NCT03332121

Brief Summary

It's the first-in-human study of Recombinant Humanized Anti-CD20 Monoclonal Antibody for Injection (B001). The main purpose of this study is to explore the safety and tolerance of B001 for patients with CD20 positive B-cell non Hodgkin's lymphoma. It will also explore the PK/PD manner and ORR in this study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2018

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

March 22, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

2.7 years

First QC Date

October 30, 2017

Last Update Submit

November 11, 2021

Conditions

CD20 Positive B Cell Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Safety of B001 as assessed by adverse reactions and events

    Incidence and intensity of adverse events according to NCI CTCAE 4.03 associated with increasing doses of B001

    42 days

Secondary Outcomes (4)

  • Concentration-time curve of B001

    112 days

  • PD results of B001

    112 days

  • Immunogenicity of B001

    112 days

  • ORR of B001

    112 days

Study Arms (1)

B001,B001 dose escalation

EXPERIMENTAL

5 groups with different dose: 350mg/700mg/1000mg/1500mg/2000mg

Biological: B001

Interventions

B001BIOLOGICAL

4 times intravenous injection totally,dosing at Day1,Day35,Day56,Day77

B001,B001 dose escalation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 18-75, male or female.
  • Patients with the following histologically-documented hematologic malignancy: CD20 positive B-cell non Hodgkin's lymphoma (NHL) or chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), according to 2016 WHO Classification of Lymphoma.
  • Patients with relapsed/refractory CD20 positive B cell NHL (including CLL/SLL )
  • Life expectancy of at least 6 months.
  • ECOG-PS score of 0-1.
  • For patients of reproductive potential, pregnancy test should be negative 7 days before treatment , and use of a reliable means of contraception during the study and 12months after discontinuing treatment. Males should be willing to use barrier contraception during the study and 12months after discontinuing treatment.
  • Provision of signed and dated ,written informed consent prior to any study specific procedures, sampling and analyses.

You may not qualify if:

  • Serious blood, renal or hepatic function impairment:
  • Absolute neutrophil count(ANC)\<1.0\*10\^9/L（Except for those with bone marrow invasion）
  • Lymphocyte Count(LYM)\>50\*10\^9/L
  • Haemoglobin(Hb)\<70g/L（Except for those with bone marrow invasion）
  • Platelet count(PLT)\<50\*10\^9/L（Except for those with bone marrow invasion）
  • Creatinine (Cr)\>1.5xULN
  • Alanine transaminase (ALT)or Aspartate aminotransferase(AST)\>2.5xULN
  • Total bilirubin (TBIL)\>2xULN
  • Patients with any anti-tumor treatment (including steroid treatment) within 4 weeks or with any chronic unresolved toxicities from prior therapy greater than Grade 2 according to NCI-CTCAE 4.03.
  • Rituximab or any other anti-CD20 monoclonal antibody treatment within 3 weeks.
  • received blood transfusion and hemopoietic stimulating factor,eg. colony-stimulating factor (CSF)、Erythropoietin(EPO) within 2 weeks.
  • Radiotherapy within 3 months.
  • Major surgery within 28 days
  • History of tumor vaccine treatment.
  • Live-virus (live attenuated) vaccine treatment within 28 days
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The second affiliated hospital of Guangzhou medical university

Guangzhou, Guangdong, China

Location

Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Tianjin, Tianjin Municipality, 300020, China

Location

Study Officials

  • Lugui Qiu, Doctor

    Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    PRINCIPAL INVESTIGATOR

  • Junyuan Qi, Doctor

    Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 6, 2017

Study Start

March 22, 2018

Primary Completion

November 30, 2020

Study Completion

February 28, 2021

Last Updated

November 15, 2021

Record last verified: 2021-11

Locations

CN(2)