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Clinical Trial of ssCART-19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (Including Central Nervous System Infiltration)

NCT06367114 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-04-19

No results posted yet for this study

Summary

This study is a Phase II, single-arm, open-label, non-randomized, dose-escalation clinical trial to evaluate the efficacy and safety of ssCART-19 Cell Injection in the treatment of patients with CD19 positive Relapsed or Refractory acute lymphoblastic leukemia, including central nervous system infiltration.

Conditions

  • Relapsed or Refractory Acute Lymphoblastic Leukemia

Interventions

BIOLOGICAL

ssCART-19

Split-Dose of ssCART-19 cells will be infused, and classic "3+3" dose escalation will be applied.

DRUG

Fludarabine

Fludarabine is used for lymphodepletion.

DRUG

Cyclophosphamide

Cyclophosphamide is used for lymphodepletion.

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    collaborator OTHER

  • Peking University People's Hospital

    collaborator OTHER

  • Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2024-09-30
Completion
2025-12-31

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 NCT06367114 on ClinicalTrials.gov