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Clinical Trial NCT07487597 for Solid Tumor is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors Early Phase 1 24 Open-Label

Recruiting
Clinical Trial NCT07487597 is designed to study Treatment for Solid Tumor. It is a Early Phase 1 interventional study that is recruiting, having started on February 28, 2026, with plans to enroll 24 participants. Led by TCRCure Biopharma Ltd., it is expected to complete by February 28, 2029. The latest data from ClinicalTrials.gov was last updated on March 23, 2026.
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 (MT...Show More
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-...Show More
Official Title

A Single-Arm, Single-Center, Open-Label Pilot Study of Functionally Enhanced ALPP-Targeted Engineered T Cells for Patients With ALPP-Positive Advanced Solid Tumors

Conditions
Solid Tumor
Other Study IDs
  • ALPP-NJ003
NCT ID Number
NCT07487597
Start Date (Actual)
2026-02-28
Last Update Posted
2026-03-23
Completion Date (Estimated)
2029-02-28
Enrollment (Estimated)
24
Study Type
Interventional
PHASE
Early Phase 1
Status
Recruiting
Keywords
Advanced Solid Tumor
ALPP
CAR-T
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalEnhanced ALPP CAR-T
Following lymphodepletion chemotherapy, participants will receive enhanced ALPP CAR-T cell infusion.
Enhanced ALPP CAR-T treatment
Enhanced ALPP CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Safety of Enhanced ALPP CAR-T cells
The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.
Up to 24 months
Safety of Enhanced ALPP CAR-T cells
Incidence of DLT
Up to 1 month
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Efficacy of Enhanced ALPP CAR-T cells
Optimal objective response rate (ORR)
Up to 24 months
To investigate the Cmax of Enhanced ALPP CAR-T cells in the peripheral blood after infusion
To detect ALPP CAR copies in peripheral blood, then calculated Cmax.
Up to 24 months
To assess Enhanced ALPP CAR-T cell trafficking into tumor tissues after infusion
To detect ALPP CAR-T cell number in tumor tissues after infusion
Up to 24 months
To investigate the AUC of Enhanced ALPP CAR-T cells in the peripheral blood after infusion
To detect ALPP CAR copies in peripheral blood, then calculated AUC.
Up to 24 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  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.
TCRCure Biopharma Ltd. logoTCRCure Biopharma Ltd.
Study Central Contact
Contact: Tangfeng LV, MD, 02580863234, [email protected]
1 Study Locations in 1 Countries

Jiangsu

The Jinling Hospital, Nanjing, Jiangsu, China
Tangfeng Lv, MD, Contact, 02580863234, [email protected]
Recruiting