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

• Status: Not yet recruiting
• Trial end date: 2027-02-28
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multicentre study too Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MorphoSys AG
• Treatments: Lenalidomide

Criteria

Major Inclusion Criteria:

1. Capable of giving signed informed consent

2. Age >18 years

3. Histologically confirmed diagnosis of DLBCL

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

5. 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

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

7. 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 ≥50 mL/minute

Major 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

• primary refractory DLBCL

• 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.

• 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 CD19-targeted therapy or 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