Phase 2 Study of Plamotamab Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in R/R DLBCL
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
This is a randomized, multicenter, open-label, Phase 2 study of plamotamab combined with tafasitamab plus lenalidomide versus tafasitamab plus lenalidomide in adult subjects with DLBCL who have relapsed after or are refractory to at least 1 prior line of therapy, which must have included multi-agent chemoimmunotherapy inclusive of an anti-CD20 monoclonal antibody, and who are not candidates for ASCT, refuse ASCT, or relapse after ASCT.
The study will enroll and evaluate subjects in a single arm for safety and determination of dose and dose schedule.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Part 1 Drug: plamotamab administered at protocol defined dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide (25mg p.o.) |
Biological: plamotamab
Biological
Biological: tafasitamab
Biological
Drug: lenalidomide
Drug
|
Experimental: Part 2 Drug: plamotamab administered at protocol defined dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide 25mg (p.o.) |
Biological: plamotamab
Biological
Biological: tafasitamab
Biological
Drug: lenalidomide
Drug
|
Active Comparator: Part 2B Drug: tafasitamab (12 mg/kg intravenously) plus lenalidomide 25mg (p.o.) |
Biological: tafasitamab
Biological
Drug: lenalidomide
Drug
|
Outcome Measures
Primary Outcome Measures
- For Part 1: safety as measured by incidence of Treatment Emergent Adverse Events (TEAEs), including Cytokine Release Syndrome (CRS) [4 months]
- For Part 2: Progression-free Survival (PFS) [Up to 5 years]
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Swedish Cancer Center | Seattle | Washington | United States | 98104 |
Sponsors and Collaborators
- Xencor, Inc.
Investigators
- Study Director: Steve Kye, MD, Executive Medical Director, Clinical Development
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XmAb13676-03