NCT04152148

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	500mg BAT4306F	Phase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result
BIOLOGICAL	750mg BAT4306F	Phase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result
BIOLOGICAL	900mg BAT4306F	Phase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result
BIOLOGICAL	1000mg BAT4306F	Phase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result

Timeline

• Start date: 2018-09-04
• Primary completion: 2021-01-13
• Completion: 2021-01-13
• First posted: 2019-11-05
• Last updated: 2023-02-08

Locations

1 site across 1 country: China