Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTCRCure Biopharma Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
Participants must voluntarily provide written informed consent.
Aged 18-70 years (inclusive).
Life expectancy ≥ 3 months.
ECOG performance status 0-1.
Disqualifiers
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.
Immunodeficiency, including HIV positivity.
Trial design
Treatments tested in this trial
- Enhanced ALPP CAR-T treatment
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov