Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Mantle Cell Lymphoma

Follicular Lymphoma

All Drugs and Chemicals

Antibodies

Immunoglobulins

Will be administered by intravenous infusion every 3 weeks on D1

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.

BN301

Weili Zhao, Prof.

Liling Zhang, Prof.

Jie Jin, Prof.

Zhenfang Liu, Prof.

Baijun Fang, Prof.

Zhengming Jin, Prof.

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

This is a multicenter, open-label Phase 1/2 clinical study to evaluate BN301 administered intravenously in patients with B-cell NHL who have previously failed standard therapy or who are intolerant to standard therapy. This study includes two parts: a Phase 1 dose escalation part and a Phase 2 dose expansion part. In Phase 1 and Phase 2, 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.

Laboratory tests will be performed weekly in Cycles 1-4 and every 3 weeks from Cycle 5 onwards (see Study Flow Chart). PK sample analysis will be performed on Days 1, 2, and 8 of the first two treatment cycles, Day 1 of the third treatment cycle, and at specified time points at the end of treatment (see Attachment 1). Additional clinical assessments and laboratory tests may be performed at discretion of the investigator as clinically indicated.

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

A Multicenter Phase 1/2 Clinical Study to Evaluate the Safety and Efficacy of BN301，An Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-cell Non-Hodgkin's Lymphoma

Elimination half-life (t1/2) of BN301 in plasma of each subject

Area under the plasma concentration-time curve (AUC0-t) of BN301 in plasma of each subject

The analysis of correlation between CD74 expression and BN301 efficacy

BioNova Pharmaceuticals (Shanghai) LTD.

Spots Global Cancer Trial Database for bn301

Every month we try and update this database with for bn301 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bn301

Every month we try and update this database with for bn301 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bn301 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.