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Phase I clinical study of multicenter, single-arm, open, non-randomized evaluation of recombinant humanized anti-CD52 monoclonal antibody in the NHL and T-PLL
Full description
Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection in the Treatment of Relapsed and Refractory NHL (Including CLL/SLL, PLL, PTCL, Diffuse Large B-cell Lymphoma, Follicular Cell Lymphoma, Mantle Cell Lymphoma, and Marginal Zone Lymphoma) and Initially Treated T-PLL Phase I Clinical Study on Safety and Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy
Enrollment
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Inclusion criteria
For Patients With Relapsed And Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma/Lymphoblastic Leukemia (CLL/SLL/PLL) And Initial Treated t-Lymphoblastic Leukemia ( InitialTreated T-PLL)
-Patients with CLL/SLL or PLL were confirmed by histopathological or flow immunotyping;
Patients with indications for treatment according to iwCLL2018 criteria and determined by the investigator;
Age from 18 to 70 (including boundary value), no gender limitation;
ECOG physical condition score 0 ~ 2;
Patients have measurable lesions (lymphadenopathy (maximum baseline diameter ≥1.5 cm), or hepatomegaly/splenomegaly due to CLL or PLL or peripheral tumor lymphocytes >5×10E9/L);
CLL/SLL patients are intolerant or resistant to previous BTK inhibitor treatment; Or newly treated patients with T-PLL; Or relapse-resistant PLL (relapse-resistant PLL is defined as disease progression following recent remission of treatment. Treatment-resistant disease was defined as failure to achieve ≥PR from the most recent treatment or disease progression within 6 months of the last treatment);
Laboratory test results must meet the following requirements (no blood components, short-acting cell growth factor and other drugs are allowed within 7 days prior to laboratory test; Long-acting growth factor is not allowed within the first 14 days), and laboratory test results within 7 days before screening;
Life expectancy > 3 months;
Fertile men and women of reproductive age are willing to take effective contraceptive measures from the signing of informed consent to 6 months after the last administration of the experimental drug; Women of childbearing age must have a negative blood pregnancy test no later than 7 days before the first trial drug is administered.
Agreed to follow the experimental treatment plan and visit plan, voluntarily enrolled in the study, and signed written informed consent.
For Other Relapsed And Refractory Non-Hodgkin's Lymphoma
Non-hodgkin's lymphoma was confirmed by histopathology according to world Health Organization (WHO) classification of disease, and did not respond to standard treatment;
ECOG physical condition score 0~2;
Age from 18 to 70 (including boundary value), no gender limitation;
Life expectancy > 3 months;
At least one measurable lesion with a maximum diameter ≥1.5cm is present;
Laboratory test results must meet the following requirements (no blood components, short acting cell growth factor, albumin and other drugs are allowed to be given within 7 days before obtaining laboratory test; Long acting growth factor is not allowed in the first 14 days) :
Agreed to follow the experimental treatment plan and visit plan, voluntarily enrolled in the study, and signed written informed consent.
Exclusion criteria
For Patients With Relapsed And Refractory CLL/SLL/PLL And Initial Treated T-PLL
For Other Relapsed And Refractory Non-Hodgkin's Lymphoma
Primary purpose
Allocation
Interventional model
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71 participants in 1 patient group
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Central trial contact
yu xiaoge
Data sourced from clinicaltrials.gov
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