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

Major Inclusion Criteria:

• Capable of giving signed informed consent
• Age 18 years or older
• Histologically confirmed diagnosis of DLBCL
• Tumor tissue for retrospective central pathology review must be provided as an adjunct to participation in this study.
• Patients must have:

• relapsed and/or refractory disease
• at least one bidimensionally measurable, PET positive disease site (transverse diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline)
• received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must have included a CD20-targeted therapy
• Eastern Cooperative Oncology Group 0 to 2
• Patients not considered in the opinion of the investigator eligible to undergo intensive salvage therapy including ASCT
• Patients must meet the following laboratory criteria at screening:

• absolute neutrophil count ≥1.5 × 10^9/L
• platelet count ≥90 × 10^9/L
• total serum bilirubin ≤2.5 × ULN or ≤5 × ULN in cases of Glibert's Syndrome or liver involvement by lymphoma
• alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 × ULN or <5 × ULN in cases of liver involvement
• serum creatinine clearance ≥ 60 mL/minute
• Patients who received previous CD19 targeted therapy (other than tafasitamab) must have CD19 positive lymphoma confirmed on a biopsy taken since completing the prior CD19 targeted therapy
• Patients with primary refractory disease who received at least one, but no more than three previous systemic regimens (including a CD20 targeted therapy)

Major Exclusion Criteria:

• Patients who are legally institutionalized or concurrent enrollment in another interventional clinical study
• Patients who have:

• other histological type of lymphoma
• a history of "double/triple hit" genetics
• 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
• 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
• 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
• 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
• 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