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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Enhanced ALPP CAR-T treatment
Biological/VaccineEnhanced ALPP CAR-T cells Treatment follows a lymphodepletion Drug: Fludarabine and Cyclophosphamide.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Enhanced ALPP CAR-TExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of Enhanced ALPP CAR-T cells
The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings.
Time frame
Up to 24 months2
Safety of Enhanced ALPP CAR-T cells
Incidence of DLT
Time frame
Up to 1 monthSecondary outcomes
1
Efficacy of Enhanced ALPP CAR-T cells
Optimal objective response rate (ORR)
Time frame
Up to 24 months2
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.
Time frame
Up to 24 months3
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
Time frame
Up to 24 months4
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.
Time frame
Up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov