Actively Recruiting
GSL Synthetase Inhibitor Eliglustat Combined With CD30 Target Immunotherapy for the Treatment of of CD30+ Lymphoma
Led by Chinese PLA General Hospital · Updated on 2026-01-02
40
Participants Needed
1
Research Sites
192 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GSL Synthetase Inhibitor Eliglustat Combined With CD30 Target Immunotherapy for the Treatment of of CD30+ Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- ECOG performance status less than 2
- Histologically confirmed CD30-positive lymphoma
- At least one prior line of antitumor therapy
- Life expectancy of at least 3 months
- At least one measurable lymphoma lesion larger than 1 cm
- Previous treatments completed more than 4 weeks before enrollment with recovery to grade 1 toxicity or less
- Autologous hematopoietic stem-cell transplantation completed more than 3 months prior
- Adequate bone marrow, liver, kidney, and heart function
You will not qualify if you...
- Diagnosis of CD30-negative lymphoma
- Being a CYP2D6 ultra-rapid metabolizer
- Taking CYP2D6 inhibitors or strong/moderate CYP3A inhibitors
- History of severe hypersensitivity to CD30-targeted immunotherapy
- Allergy or intolerance to study drug components
- Known brain metastases or active central nervous system disease (unless treated and stable with no symptoms and off corticosteroids)
- Uncontrolled illnesses such as active infections, serious heart conditions, psychiatric illness, or other health issues limiting study participation
- Positive HIV/AIDS test
- Other cancers within 3 years except certain treated non-invasive cancers
- Major surgery or trauma within 28 days before enrollment
- Vaccination within 30 days before enrollment
- Active or recent alimentary tract bleeding
- Pregnant or breastfeeding women
- Participation in other clinical trials within 4 weeks
- Inability to swallow or retain oral medication or significant gastrointestinal disorders
- Any other reasons deemed unsuitable by researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
People's Liberation Army General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
H
Han wei dong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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