi Bethune Hospital

    lead OTHER

Principal Investigators

  • Xiaomin Zhang · Shanxi Bethune Hospital

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
2020-06-15
Primary Completion
2025-11-15
Completion
2025-12-20

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 NCT06238336 on ClinicalTrials.gov