Clinical trial · Interventional
Phase 2 Study of Plamotamab Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Relapsed or Refractory (R/R) Diffuse Large-cell B-cell Lymphoma (DLBCL)
A Phase 2 Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of XmAb13676 (Plamotamab) Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
NCT05328102CI-TRIAL-00076609terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study has been terminated early by the sponsor due to business decision.
Summary
Brief summary (as posted)
The purpose of this study is to investigate the safety and effectiveness of plamotamab when it is given with tafasitamab and lenalidomide in participants with relapsed or refractory DLBCL.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large-cell B-cell Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Plamotamab | Biological | — | UNRESOLVED |
| Tafasitamab | Biological | Tafasitamab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part 1A: Plamotamab (lower dose), Tafasitamab, and Lenalidomide
- description
- Drug: Plamotamab will be administered at a lower dose in addition to tafasitamab (12 milligrams \[mg\]/kilograms \[kg\] intravenously) plus lenalidomide (25 mg orally). This cohort was planned to enroll sequentially prior to Part 1B.
- interventionNames
- Biological: Plamotamab
- Biological: Tafasitamab
- Drug: Lenalidomide
- type
- EXPERIMENTAL
- label
- Part 1B: Plamotamab (target dose), Tafasitamab, and Lenalidomide
- description
- Drug: Plamotamab will be administered at the target dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide (25 mg orally). This cohort was planned to enroll sequentially after Part 1A.
- interventionNames
- Biological: Plamotamab
- Biological: Tafasitamab
- Drug: Lenalidomide
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of DLBCL, not otherwise specified, 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 centimeter (cm) and greatest perpendicular diameter of ≥ 1.0 cm at baseline. The lesion must have a positive finding on positron emission tomography (PET) scan * Ineligible for or refuse hematopoietic stem cell transplantation (HSCT). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Completed vaccination for the SARS-CoV-2 virus prior to study entry * Fertile participants must agree to use 2 highly effective methods of birth control during for at least 6 months (male participants) and 8 months (female participants) after the last dose of study treatment Exclusion Criteria: * Any other histological type of lymphoma, including high-grade B-cell lymphoma, including those with myelocytomatosis oncogene (MYC) and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements primary mediastinal (thymic) large B cell (PMBL) or Burkitt lymphoma * A prior diagnosis of chronic lymphocytic leukemia (CLL) (Richter's Transformation) * Primary central nervous system lymphoma Exclusionary Previous and Current Treatment: * Previously received treatment with an anti-CD20 × anti-CD3 bispecific antibody (bsAb) * Anti-CD20 therapy (for example, rituximab) within 21 days prior to study entry * Participants 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 within 30 days * Required systemic anti-infective therapy for active, intercurrent infections * Participants who have had the following prior therapies or treatments: * Were previously treated with CD19-targeted therapy, including chimeric antigen receptor-T cell (CAR-T), unless current biopsy is CD19+ * Have a history of hypersensitivity to compounds of similar biological or chemical composition to tafasitamab, immunomodulatory imide drugs (IMiDs) * Previous allogenic stem cell transplantation * Have a history of deep venous thrombosis/embolism, threatening thromboembolism * Concurrently use other anticancer or experimental treatments
References
Publications (0)
Data not yet available
No reference posted for this study.