Cord Blood-derived CAR-NK Cells Targeting CD19 for Refractory/Relapsed Central Nervous System Lym… (NCT06827782) | Clinical Trial Compass
By InvitationPhase 1
Cord Blood-derived CAR-NK Cells Targeting CD19 for Refractory/Relapsed Central Nervous System Lymphoma
China42 participantsStarted 2025-03-01
Plain-language summary
This study is designed to evaluate the safety and efficacy of cord blood-derived CAR-NK019 in the treatment of refractory/relapsed central nervous system lymphoma.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Voluntarily participate in the study and sign the informed consent;
✓. Age 18-75 years old, male or female;
✓. Diffuse large B-cell lymphoma (DLBCL) was confirmed by histology. CD19 expression was positive by lymphoma pathology or flow cytometry, and CD19 expression was ≥20% by IHC.
✓. Imaging showed no evidence of systemic lymphoma;
✓. Meets any of the following definitions for refractory/relapsed CNS lymphoma: no complete response has been achieved with prior 2-line regimen including methotrexate or cytarabine-based regimen; Disease progression during any treatment; The stable time of disease after effective treatment is less than 6 months; Disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation.
✓. Imaging showed the presence of at least one measurable lesion, with a minimum diameter of ≥10mm;
✓. Expected survival ≥3 months;
✓. ECOG score 0-3 points;
Exclusion criteria
✕. Allergic to any of the components of cell products;
✕. History of other tumors;
✕. Acute grade II-IV (Glucksberg standard) GvHD or generalized chronic GvHD occurred after previous allogeneic hematopoietic stem cell transplantation; Or are receiving anti-GVHD treatment;
What they're measuring
1
Incidence of dose limiting toxicity (DLTs)
Timeframe: Up to 28 days
Trial details
NCT IDNCT06827782
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
. Have received gene therapy within the past 3 months;
✕. Active infections requiring treatment (except simple urinary tract infections, bacterial pharyngitis), but prophylactic antibiotic, antiviral and antifungal infection treatment is permitted;
✕. Persons infected with hepatitis B (HBsAg positive, but HBV-DNA\<103 is not excluded) or hepatitis C virus (including virus carriers), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to HIV-infected persons;
✕. Subjects with Grade III or IV cardiac dysfunction according to the New York Heart Association's cardiac function grading criteria;
✕. Patients who received antitumor therapy in the early stage but did not recover toxicity (CTCAE 5.0 toxicity did not recover to ≤ grade 1, except fatigue, anorexia, alopecia);