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

Major Inclusion Criteria:

1. Capable of giving signed informed consent

2. Age 18 years or older

3. Histologically confirmed diagnosis of DLBCL

4. Tumor tissue for retrospective central pathology review must be provided as anadjunct to participation in this study.

5. Patients must have:

• relapsed and/or refractory disease

• at least one bidimensionally measurable, PET positive disease site (transversediameter 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 forthe treatment of DLBCL and one therapy line must have included a CD20-targetedtherapy

• Eastern Cooperative Oncology Group 0 to 2

6. Patients not considered in the opinion of the investigator eligible to undergointensive salvage therapy including ASCT

7. 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 orliver 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

8. Patients who received previous CD19 targeted therapy (other than tafasitamab) musthave CD19 positive lymphoma confirmed on a biopsy taken since completing the priorCD19 targeted therapy

9. Patients with primary refractory disease who received at least one, but no more thanthree previous systemic regimens (including a CD20 targeted therapy)

Major Exclusion Criteria:

1. Patients who are legally institutionalized or concurrent enrollment in anotherinterventional 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 traumaticinjury

• 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 priortherapies

• were previously treated with IMiDs® (e.g. thalidomide, LEN)

• have history of hyper sensitivity to compounds of similar biological orchemical composition to tafasitamab IMiDs® and/or the excipients contained inthe study treatment formulations

• have undergone ASCT within the period ≤ 3 months prior to signing the informedconsent form.

• have undergone previous allogenic stem cell transplantation

• have a history of deep venous thrombosis/embolism and who are not willing/ableto take venous thromboembolic event prophylaxis during the entire treatmentperiod

• concurrently use other anticancer or experimental treatments

5. History of other malignancy that could affect compliance with the protocol orinterpretation of results. Exceptions

• Patients with any malignancy appropriately treated with curative intent and themalignancy has been in remission without treatment for >2 years prior toenrollment 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 areeligible

6. Patients with:

• positive hepatitis B and/or C serology.

• known seropositivity for or history of active viral infection with humanimmunodeficiency virus (HIV)

• CNS lymphoma involvement

• history or evidence of clinically significant cardiovascular, CNS and/or othersystemic disease that would in the investigator's opinion precludeparticipation in the study or compromise the patient's ability to give informedconsent

• history or evidence of rare hereditary problems of galactose intolerance, theLapp lactase deficiency or glucose-galactose malabsorption

• gastrointestinal (GI) abnormalities (issue with absorption) including theinability 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 liverinvolvement by lymphoma

• history of hypersensitivity to any of the study treatments or its excipients orto drugs of similar chemical class

• any other medical condition which, in the investigator's opinion, makes thepatient unsuitable for the study

7. Female participants: Agreement to remain abstinent (refrain from heterosexualintercourse) or use contraceptive methods and refrain from breast feeding anddonating eggs; agreement to ongoing pregnancy testing during the course of thestudy, and after study therapy has ended Male participants: agreement to remainabstinent (refrain from heterosexual intercourse) or use a condom and agreement torefrain from donating sperm