Phase 2 Study of Plamotamab Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in R/R DLBCL

• Status: Not yet recruiting
• Trial end date: 2031-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the safety and effectiveness of plamotamab when it is given with tafasitamab and lenalidomide in relapsed or refractory DLBCL.

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

Details

• Lead Sponsor: Xencor, Inc.
• Treatments: Lenalidomide

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of DLBCL, NOS, including DLBCL arising from low grade lymphoma

• CD20+ and CD19+ lymphoma

• Archival paraffin embedded tumor tissue or unstained slides must be available for retrospective cell of origin determination

• Relapsed or refractory

• At least 1 prior systemic line(s) of therapy, one of which must have included multi-agent chemoimmunotherapy that includes an anti-CD20 monoclonal antibody.

• At least 1 bidimensionally measurable disease site. The lesion must have a greatest transverse diameter of ≥ 1.5 cm and greatest perpendicular diameter of ≥ 1.0 cm at baseline. The lesion must have a positive finding on PET scan

• Ineligible for or refuse hematopoietic stem cell transplantation (HSCT).

• ECOG) performance status of 0 to 2

• Completed vaccination for the SARS-CoV-2 virus prior to study entry

• Fertile subjects must agree to use 2 highly effective methods of birth control during for at least 6 months (male subjects) and 8 months (female subjects) after the last dose of study treatment

Exclusion Criteria:

• Any other histological type of lymphoma, including high-grade B-cell lymphoma, including those with MYC and BCL2 and/or BCL6 rearrangements primary mediastinal (thymic) large B cell (PMBL) or Burkitt lymphoma

• A prior diagnosis of CLL (Richter's Transformation)

• Primary central nervous system (CNS) lymphoma

Exclusionary Previous and Current Treatment:

• Previously received treatment with an anti-CD20 × anti-CD3 bsAb

• Anti-CD20 therapy (eg, rituximab) within 21 days prior to study entry

• Subjects who have, within 14 days prior study entry:

• Chemotherapy, radiotherapy, or other lymphoma-specific therapy not including anti CD20 therapy

• Small molecule or investigational anticancer agents within 6 elimination half-lives

• Received live vaccines (see Section 7.2 for details) within 30 days

• Required systemic anti-infective therapy for active, intercurrent infections

• Subjects who have had the following prior therapies or treatments:

• Were previously treated with CD19-targeted therapy, including CAR-T, unless current biopsy is CD19+

• Have a history of hypersensitivity to compounds of similar biological or chemical composition to tafasitamab, IMiDs

• Previous allogenic stem cell transplantation

• Have a history of deep venous thrombosis/embolism, threatening thromboembolis

• Concurrently use other anticancer or experimental treatments