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Study of BN301, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies

NCT05611853 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-02-21

No results posted yet for this study

Summary

Phase 1/2 trial to study the safety, pharmacokinetics and preliminary efficacy of BN301 given intravenously every 3 weeks.

Conditions

Interventions

DRUG

BN301

BN301 will be administered intravenously on Day 1 of every 21-day cycle until disease progression, intolerable toxicity, withdrawal of consent, loss to follow-up, death, or other conditions in which patients are not suitable for study treatment, whichever occurs first. Since this is the first time BN301 will be used in Chinese patients, it is planned to enroll 1 subject at the first dose level of 3.5 mg/kg.

Sponsors & Collaborators

  • BioNova Pharmaceuticals (Shanghai) LTD.

    lead INDUSTRY

Principal Investigators

  • Weili Zhao, Prof. · Shanghai Jiaotong University school of Medicine, Ruijin Hospital

  • Liling Zhang, Prof. · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  • Jie Jin, Prof. · The first affiliated hospital, Zhejiang Unviersity school of medicine

  • Zhenfang Liu, Prof. · The First Affiliated School of Guangxi Medical University

  • Baijun Fang, Prof. · Henan Oncology Hospital

  • Zhengming Jin, Prof. · The First Affiliated Hospital of Soochow University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-25
Primary Completion
2023-12-25
Completion
2023-12-25

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05611853 on ClinicalTrials.gov