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

Primary Purpose

Diffuse Large-cell B-cell Lymphoma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
plamotamab
tafasitamab
lenalidomide
Sponsored by
Xencor, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large-cell B-cell Lymphoma focused on measuring DLBCL, NOS, Diffuse Large B-cell Lymphoma, Transformed indolent Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Swedish Cancer Center
  • CHU de Rennes - Hopital de Pontchaillou
  • Hospital Universitario Virgen de las Nieves

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Part 1

Part 2

Part 2B

Arm Description

Drug: plamotamab administered at protocol defined dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide (25mg p.o.)

Drug: plamotamab administered at protocol defined dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide 25mg (p.o.)

Drug: tafasitamab (12 mg/kg intravenously) plus lenalidomide 25mg (p.o.)

Outcomes

Primary Outcome Measures

For Part 1: safety as measured by incidence of Treatment Emergent Adverse Events (TEAEs), including Cytokine Release Syndrome (CRS)
For Part 2: Progression-free Survival (PFS)

Secondary Outcome Measures

Full Information

First Posted
April 4, 2022
Last Updated
May 5, 2023
Sponsor
Xencor, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05328102
Brief Title
Phase 2 Study of Plamotamab Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in R/R DLBCL
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
The study has been terminated early by the sponsor due to business decision.
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
December 27, 2022 (Actual)
Study Completion Date
February 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xencor, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large-cell B-cell Lymphoma
Keywords
DLBCL, NOS, Diffuse Large B-cell Lymphoma, Transformed indolent Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Part 1 Single Arm Multiple Dose Followed by Part 2 Randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1
Arm Type
Experimental
Arm Description
Drug: plamotamab administered at protocol defined dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide (25mg p.o.)
Arm Title
Part 2
Arm Type
Experimental
Arm Description
Drug: plamotamab administered at protocol defined dose in addition to tafasitamab (12 mg/kg intravenously) plus lenalidomide 25mg (p.o.)
Arm Title
Part 2B
Arm Type
Active Comparator
Arm Description
Drug: tafasitamab (12 mg/kg intravenously) plus lenalidomide 25mg (p.o.)
Intervention Type
Biological
Intervention Name(s)
plamotamab
Intervention Description
Biological
Intervention Type
Biological
Intervention Name(s)
tafasitamab
Intervention Description
Biological
Intervention Type
Drug
Intervention Name(s)
lenalidomide
Intervention Description
Drug
Primary Outcome Measure Information:
Title
For Part 1: safety as measured by incidence of Treatment Emergent Adverse Events (TEAEs), including Cytokine Release Syndrome (CRS)
Time Frame
4 months
Title
For Part 2: Progression-free Survival (PFS)
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Chiarella
Organizational Affiliation
Senior Director, Clinical Science, Clinical Development
Official's Role
Study Director
Facility Information:
Facility Name
Swedish Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
CHU de Rennes - Hopital de Pontchaillou
City
Rennes Cedex
Country
France
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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