CD70-CAR-NK Cell Therapy for T Cell Lymphoma and Acute Myeloid Leukemia (NCT06696846) | Clinical Trial Compass
RecruitingPhase 1
CD70-CAR-NK Cell Therapy for T Cell Lymphoma and Acute Myeloid Leukemia
China25 participantsStarted 2024-12-01
Plain-language summary
CD70 is a promising target for immunotherapy because it is overexpressed in T-cell lymphoma (TCL) and acute myeloid leukemia (AML) tumor cells but is found in deficient levels in normal tissues and hematopoietic stem cells. This study aims to evaluate the safety and efficacy of CD70-targeted CAR-NK (CD70-CAR-NK) cells in patients with relapsed and refractory TCL and AML.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Voluntarily participate in this study and sign the informed consent form;
✓. Aged between 18-75 years old, both male and female are eligible;
✓. Relapsed/refractory T cell lymphoma is defined as: relapsed/refractory after having received at least two or more lines of previous treatment (patients with anaplastic large -cell lymphoma must have been exposed and resistant to Brentuximab vedotin). The celluar subtypes of T-cell lymphoma include: angioimmunoblastic T-cell lymphoma; peripheral T - cell lymphoma not otherwise specified; ALK-negative anaplastic large - cell lymphoma; Relapsed/refractory AML is defined as: leukemia cells reappear in the peripheral blood after complete remission or the blasts in the bone marrow ≥ 5% or the extramedullary leukemia infiltration outside. Or newly diagnosed cases did not achieve a CR after two courses of standard regimens; those who relapse within 12 months after CR after consolidation and intensification treatment; those who relapse after 12 months and have not responded to conventional chemotherapy; those who relapse two or more times; those with persistent extramedullary leukemia;
✓. The expected survival period ≥ 12 weeks;
✓. CD70 expression is positive in tumor tissue puncture sections/tumor cells detected by flow cytometry, and the number of CD70 - positive cells detected by immunohistochemistry ≥ 20% (++ or more);
✓. ECOG score is 0 - 2;
✓. Adequate organ function reserve:
✓. Previous autologous hematopoietic stem cell transplantation is allowed once;
Exclusion criteria
✕
What they're measuring
1
The incidence and type of dose-limiting toxicity (DLT) within 28 days
Timeframe: 28 days
2
the incidence and severity of treatment-related adverse events as assessed by CTCAE v4.0
Timeframe: within 90 days after CAR-NK infusion
Trial details
NCT IDNCT06696846
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
. Those with a history of allergy to any component in the cellular product;
✕. Those with a history of other tumors;
✕. Those who had grade II - IV (Glucksberg criteria) acute GvHD or extensive chronic GvHD after previous allogeneic hematopoietic stem cell transplantation; or those who are currently receiving anti - GvHD treatment;
✕. Those who have received gene therapy within the past 3 months;
✕. Those with active infections requiring treatment (except for simple urinary tract infections and bacterial pharyngitis). However, prophylactic antibiotic, antiviral, and antifungal treatments are permitted;
✕. Subjects with hepatitis B (HBsAg - positive, but HBV - DNA \< 103 is not an exclusion criterion) or hepatitis C virus infection (including virus carriers), syphilis, and other acquired or congenital immunodeficiency diseases, including but not limited to those infected with the AIDS virus;
✕. Subjects with grade III or IV cardiac insufficiency according to the New York Heart Association cardiac function classification standard of the United States;
✕. Those whose toxic reactions from previous anti - tumor treatment have not recovered (CTCAE 5.0 toxic reactions have not recovered to ≤ grade 1, except for fatigue, anorexia, and alopecia);