Status:
COMPLETED
B001 in Patients With CD20 Positive B-cell Non Hodgkin's Lymphoma
Lead Sponsor:
Shanghai Pharmaceuticals Holding Co., Ltd
Conditions:
CD20 Positive B Cell Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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 wi...
Detailed Description
Phase I dose escalation study
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- High dose of steroid treatment (hydroprednisone \>10mg/day or relevant dose of other drugs)
- Patients with history of hematopoietic stem cell transplantation or planning to receive hematopoietic stem cell transplantation within 3 months.
- Patients with history of Gastrointestinal perforation and/or fistula within 6 months.
- Lymphoma in CNS, ADIS related lymphoma
- Active infection by bacteria,virus,fungus which required hospitalization or severe infection required intravenous administration of antibiotics
- 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,
- HBsAg positive; HBcAb positive and HBV-DNA≥upper limit of detection, HCV positive; HIV positive
- Allergy to humanized antibody or human-mouse chimeric antibody.
- Woman who are breast feeding or pregnant
- Judgment by the investigator that the patient should not participate in the study
Key Trial Info
Start Date :
March 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03332121
Start Date
March 22 2018
End Date
February 28 2021
Last Update
November 15 2021
Active Locations (2)
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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 Municipality, China, 300020