Solid Tumor
Conditions
Keywords
Advanced Solid Tumor, ALPP, CAR-T
Brief summary
This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of functionally enhanced ALPP-targeted engineered T Cells (Herein referred to as Enhanced ALPP CAR-T) 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.
Detailed description
This study is designed as a single-arm, open-label, single-dose clinical trial to evaluate the safety and efficacy of Enhanced ALPP CAR-T in patients with recurrent or metastatic solid tumors. The study protocol consists of five main stages: (1) patient screening, (2) collection of peripheral blood mononuclear cells (PBMCs), (3) lymphodepletion chemotherapy, (4) ALPP CAR-T cell infusion, and (5) post-infusion follow-up.
Interventions
BIOLOGICALEnhanced ALPP CAR-T treatment
Enhanced ALPP CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.
Sponsors
TCRCure Biopharma Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Enhanced ALPP CAR-T cells | Up to 24 months | The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Enhanced ALPP CAR-T cells | Up to 24 months | Optimal objective response rate (ORR) |
| To investigate the Cmax of Enhanced ALPP CAR-T cells in the peripheral blood after infusion | Up to 24 months | To detect ALPP CAR copies in peripheral blood, then calculated Cmax. |
| To assess Enhanced ALPP CAR-T cell trafficking into tumor tissues after infusion | Up to 24 months | To detect ALPP CAR-T cell number in tumor tissues after infusion |
| To investigate the AUC of Enhanced ALPP CAR-T cells in the peripheral blood after infusion | Up to 24 months | To detect ALPP CAR copies in peripheral blood, then calculated AUC. |
Countries
China
Contacts
CONTACTTangfeng LV, MD
PRINCIPAL_INVESTIGATORTangfeng Lv, MD
The Jinling Hospital
Outcome results
None listed