Lymphoma
Conditions
Interventions
Case series:Intravenous infusion IMM01
Sponsors
Hematology Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. voluntarily sign an informed consent form, understand the study and are willing to follow and able to complete all testing procedures; 2. Male or female, age >= 18 years old, =4 cycles by current standard or common regimen, tumor shrinkage less than 50%, or disease progression during the period; (2) partial or complete remission after treatment with current standard or common regimen, and recurrence within six months after stopping treatment; (Current standard treatment and efficacy evaluation criteria are shown in Annex 1, 2, 3, 4) 5. US Eastern Oncology Cooperative Group (ECOG) scores patients with a physical status of 0 to 2; (Annex 5); 6. Expected to live for at least 3 months; 7. If you have received anti-tumor treatment, the following conditions should be met for the first dose interval: Those who have used chemotherapy drugs in the past need to stop taking drugs for more than 4 weeks Previously, patients who have undergone surgery, targeted therapy(Including anti-CD20 monoclonal antibodies, such as rituximab; CD30 monoclonal antibodies, such as vebutuximab, etc.), Chinese medicine treatment with anti-cancer indications, and palliative radiotherapy need to be treated for more than 4 weeks; Previously, patients who have received Car-T cell therapy or PD-1/PD-L1 monoclonal antibody need to stop taking drugs for at least eight weeks; And have recovered from the toxicity of previous treatment to the US National Cancer Institute General Terminology Standards for Negative Events Version 5.0 (NCI-CTCAE v5.0) Classification =1.0 x 10^9/L (short-acting whitening drug was not used within 1 week, long-acting whitening drug was not used within 3 weeks); Patients did not receive platelet transfusion within 1 week; platelets >=75x10^9/L (no bone marrow infiltration)/ >= 50.0 x 10^9/L (bone marrow infiltration); The patient has not received red blood cell transfusion therapy within 2 weeks; hemoglobin >=90g/L (no bone marrow infiltration)/ >= 70g/L (bone marrow infiltration); Serum creatinine <= 1.5 ULN; AST and ALT <= 2.0 ULN; serum total bilirubin (TBIL) <= 2 ULN; International normalized ratio (INR) <= 2 times ULN, or activated partial thromboplastin time (APPT) <=1.5 times ULN; 9. Male subjects and female subjects of childbearing age should agree to take effective contraceptive measures from the signing of the informed consent form until 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Have received allogeneic hematopoietic stem cell transplantation and other organ transplants; autologous hematopoietic stem cell transplantation has not been more than half a year; 2. participated in other drugs or medical device clinical trials within 4 weeks before the first dose of the study; 3. There are central nervous system metastases; 4. Previous or current malignant tumors (except for cervical cancer of grade IB or lower that has been cured, non-invasive basal cells or squamous cell skin cancer; except for other malignant tumors with complete remission (CR) > 5 years and no anti-tumor within 5 years); 5. Subjects with active or have a history of autoimmune diseases that may recur (eg, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulitis, etc., Annex 6), or high-risk patients (such as those who have received an immunosuppressive treatment for organ transplantation). However, subjects with the following diseases are allowed to enroll: Only need to accept autoimmune hypothyroidism with hormone replacement therapy; Skin diseases (such as eczema, which account for less than 10% of the surface rash) without systemic treatment; 6. Patients who underwent major surgery within 28 days prior to enrollment or who are expected to have major surgery during the 21-day screening period during the study period; 7. Subjects requiring systemic corticosteroids (dose equivalent to >10 mg prednisone/day) or other immunosuppressive drugs within 14 days prior to enrollment or during the study period; admission is permitted in the following cases: Allow subjects to use topical or inhaled glucocorticoids; Allow short-term (1.2×ULN; Oral warfarin, international normalized ratio (INR)>1.2×ULN; 9. Now suffering from acute lung disease, interstitial lung disease or pneumonia (except for local interstitial pneumonia induced by radiotherapy), pulmonary fibrosis, acute lung disease, etc.; 10. Systemic diseases that are not stably controlled by treatment, such as diabetes, severe organic cardiovascular and cerebrovascular diseases, cardiac insufficiency, hypertension, heart block above II, and myocardial infarction within 6 months, and have a cerebral infarction within 6 months, etc.; 11. Positive HIV test; 12. Those who have active tuberculosis during screening; 13. HBsAg(+) patients; HBsAg(-) but HBV-DNA quantification exceeds the upper limit of normal; HCV-Ab (+) patients; HCV-Ab (-) but HCV-RNA quantification exceeds the upper limit of normal; 14. Severe infections occur within 4 weeks prior to the first dose, including but not limited to complications associated with hospitalization, sepsis or severe pneumonia; 15. Patients with uncontrolled active infections requiring oral or intravenous antibiotics; 16. A history of severe allergies, or known subjects who have experienced severe allergic reactions to macromolecular protein preparations/monoclonal antibodies, as well as any test drug components (NCI-CTCAE v5.0 grades greater than grade 3); 17. History of alcoho
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity;Intolerable dose:dose of at least one DLT occurred in 2 or more subjects in the first cycle;Maximum tolerated dose (if applicable); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic index;Anti-drug antibody;Objective response rate;Event-free survival;Progress free survival;overall survival; | — |
Countries
China
Contacts
Public ContactWenzhi Tian
ImmuneOnco Biopharmaceuticals(Shanghai) Co., Ltd
Outcome results
None listed