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A prospective study of Hi-TCR-T cells targeting Nectin-4/NKG2DL/FAP (secreting IL7, super IL15, CCL21, anti-PD-1 scFv, anti-TGF1 scFv) in locally advanced/metastatic bladder cancer

Single-arm prospective treatment of Nectin-4/NKG2DL/FAP-targeted Hi-TCR-T cells (secreting IL7, super IL15, CCL21, anti-PD-1 scFv, anti-TGF1 scFv) in locally advanced/metastatic bladder cancer

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062548
Enrollment
Unknown
Registered
2022-08-11
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Bladder Cancer

Interventions

Sponsors

The Seventh Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old, the upper limit is 75 years old. 2. ECOG score 0-3; 3. Patients with pathologically or cytologically confirmed, unresectable, advanced metastatic or relapsed or refractory solid malignant tumors, who are ineffective to first-line standard treatment, and have at least one measurable lesion. 4. Nectin4, NKG2DLs, and FAP positive (immunohistochemistry or flow cytometry); 5. Heart, liver, and kidney function: creatinine = 50%; 6. Have a sufficient understanding and voluntarily sign the informed consent; 7. Patients of childbearing potential must be willing to use contraceptive methods.

Exclusion criteria

Exclusion criteria: 1. Have a history of other tumors; 2. Received cytotoxic drugs and glucocorticoids within 2 weeks before cell collection; 3. Active autoimmune disease; 4. Uncontrolled active infection; 5. HIV infection, uncontrolled HBV, HCV, syphilis infection.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate(ORR);Duration of Overall Response(DOR);progression-free survival(PFS);disease control rate(DCR);Overall Survival(OS);

Secondary

MeasureTime frame
Incidence of side effects;

Countries

China

Contacts

Public ContactPang Jun

The Seventh Affiliated Hospital, Sun Yat-Sen University

pangjun530@qq.com+86 18802044177

Outcome results

None listed

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