Clinical trial · Interventional
Engineered T-Cell Therapy for Patients With ALPP-Positive Advanced Solid Tumors
A Single-Arm, Single-Center, Open-Label Clinical Trial of Engineered T-Cell Therapy in Patients With ALPP-Positive Recurrent or Metastatic Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategic Portfolio Decision
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent or Metastatic Solid Tumors With Positive ALPP | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti ALPP CAR-T cells treatment | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anti-ALPP CAR-T Cell Therapy
- description
- Biological: Anti-ALPP CAR-T Cells Following lymphodepletion chemotherapy, participants will receive anti-ALPP CAR-T cell infusion. Drug: Fludarabine Drug: Cyclophosphamide
- interventionNames
- Biological: Anti ALPP CAR-T cells treatment
Primary outcomes (2)
- measure
- Incidence of Adverse Events of ALPP CAR-T cells [Safety and Tolerability]
- timeFrame
- Up to 24 months
- description
- The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.
- measure
- Incidence of Dose Limiting Toxicity of ALPP CAR-T cells [Safety and Tolerability]
- timeFrame
- Up to 1 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. Participants must voluntarily provide written informed consent. 2. Aged 18-70 years (inclusive). 3. Life expectancy ≥ 3 months. 4. ECOG performance status 0-1. 5. Failed or unsuitable for standard therapy. 6. At least one measurable lesion per RECIST 1.1. 7. ALPP-positive tumor confirmed by immunohistochemistry. 8. Adequate organ and bone marrow function. 9. Effective contraception required for participants of childbearing potential. 10. Adequate venous access for leukapheresis. Key Exclusion Criteria: 1. Primary CNS malignancy or uncontrolled CNS metastases. 2. Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ). 3. Active autoimmune disease or history of autoimmune disease. 4. Immunodeficiency, including HIV positivity. 5. Bleeding disorders (inherited or acquired). 6. Clinically significant cardiovascular disease. 7. Active infection (including tuberculosis, hepatitis B/C, syphilis). 8. Pregnant or breastfeeding women. 9. History of refractory epilepsy, active GI bleeding, or high risk of tumor bleeding. 10. Severe systemic or psychiatric illness. 11. Prior cell or gene therapy. 12. Severe drug hypersensitivity history. 13. Investigator-assessed unsuitability for trial participation.
References
Publications (0)
Data not yet available