Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Alemtuzumab

Antineoplastic Agents, Immunological

Immunoglobulins, Intravenous

Immunologic Factors

safety and tolerability, pharmacokinetic characteristics and preliminary efficacy 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 of recombinant humanized anti-cd52 monoclonal antibody injection

Single dosing: DLT observation for 7 days after administration; Multiple dosing: 3times/weeks,12 times, 28 days of DLT observation

Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection

yu xiaoge

xiaoge yu

jianyong Li

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

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

Phase Ⅰ Clinical Study of Anti-CD52 Monoclonal Antibody in NHL and T-PLL

Recombinant Humanized Anti-CD52 Monoclonal Antibody in the Treatment of Relapsed and Refractory NHL and Initially Treated T-PLL Phase I Clinical Study on Safety and Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy

Adverse events that occurred during the entire study period were evaluated and graded according to NCI-CTCAE v5.0, and dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) were observed.

Safety evaluation indexes include vital signs, physical examination, 12-lead electrocardiogram, echocardiography, clinical laboratory examination indexes (blood routine, blood biochemistry, urine routine, coagulation function, etc.), changes of ECOG physical fitness score, adverse events and serious adverse event, etc.

Area under the plasma concentration versus time curve(AUC 0-∞)

Area under the plasma concentration versus time curve(AUC 0-t）

Steady State Maximum Concentration(Cmax,ss)

Steady State Minimal Concentration(Cmin,ss)

Steady State Area under the plasma concentration versus time curve(AUC 0-t),ss

ORR (including CR and PR), disease control rate (DCR), remission duration (DOR) and progression-free survival (PFS) in objective remission rate

drug-resistant antibody (ADA) and neutralizing antibody (NAb)

Spots Global Cancer Trial Database for Phase Ⅰ Clinical Study of Anti-CD52 Monoclonal Antibody in NHL and T-PLL

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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