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Preliminary Clinical Study on the Efficacy and Safety of HLA-independent T Cell Receptor-engineered T Cell (Hi-TCR-T) in Therapy of Advanced Refractory Thymic Cancer and Ureteral Cancer

Preliminary Clinical Study on the Efficacy and Safety of HLA-independent T Cell Receptor-engineered T Cell(Hi-TCR-T) in Therapy of Advanced Refractory Thymic Cancer and Ureteral Cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056085
Enrollment
Unknown
Registered
2022-01-31
Start date
2022-03-01
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced refractory thymic cancer and ureteral cancer

Interventions

Experimental group A:Hi-TCR-T cell preparation, Remove lymphocytes, Intravenous reinfusion of cells

Sponsors

Intervention and Cell Therapy Center, Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 18 = 1000/µL and Platelet >= 45000/ µL; 7. Heart, liver and kidney function: creatinine = 50%; 8. Sufficient understanding and voluntary to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Autologous hematopoietic stem cell transplantation has been performed within 6 weeks; 2. Active autoimmune diseases; 3. Uncontrollable active infection; 4. HIV infection, uncontrolled HBV, HCV or syphilis infection; 5. Known tumors of central nervous system.

Design outcomes

Primary

MeasureTime frame
Complete response (CR);Partial response (PR);Stable disease (SD);Progressive disease (PD);Objective response rate (ORR);Duration of response (DOR);Time to progression (TTP);Progression free survival (PFS);Tumor marker(TM);

Secondary

MeasureTime frame
Health-related quality of life(HRQOL);Activity of Hi-TCR-T in vivo;Survival time of Hi-TCR-T in vivo;Hi-TCR-T treatment related inflammatory factors;

Countries

China

Contacts

Public ContactJunhui Chen

Peking University Shenzhen Hospital

chenjhpush@126.com+86 13823161919

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026