LymphomaPhase 1/2NCT07138547
GSL Synthetase Inhibitor Eliglustat Combined With CD30 Target Immunotherapy for the Treatment of of CD30+ Lymphoma
A Phase 1/2 study testing Eliglustat, CD30 target immunotherapy in people with Lymphoma, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- Eliglustat, CD30 target immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2025to 31 Aug 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 years of age.
- ECOG performance of less than 2.
- Subjects must have histological confirmation CD30+ lymphoma.
- Patients must have at least one line of antitumor therapy
- Life expectancy of at least 3 months.
- Subjects with lymphoma must have at least one measureable lesion >1cm as defined by lymphoma response criteria.
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- Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study, and subjects have recovered to ≤ grade 1 toxicity.
- Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
- Subjects must have adequate marrow, live, renal and heart functions.
Who cannot join
- Participants with CD30- lymphoma.
- CYP2D6 ultra-rapid metabolizers (URMs).
- The patients is taking a CYP2D6 inhibitor and/or concomitantly with a strong or moderate CYP3A inhibitor.
- Subjects with a history of severe hypersensitivity reactions to CD30 target immunotherapy.
- History of allergy or intolerance to study drug components.
- Known brain metastases or active central nervous system (CNS). Subjects with CNS metastases who were treated with radiotherapy for at least 3 months prior to enrollment, have no central nervous symptoms and are off corticosteroids, are eligible for enrollment, but require a brain MRI screening.
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- Uncontrolled intercurrent illness, including ongoing or active systemic infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (excluding insignificant sinus bradycardia and sinus tachycardia) or psychiatric illness/social situations and any other illness that would limit compliance with study requirements and jeopardize the safety of the patient.
- Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
- Previous or concurrent cancer within 3 years prior to treatment start except for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
- Major surgery or trauma occurred within 28 days prior to enrollment, or major side effects have not been recovered.
- Vaccination within 30 days of study enrollment.
- Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month.
- Pregnant or breast-feeding. Women of childbearing potential must have a pregnancy test performed within 7 days before the enrollment, and a negative result must be documented
- Being participating any other trials or withdraw within 4 weeks.
- Unable to swallow and retain oral medication, malabsorption syndrome, conditions that significantly impair gastrointestinal function, total gastrectomy or small bowel resection, ulcerative colitis, symptomatic inflammatory bowel disease, partial or complete intestinal obstruction.
- Researchers believe that other reasons are not suitable for clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100853
weidong han, 01055499341, hanwdrsw@sina.com
About this study
Official title: GSL Synthetase Inhibitor Eliglustat Combined With CD30 Target Immunotherapy for the Treatment of of CD30+ Lymphoma: an Open-Label, Randomized, Phase I/II Study
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.
Read the detailed description
CD30-targeted therapies, including Brentuximab Vedotin (BV) and CD30-targeted CAR-T cells, have demonstrated limited efficacy in Hodgkin lymphoma,facing challenges such as the lack of durable responses with BV and low complete response (CR) rates with CD30 CAR-T cells. Existing research indicates that N-glycan modifications in the extracellular domain of target proteins may mediate resistance of tumor cells to CAR-T cell therapy.Our preliminary studies have demonstrated that disrupting the CD30 N-glycans in HL tumor cells enhances the anti-tumor effect of CD30-targeted therapy. Based on this, we hypothesize that the glucosylceramide synthase (GSL synthesis) inhibitor Eliglustat, by inhibiting GSL synthesis, may affect N-glycan structure of target proteins and consequently enhancing anti-tumor efficacy.
To further validate the role of Eliglustat in modulating anti-tumor therapy for CD30-positive lymphoma, we designed and initiated a single-center, open label phase I/II clinical study. This study aims to evaluate the efficacy and feasibility of Eliglustat combined with CD30 immunotherapy in patients with CD30-positive lymphoma.Primary Endpoints:1）safety and of Eliglustat combined with CD30 targeted therapies；2）CR rate (%) in the CAR-T cell plus Eliglustat treatment group; Progression-free survival (PFS) in the BV plus Eliglustat treatment group.Secondary Endpoints: 1)Other efficacy indicators (e.g., Objective Response Rate [ORR]) of Eliglustat combined with CD30- targeted molecular therapy; 2) Efficacy biomarkers.
- Conditions
- Lymphoma
- Being tested
- Eliglustat, CD30 target immunotherapy
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eliglustat, CD30 target immunotherapyDrug
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 group | Role | What they receive |
|---|---|---|
| Patients with CD30+ lymphoma | Experimental | 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). Receives: Drug: Eliglustat, CD30 target immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects with treatment-related adverse events (AEs)
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Measured: Up to 120 days after the last dose of study drugs]
CR rate (CRR) in the CAR-T cell plus Eliglustat treatment group
The Complete Response Rate (CRR), as assessed by the investigator, is the proportion of all evaluable subjects who achieve a complete response.
Measured: 12 months
Progression-free survival (PFS) in the BV plus Eliglustat treatment group.
Time from the date of first administration of the study drug to disease progression or death from any cause (any earliest date).
Measured: 2 years
Secondary outcomes (2)
Objective Response Rate [ORR]
The percentage of patients with CR or PR was determined according to the revised lymphoma efficacy evaluation criteria.
Measured: 12 months
CR rate (CRR) /Progression-free survival (PFS)based on CD30 expression level in tumor tissue.
CD30 expression will be evaluated by immunohistochemistry (IHC), and its expression levels will be analyzed for association with CRR/PFS.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start26 Dec 2025 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138547
- Sponsor's protocol ID
- CHN-PLAGH-BT-097
- Status last verified
- Dec 2025
- First submitted
- 14 Aug 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GSL Synthetase Inhibitor Eliglustat Combined With CD30 Target Immunotherapy for the Treatment of of CD30+ Lymphoma: an Open-Label, Randomized, Phase I/II Study
- ClinicalTrials.gov ID
- NCT07138547
- Acronym / sponsor ID
- CHN-PLAGH-BT-097
- Conditions
- Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 26 Dec 2025 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
CD30-targeted therapies, including Brentuximab Vedotin (BV) and CD30-targeted CAR-T cells, have demonstrated limited efficacy in Hodgkin lymphoma,facing challenges such as the lack of durable responses with BV and low complete response (CR) rates with CD30 CAR-T cells. Existing research indicates that N-glycan modifications in the extracellular domain of target proteins may mediate resistance of tumor cells to CAR-T cell therapy.Our preliminary studies have demonstrated that disrupting the CD30 N-glycans in HL tumor cells enhances the anti-tumor effect of CD30-targeted therapy. Based on this, we hypothesize that the glucosylceramide synthase (GSL synthesis) inhibitor Eliglustat, by inhibiting GSL synthesis, may affect N-glycan structure of target proteins and consequently enhancing anti-tumor efficacy.
To further validate the role of Eliglustat in modulating anti-tumor therapy for CD30-positive lymphoma, we designed and initiated a single-center, open label phase I/II clinical study. This study aims to evaluate the efficacy and feasibility of Eliglustat combined with CD30 immunotherapy in patients with CD30-positive lymphoma.Primary Endpoints:1）safety and of Eliglustat combined with CD30 targeted therapies；2）CR rate (%) in the CAR-T cell plus Eliglustat treatment group; Progression-free survival (PFS) in the BV plus Eliglustat treatment group.Secondary Endpoints: 1)Other efficacy indicators (e.g., Objective Response Rate [ORR]) of Eliglustat combined with CD30- targeted molecular therapy; 2) Efficacy biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with CD30+ lymphoma | Experimental | Drug: Eliglustat, CD30 target immunotherapyEliglustat 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 to 75 years of age.
- ECOG performance of less than 2.
- Subjects must have histological confirmation CD30+ lymphoma.
- Patients must have at least one line of antitumor therapy
- Life expectancy of at least 3 months.
Key exclusion criteria (16 listed)
- Participants with CD30- lymphoma.
- CYP2D6 ultra-rapid metabolizers (URMs).
- The patients is taking a CYP2D6 inhibitor and/or concomitantly with a strong or moderate CYP3A inhibitor.
- Subjects with a history of severe hypersensitivity reactions to CD30 target immunotherapy.
- History of allergy or intolerance to study drug components.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eliglustat, CD30 target immunotherapyEliglustat 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. | Drug | Patients with CD30+ lymphoma |
Primary outcome
Number of Subjects with treatment-related adverse events (AEs)
Time frame: Up to 120 days after the last dose of study drugs]
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
CR rate (CRR) in the CAR-T cell plus Eliglustat treatment group
Time frame: 12 months
The Complete Response Rate (CRR), as assessed by the investigator, is the proportion of all evaluable subjects who achieve a complete response.
Progression-free survival (PFS) in the BV plus Eliglustat treatment group.
Time frame: 2 years
Time from the date of first administration of the study drug to disease progression or death from any cause (any earliest date).
2 secondary outcomes
Objective Response Rate [ORR]
Time frame: 12 months
CR rate (CRR) /Progression-free survival (PFS)based on CD30 expression level in tumor tissue.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Eliglustat, CD30 target immunotherapy in people with Lymphoma, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Han wei dong (+861055499341, hanwdrsw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.