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

Launched by SHANGHAI PHARMACEUTICALS HOLDING CO., LTD · Nov 1, 2017

Keywords

ClinConnect Summary

Phase I dose escalation study

Gender

ALL

Eligibility criteria

• 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