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TP53 R248Q TCR-T Cell Therapy for Advanced Solid Tumor

NCT06619886 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-10-01

No results posted yet for this study

Summary

To evaluate the safety and efficacy of T cell therapy with mutated TP53 R248Q specific TCR transduction in patients with advanced solid tumor expressing the TP53 R248Q mutation and the HLA-A\*11:01 allele.

Conditions

Interventions

BIOLOGICAL

Autologous, engineered T Cells targeting TP53 R248Q

TP53-R248Q mutant TCR-T Cells Injection, 28 days as a treatment cycle (cycle number N≤3), each cycle was divided into three D0, D7, D14 infusion, a total of 3 dose groups were set up, the single infusion of cells within the range of ±20% all meet the requirements

Sponsors & Collaborators

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Qi Li, Prof. · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-09-24
Primary Completion
2026-10-31
Completion
2027-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06619886 on ClinicalTrials.gov