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

Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT03332121
Collaborator
(none)
30
Enrollment
2
Locations
1
Arm
35.3
Actual Duration (Months)
15
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: B001
 Phase 1

Detailed Description

Phase I dose escalation study

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase Ia Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Pharmacodynamics of Recombinant Humanized Anti-CD20 Monoclonal Antibody for Injection(B001)
Actual Study Start Date :
Mar 22, 2018
Actual Primary Completion Date :
Nov 30, 2020
Actual Study Completion Date :
Feb 28, 2021

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Safety of B001 as assessed by adverse reactions and events [42 days]

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

Secondary Outcome Measures

  1. Concentration-time curve of B001 [112 days]

    Measure the concentration of B001 in serum at different time point to get a concentration-time curve.

  2. PD results of B001 [112 days]

    Measure the number of CD19 positive B cell in peripheral blood

  3. Immunogenicity of B001 [112 days]

    Content analysis of anti-B001 antibody

  4. ORR of B001 [112 days]

    Objective response rate according to Response Criteria for Lymphoma（not including PET）and CLL Response Criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. 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.

  2. Rituximab or any other anti-CD20 monoclonal antibody treatment within 3 weeks.

  3. received blood transfusion and hemopoietic stimulating factor,eg. colony-stimulating factor (CSF)、Erythropoietin(EPO) within 2 weeks.

  4. Radiotherapy within 3 months.

  5. Major surgery within 28 days

  6. History of tumor vaccine treatment.

  7. Live-virus (live attenuated) vaccine treatment within 28 days

  8. High dose of steroid treatment (hydroprednisone >10mg/day or relevant dose of other drugs)

  9. Patients with history of hematopoietic stem cell transplantation or planning to receive hematopoietic stem cell transplantation within 3 months.

  10. Patients with history of Gastrointestinal perforation and/or fistula within 6 months.

  11. Lymphoma in CNS, ADIS related lymphoma

  12. Active infection by bacteria,virus,fungus which required hospitalization or severe infection required intravenous administration of antibiotics

  13. 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,

  1. HBsAg positive; HBcAb positive and HBV-DNA≥upper limit of detection, HCV positive; HIV positive

  2. Allergy to humanized antibody or human-mouse chimeric antibody.

  3. Woman who are breast feeding or pregnant

  4. Judgment by the investigator that the patient should not participate in the study

Contacts and Locations

Locations

Site City State Country Postal Code
1 The second affiliated hospital of Guangzhou medical university Guangzhou Guangdong China
2 Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Tianjin Tianjin China 300020

Sponsors and Collaborators

  • Shanghai Pharmaceuticals Holding Co., Ltd

Investigators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Pharmaceuticals Holding Co., Ltd
ClinicalTrials.gov Identifier:
NCT03332121
Other Study ID Numbers:
  • B001-101
First Posted:
Nov 6, 2017
Last Update Posted:
Nov 15, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell

Study Results

No Results Posted as of Nov 15, 2021