NCT05557903

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: Lanzhou Institute of Biological Products Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Lymphoma, Non-Hodgkin
• Lymphoma, T-Cell

Interventions

Type	Name	Description
BIOLOGICAL	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

Timeline

• Start date: 2021-12-20
• Primary completion: 2022-12-30
• Completion: 2023-06-30
• First posted: 2022-09-28
• Last updated: 2022-09-28

Locations

1 site across 1 country: China