Status:
RECRUITING
GSL Synthetase Inhibitor Eliglustat Combined With CD30 Target Immunotherapy for the Treatment of of CD30+ Lymphoma
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 modif...
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 response...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
December 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2029
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07138547
Start Date
December 26 2025
End Date
August 31 2029
Last Update
January 2 2026
Active Locations (1)
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1
People's Liberation Army General Hospital
Beijing, Beijing Municipality, China, 100853