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A Clinical Study to Evaluate Safety, Tolerance, Pharmacokinetics and Efficacy of Sc610 Injection for Treating Advanced Urinary System Tumors

NCT05633589 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-12-01

No results posted yet for this study

Summary

This is an phase I/IIa, open-lable, single-arm, single-dose escalation and multiple-dose extention clinical study of cell therapy designed to observe and evaluate the tolerance, the pharmacokinetic characteristics, the safety and the efficacy of Sc610 cell injection in the treatment of advanced tumor of urinary system.

Conditions

  • Malignant Tumor of Urinary System (Disorder)

Interventions

BIOLOGICAL

Sc610 cell injection

Peripheral blood mononuclear cells (PBMCs) obtained via apheresis are used for cell product preparation. PD-1 positive T cells are isolated from PBMCs, are transduced with lentivirus loaded with "enhanced receptor" and "amplification factor", and cell quantity are amplified. The obtained Sc610 is used for one-time intravenous infusion.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Hai Huang, Dr. · Department of Urology Surgery, Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2024-05-30
Completion
2024-10-30

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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 NCT05633589 on ClinicalTrials.gov