Clinical Study on the Safety and Efficacy of CD20/CD19 Cell Injection in the Treatment of Relapse… (NCT07345741) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Study on the Safety and Efficacy of CD20/CD19 Cell Injection in the Treatment of Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
China28 participantsStarted 2025-12-31
Plain-language summary
Evaluate the safety and tolerability of AcNK-Sup003 cell injection in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). To preliminarily determine the Maximum Tolerated Dose (MTD) or recommended clinical dose of AcNK-Sup003 cell injection.
Who can participate
Age range18 Years – 78 Years
SexALL
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Inclusion Criteria:
Written informed consent: Signed written informed consent and ability to comply with protocol-specified visits and procedures.
Age and life expectancy: Age ≥ 18 years with an expected survival of more than 3 months.
Pathological diagnosis: Histopathologically confirmed CD20+ relapsed or refractory B-cell non-Hodgkin lymphoma (according to WHO 2016 lymphoma classification), including but not limited to:
Diffuse large B-cell lymphoma (DLBCL) High-grade B-cell lymphoma (HGBCL) Follicular lymphoma grade 3b (3b FL)
Relapsed or refractory disease: Defined by meeting one or more of the following:
Relapse, non-response, or progression after hematopoietic stem cell transplantation Stable disease for ≤ 6 months after at least two cycles of second-line therapy (DLBCL/HGBCL/3b FL subtypes must have received CD20-targeted agents and anthracyclines; other subtypes evaluated by investigator for treatment adequacy) Disease progression or relapse after at least second-line therapy (DLBCL/HGBCL/3b FL subtypes must have received CD20-targeted agents and anthracyclines; other subtypes evaluated by investigator for treatment adequacy) ECOG performance status: 0-2.
Contraception requirements:
Fertile males and females of childbearing potential must agree to use effective contraception from signing informed consent until 6 months after last study drug administration Negative serum pregnancy test required for females of childbearing potential at screening
Measurable dise…
What they're measuring
1
Overall survival
Timeframe: Time frame:1, 3,6,12,18, 24 months after treatment