A Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

Major Inclusion Criteria:

1. Age >18 years

2. Histologically confirmed diagnosis of DLBCL

3. Tumour tissue for central pathology review and correlative studies must be provided.

4. 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

5. Patients not considered in the opinion of the investigator eligible, or patients
unwilling to undergo intensive salvage therapy including ASCT

6. Patients must meet the following laboratory criteria at screening:

- absolute neutrophil count ≥1.5 × 109/L

- platelet count ≥90 × 109/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

7. Females of childbearing potential (FCBP) must:

- not be pregnant

- refrain from breastfeeding and donating blood or oocytes

- agree to ongoing pregnancy testing

- commit to continued abstinence from heterosexual intercourse, or agree to use and
be able to comply with the use of double-barrier contraception

8. Males (if sexually active with a FCBP) must

- use an effective barrier method of contraception

- refrain from donating blood or sperm

9. In the opinion of the investigator the patients must:

- be able and willing to receive adequate prophylaxis and/or therapy for
thromboembolic events

- be able to understand the reason for complying with the special conditions of the
pregnancy prevention risk management plan and give written acknowledgement of
this.

Major Exclusion Criteria:

1. Patients who have:

- other histological type of lymphoma

- primary refractory DLBCL

- a history of "double/triple hit" genetics

2. 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 or suffered from significant traumatic injury

- received live vaccines.

- required parenteral antimicrobial therapy for active, intercurrent infections

3. Patients who:

- were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide,
LEN)

- 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

4. Prior history of malignancies other than DLBCL, unless the patient has been free of
the disease for ≥5 years prior to screening.

5. 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.