Engineered T-Cell Therapy for Patients With ALPP-Positive Advanced Solid Tumors (NCT07123493) | Clinical Trial Compass
TerminatedEarly Phase 1
Engineered T-Cell Therapy for Patients With ALPP-Positive Advanced Solid Tumors
Stopped: Strategic Portfolio Decision
China1 participantsStarted 2025-08-28
Plain-language summary
This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of ALPP CAR-T cells in patients with ALPP-positive recurrent or metastatic solid tumors who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in solid tumors.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Participants must voluntarily provide written informed consent.
✓. Aged 18-70 years (inclusive).
✓. Life expectancy ≥ 3 months.
✓. ECOG performance status 0-1.
✓. Failed or unsuitable for standard therapy.
✓. At least one measurable lesion per RECIST 1.1.
✓. ALPP-positive tumor confirmed by immunohistochemistry.
✓. Adequate organ and bone marrow function.
Exclusion criteria
✕. Primary CNS malignancy or uncontrolled CNS metastases.
✕. Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ).
✕. Active autoimmune disease or history of autoimmune disease.
What they're measuring
1
Incidence of Adverse Events of ALPP CAR-T cells [Safety and Tolerability]
Timeframe: Up to 24 months
2
Incidence of Dose Limiting Toxicity of ALPP CAR-T cells [Safety and Tolerability]