refractory or relapsed CD20-positive (CD20+) B-cell non-Hodgkin's lymphoma
Conditions
Interventions
Case series:Intravenous infusion IMM0306
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. To sign the informed consent voluntarily, to understand the research and willing to follow and able to complete all test procedures; 2. Male or female aged 18 or older; 3. Relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) that has been diagnosed, including but not limited to diffuse large B-cell lymphoma (DLBCL) Follicular lymphoma (FL), mucosal lymphoma (MALT-L), small lymphocytic lymphoma (SLL) / chronic lymphocytic leukemia (CLL), etc.Indolent B-NHL must have received at least one-line standard treatment failure, and aggressive B-NHL must have received a second-line or above standard treatment failure; a) Recurrence refers that patients have the progression of the disease after sufficient treatment to achieve remission, who have at least one of the regimens contains anti-CD20 monoclonal antibody monotherapy or combination therapy, classified as CLL/SLL type need to have received ibrutinib treatment. "Remission" includes complete remission and partial remission; b) Refractory is defined as: no response to standard treatment (for example, including anti-CD20 monoclonal antibody monotherapy or combination therapy, patients classified as CLL/SLL need to have received ibrutinib treatment or ibrutinib intolerance) , Including: the best response to standard treatment is disease progression (PD); or the best response to standard treatment is stable disease (SD) and the maintenance time does not exceed 6 months after the last administration; 4. At least one measurable or assessable tumor lesion at phase Ia,at least one assessable tumor lesion at Phase Ib; measurable lesions: the longest diameter of the lymph nodes is >= 15mm, and the metastatic lesions in other parts are >= 10mm; if the lesion has been previously treated with local treatment such as radiotherapy, if the disease has been proven to be progressed, it is considered measurable lesions 5. Patients with a physical fitness status of 0 to 1 by the Eastern Cooperative Oncology Group (ECOG) score; 6. Expected survival of at least 3 months; 7. The interval between the first dosing of the previous anti-tumor therapy and the first dose of this study should meet the following conditions: If have received anti-CD20 monoclonal antibodies in the past, patient need to stop the drug for more than 4 weeks; If have used chemotherapy drugs in the past, patient need to stop the drug for more than 3 weeks; If have previously received small molecule targeted therapy, patient need to stop the drug for more than 1 week or 5 drug half-lives (whichever is longer); If have previously received immune checkpoint inhibitor therapy, patient need to stop the drug for more than 8 weeks; Those who have previously received surgery, palliative radiotherapy, and other anti-tumor drugs (including macromolecular targeted drugs, immunomodulators, Chinese patent medicines with clear anti-tumor effects and non-Hodgkins lymphoma indications, etc.) need to be separated more than 4 weeks; 8. CTCAE v5.0 grade score = 1.0x10^9/L (no short-acting whitening drug used within 1 week before the first dose and no long-acting whitening drug used within 3 weeks before the first dose); The patient has not received platelet transfusion therapy within 1 week before the first dose; platelets >= 75x10^9/L
Exclusion criteria
Exclusion criteria: 1. Active central nervous system (CNS) lymphoma (patients with CNS disease symptoms must undergo lumbar puncture and MRI to rule out CNS lymphoma); 2. Those who have received allogeneic hematopoietic stem cell transplantation and other organ transplants (except those who have undergone autologous hematopoietic stem cell transplantation) and those who have received CAR-T cell therapy; 3. Receiving live attenuated vaccine within 4 weeks before the first dose of study treatment or during the study period; 4. Patients with a history of malignant tumors in the past 5 years except any malignant tumor patient with basal cell carcinoma of the skin or squamous cell carcinoma of the skin, melanoma in situ, and carcinoma in situ of the cervix completely responded and/or responded without disease or for at least 5 consecutive years without disease; 5. Subjects with active or history of autoimmune diseases (eg: systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple Sclerosis, vasculitis, glomerulitis, etc.), or patients at high risk (such as undergoing organ transplantation requiring immunosuppressive therapy). Subjects with the following diseases are allowed: Autoimmune hypothyroidism who only needs hormone replacement therapy; Skin diseases that do not require systemic treatment (such as eczema, rashes that account for less than 10% of the body's surface); 6. Patients who underwent major surgery within 28 days before first dose expected major surgery during the study period ; 7. Subjects have deep vein embolism or pulmonary embolism within 6 months before screening; 8. Subjects who need to receive systemic corticosteroids (dose equivalent to > 10 mg prednisone / day) or other immunosuppressive drugs within 7 days before or during the first dose of study treatment, but do not include nasal spray, inhalation or other routes of local glucocorticoids or physiological doses of systemic glucocorticoids; 9. Patients need take long-term oral administration of aspirin or other non-steroidal anti-inflammatory drugs, clopidogrel and other drugs that inhibit platelet aggregation (except for that the investigator assesses that the treatment can be suspended and patients who meet the enrollment); 10. Currently suffering from acute lung disease, interstitial lung disease or pneumonia,E.g. interstitial pneumonia (except for localized interstitial pneumonia induced by radiotherapy), pulmonary fibrosis, etc .; 11. Treatment of systemic diseases that are not stably controlled, such as diabetes, severe organic cardio-cerebrovascular diseases; 12. The patient's heart meets any of the following conditions: Left ventricular ejection fraction (LVEF) = 450ms for men and 470ms for women (QTcB = QT/RR1/2); Myocardial infarction or bypass or stent surgery within 6 months before dose; Other heart diseases judged not to be eligible by the investigator; 13. Human immunodeficiency virus (HIV) infection, positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) during the screening period, and HBV-DNA is higher than the measurable lower limit; during the screening period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety outcome;Pharmacokinetic outcome; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity outcome;Efficacy outcome;Exploratory outcome; | — |
Countries
China
Contacts
Public ContactWenzhi Tian
ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd
Outcome results
None listed