Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients

Exclusion Criteria

• •1. Patients who are legally institutionalized or concurrent enrollment in another interventional clinical study
• •2. Patients who have:
• •* other histological type of lymphoma
• •* a history of "double/triple hit" genetics
• •3. Patients who have, within 14 days prior to Day 1 dosing:
• •* not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
• •* undergone major surgery (with 4 weeks) or suffered from significant traumatic injury
• •* received live vaccines (within 4 weeks).
• •* required parenteral antimicrobial therapy for active, intercurrent infections
• •4. Patients who:
• •* have not recovered sufficiently from the adverse toxic effects of prior therapies
• •* were previously treated with IMiDs® (e.g. thalidomide, LEN)
• •* have history of hyper sensitivity to compounds of similar biological or chemical composition to tafasitamab IMiDs® and/or the excipients contained in the study treatment formulations
• •* have undergone ASCT within the period ≤ 3 months prior to signing the informed consent form.
• •* have undergone previous allogenic stem cell transplantation
• •* have a history of deep venous thrombosis/embolism and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period
• •* concurrently use other anticancer or experimental treatments
• •5. History of other malignancy that could affect compliance with the protocol or interpretation of results. Exceptions
• •* Patients with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for \>2 years prior to enrollment are eligible
• •* Patients with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study are eligible
• •6. Patients with:
• •* positive hepatitis B and/or C serology.
• •* known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV)
• •* CNS lymphoma involvement
• •* history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromise the patient's ability to give informed consent
• •* history or evidence of rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
• •* gastrointestinal (GI) abnormalities (issue with absorption) including the inability to take oral medication
• •* history or evidence of severe hepatic impairment (total serum bilirubin \> 3mg/dL), jaundice unless secondary to Gilbert's syndrome or documented liver involvement by lymphoma
• •* history of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical class
• •* any other medical condition which, in the investigator's opinion, makes the patient unsuitable for the study
• •7. Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from breast feeding and donating eggs; agreement to ongoing pregnancy testing during the course of the study, and after study therapy has ended Male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm