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

Sponsor
Xencor, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05328102
Collaborator
(none)
240
1
3
108
2.2

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

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Part 1 Single Arm Multiple Dose Followed by Part 2 RandomizedPart 1 Single Arm Multiple Dose Followed by Part 2 Randomized
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Jun 30, 2022
Anticipated Primary Completion Date :
Jan 1, 2027
Anticipated Study Completion Date :
Jun 30, 2031

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

  1. For Part 1: safety as measured by incidence of Treatment Emergent Adverse Events (TEAEs), including Cytokine Release Syndrome (CRS) [4 months]

  2. For Part 2: Progression-free Survival (PFS) [Up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Xencor, Inc.
ClinicalTrials.gov Identifier:
NCT05328102
Other Study ID Numbers:
  • XmAb13676-03
First Posted:
Apr 14, 2022
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xencor, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2022