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

NCT04152148 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-02-08

No results posted yet for this study

Summary

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

Conditions

  • Non-Hodgkin's Lymphoma

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Yuqin Song, investigator · Peking University Cancer Hospital & Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-04
Primary Completion
2021-01-13
Completion
2021-01-13

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04152148 on ClinicalTrials.gov