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A Phase I Clinical Trial of BAT4306F on Safety, Tolerability and Pharmacokinetics for Patients

Non-Hodgkin's Lymphoma Clinical Trial

Official title:
A Phase I Clinical Trial of BAT4306F (for Injection) on Safety, Tolerability and Pharmacokinetics for Patients With CD20-positive, B-cell Non-Hodgkin's Lymphoma

Clinical Trial Summary

The primary objective of the study is to evaluate the safety and tolerability of BAT4306F in patients with CD20-positive B-cell lymphoma

Clinical Trial Description

1. The primary objective of the study is to evaluate the safety and tolerability of BAT4306F in patients with CD20-positive B-cell lymphoma, when the injection dosage escalates, to ultimately determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and recommended dosage for phase II clinical studies ( RP2D); 2. To evaluate the pharmacokinetics (PK) of BAT4306F(for injection); 3. To evaluate the immunogenicity profile of BAT4306F(for injection); 4. To evaluate the efficacy profile of BAT4306F (for injection);Using the Lugano criteria (2014), the 2008 IWCLL efficacy evaluation criteria, and the 2014 IWWM-7 efficacy evaluation criteria were used to evaluate the efficacy of related diseases at week 7, week 13, and week 19. The index of evaluation was ORR (including CR, PR, SD and PD, ORR is the proportion of patients with CR and PR). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04152148
Study type Interventional
Source Bio-Thera Solutions
Contact
Status Completed
Phase Phase 1
Start date September 4, 2018
Completion date January 13, 2021
View Details
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