B001 in Patients With CD20 Positive B-cell Non Hodgkin's Lymphoma

November 11, 2021 updated by: Shanghai Pharmaceuticals Holding Co., Ltd

Phase Ia Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Recombinant Humanized Anti-CD20 Monoclonal Antibody for Injection(B001)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Phase I dose escalation study

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • The Second Affiliated Hospital of Guangzhou Medical University
    • Tianjin
      • Tianjin, Tianjin, China, 300020
        • institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age of 18-75, male or female.
  2. 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.
  3. Patients with relapsed/refractory CD20 positive B cell NHL (including CLL/SLL )
  4. Life expectancy of at least 6 months.
  5. ECOG-PS score of 0-1.
  6. 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.
  7. Provision of signed and dated ,written informed consent prior to any study specific procedures, sampling and analyses.

Exclusion Criteria:

  1. 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
  2. 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.
  3. Rituximab or any other anti-CD20 monoclonal antibody treatment within 3 weeks.
  4. received blood transfusion and hemopoietic stimulating factor,eg. colony-stimulating factor (CSF)、Erythropoietin(EPO) within 2 weeks.
  5. Radiotherapy within 3 months.
  6. Major surgery within 28 days
  7. History of tumor vaccine treatment.
  8. Live-virus (live attenuated) vaccine treatment within 28 days
  9. High dose of steroid treatment (hydroprednisone >10mg/day or relevant dose of other drugs)
  10. Patients with history of hematopoietic stem cell transplantation or planning to receive hematopoietic stem cell transplantation within 3 months.
  11. Patients with history of Gastrointestinal perforation and/or fistula within 6 months.
  12. Lymphoma in CNS, ADIS related lymphoma
  13. Active infection by bacteria,virus,fungus which required hospitalization or severe infection required intravenous administration of antibiotics

  14. Concomitant severe disease including but not limited to:

    • Known HIV or ADIS related disease
    • Asthma or interstitial lung disease or severe COPD
    • Myocardial infarction, unstable angina, Cardiovascular interventional surgery, Congestive heart failure(CHF; NYHA Grade II-IV), symptomatic or poorly controlled arrhythmia within 6 months before enrolling
    • The systolic pressure ≥140mmHg,or diastolic pressure≥90mmHg post treatment.
    • Acute or chronic hypotension(<90/60mmHg)
    • History of toxic epidermal necrolysis or Stevens-Johnson syndrome
    • Rheumatoid arthritis Granulomatous angiitis or microscopic polyangiitis
    • Ileus or history of following disease: inflammatory bowel disease or extensive intestinal resection(extensive bowel resection or hemicolectomy, combining chronic diarrhea), Crohn's disease, ulcerative colitis or chronic diarrhea.
    • Previous or concomitant malignant, except basal-cell carcinoma or squamous cell carcinoma and/or cervical carcinoma in situ or effectively treated hematological malignancy and solid tumor that has been remission for more than 3 years and is considered to be cured.
    • Any history may affect the study result: increasing dosing risk or affect lab values and Judgment by the investigator that the patient should not participate in the study,
  15. HBsAg positive; HBcAb positive and HBV-DNA≥upper limit of detection, HCV positive; HIV positive
  16. Allergy to humanized antibody or human-mouse chimeric antibody.
  17. Woman who are breast feeding or pregnant
  18. Judgment by the investigator that the patient should not participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: B001,B001 dose escalation
5 groups with different dose: 350mg/700mg/1000mg/1500mg/2000mg
Biological: B001
4 times intravenous injection totally,dosing at Day1,Day35,Day56,Day77

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety of B001 as assessed by adverse reactions and events
Time Frame: 42 days
Incidence and intensity of adverse events according to NCI CTCAE 4.03 associated with increasing doses of B001
42 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Concentration-time curve of B001
Time Frame: 112 days
Measure the concentration of B001 in serum at different time point to get a concentration-time curve.
112 days
PD results of B001
Time Frame: 112 days
Measure the number of CD19 positive B cell in peripheral blood
112 days
Immunogenicity of B001
Time Frame: 112 days
Content analysis of anti-B001 antibody
112 days
ORR of B001
Time Frame: 112 days
Objective response rate according to Response Criteria for Lymphoma（not including PET）and CLL Response Criteria
112 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Pharmaceuticals Holding Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B001-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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