A Study to Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide in Patients with Worsening (relapsed) or Unresponsive (refractory) Diffuse Large B-Cell Lymphoma (R/R DLBCL) (MINDway)

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• 1. General provisions: a. Patients who are legally institutionalized, or patients under judicial protection b. Concurrent enrollment in another interventional clinical study 2. Patients who have: a. Any other histological type of lymphoma including primary mediastinal (thymic) large B-cell (PMBL) or Burkitt lymphoma b. Known “double/triple hit” genetics (high grade B-cell lymphoma) characterized by simultaneous detection of MYC with BCL2 and/or BCL6 translocation(s) defined by fluorescence in situ hybridization. MYC, BCL2, BCL6 testing prior to study enrollment is not required 3. Patients who have: a. Not discontinued (within 14 days prior to Day 1 dosing): CD20 targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma-specific therapy b. Undergone major surgery (within 4 weeks prior to Day 1 dosing) or suffered from significant traumatic injury c. Received live vaccines (within 4 weeks prior to Day 1 dosing) (See Appendix 7: Covid-19: Infection Prophylaxis and Vaccines) d. Required parenteral antimicrobial therapy for active, intercurrent infections (within 14 days prior to Day 1 dosing) 4. Patients who: a.Have, in the opinion of the investigator, not recovered sufficiently from the adverse toxic effects of prior therapies b. Were previously treated with tafasitamab or IMiDs® (e.g., thalidomide, LEN) c. Have a history of hypersensitivity to compounds of similar biological or chemical composition to tafasitamab, IMiDs® and/or the excipients contained in the study treatment formulations d. Have undergone ASCT within the period ≤ 3 months prior to signing the ICF. Patients who have a more distant history of ASCT must exhibit full hematological recovery before enrollment into the study e. Have undergone previous allogenic stem cell transplantation f.Have a history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or are at high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to take venous thromboembolism (VTE) prophylaxis during the entire treatment period g. Concurrently use other anticancer or experimental treatments
• 5. History of other malignancy that could affect compliance with the protocol or interpretation of results. Exceptions:a. 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 b. 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: a. Positive hepatitis B and/or C serology (see Appendix 8: Hepatitis Virus Serology for details) b. Known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV) c.Central nervous system (CNS) lymphoma involvement – present or past medical history d. 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 e. History or evidence of rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption f. Gastrointestinal (GI) abnormalities (issue with absorption) including the inability to take oral medication g. History or evidence of severe hepatic impairment (total serum bilirubin > 3 mg/dL), jaundice unless secondary to Gilbert’s syndrome or documented liver involvement by lymphoma (see inclusion criterion 7c) h. History of hypersensitivity to any of the study treatments or its excipients or to drugs of similar chemical class i. Any other medical condition which, in the investigator’s opinion, makes the patient unsuitable for the study
• 7. Contraception provisions: Females: Due to the teratogenic potential of LEN, FCBP must follow the rules listed below (otherwise excluded): a. Not be pregnant as confirmed by a negative serum pregnancy test at screening and a medically supervised urine pregnancy test prior to starting study therapy b. Refrain from breast feeding and donating oocytes during the study and for 3 months after the last dose of study drug or according to local guidelines for LEN, whichever is longer c. Agree to ongoing pregnancy testing during the course of the study, and after study treatment has ended. This includes pregnancy testing and counseling if a patient misses her period or if there is any abnormality in her menstrual bleeding and applies even if the patient practices complete sexual abstinence d. Commit to continued abstinence from heterosexual intercourse if it is in accordance with her lifestyle (which must be reviewed on a monthly basis) or agree to use and be able to comply with the use of highly effective contraception without interruption at least 4 weeks prior to start of study drugs, during the study treatment and for 3 months after the last dose of study drug, or, for LEN, according to the local guidelines, whichever is longer. 8. Due to the teratogenic potential of lenalidomide, male participants must follow the rules listed below (otherwise excluded):a. Use an effective barrier method of contraception without interruption if the patient is sexually active with a FCBP. Male patients should refrain from donating sperm during the study participation and for 3 months after the last dose of study treatment, or according to the local guidelines for LEN, whichever is longer.