GSL Synthetase Inhibitor Eliglustat Combined With CD30 Target Immunotherapy for the Treatment of of CD30+ Lymphoma

Sponsor
Chinese PLA General Hospital
Study ID
NCT07138547
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Eliglustat, CD30 target immunotherapy — DRUG
    Eliglustat 63mg will be administered twice daily in the first 14 days and the following every other week. CD30 target immunotherapy：Brentuximab Vedotin or CD30-targeting CAR-T Cell Therapy.

Study Details

Targeted therapy against the CD30 molecule has achieved some progress in CD30-positive Hodgkin lymphoma, but its efficacy remains unsatisfactory. Previous studies have demonstrated that N-glycan modifications in the extracellular domain of target proteins can disrupt immune synapse formation with CAR-T cells. Our preliminary research has shown that ablation of N-glycans on CD30 enhances the anti-tumor effect of CD30-targeted therapy.It is hypothesized that Eliglustat, by inhibiting GSL synthesis,may potentiate the anti-tumor effect. Consequently,we designed and initiated a single-center, open-label phase I/II clinical study to evaluate the efficacy and feasibility of Eliglustat combined with CD30 targeted immunotherapy in patients with CD30-positive lymphoma. The primary endpoint of this study is the safety and efficacy of Eliglustat combined with CD30 targeted therapies.

Key Dates

First listed
Aug 24, 2025
Start date
Dec 26, 2025
Status verified
Dec 2025
Primary completion
Aug 31, 2028
Completion
Aug 31, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with CD30+ lymphoma
    Eliglustat 63mg will be administered twice daily in patients who are CYP2D6 extensive metabolizers (EMs), or intermediate metabolizers (IMs), in the first 14 days and the following every other week until 24 weeks. For patients who still benefit from the trial, eliglustat 63mg will be administered twice daily every other week to 96 weeks. CD30 target immunotherapy: Brentuximab Vedotin 1.2-1.8mg/kg day 1 Q21d; or CD30-targeting CAR-T Cell Therapy( Application should be in accordance with the specific instructions for each cell preparation).

Primary Outcome Measure

Number of Subjects with treatment-related adverse events (AEs) [ Time Frame: Up to 120 days after the last dose of study drugs] ]

Central Contacts

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