A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL
Overview
- Phase
- Phase 2
- Intervention
- Mosunetuzumab
- Conditions
- Hodgkin Lymphoma
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- The best overall response rate (ORR).
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
To learn if giving mosunetuzumab in combination with polatuzumab vedotin, tafasitamab, and lenalidomide can help to control relapsed/refractory FL and DLBCL.
Detailed Description
Primary Objectives: To determine the safety of mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide in relapsed/refractory NHL. To determine the best overall response rate (ORR) of the combination of mosunetuzumab, with polatuzumab vedotin, tafasitamab, and lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma. Secondary Objectives: To determine the complete response rate, duration of response, progression free survival, and overall survival in patients with DLBCL following treatment with of mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide. To evaluate changes in immune effector cells and the tumor microenvironment following treatment with of mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients in safety run in must meet the following criteria for study entry:
- •A diagnosis of relapsed CD20+ Follicular Lymphoma grade 1-3a
- •A diagnosis of relapsed CD20+ diffuse large B-cell lymphoma
- •Patients in dose expansion must meet the following criteria for study entry:
- •A diagnosis of relapsed CD20+ diffuse large B-cell lymphoma
- •Patients in each component (safety run in and dose expansion) must meet the following criteria for study entry:
- •Evidence of progression or lack of response following at least 1 prior treatment
- •Able and willing to provide written informed consent and to comply with the study protocol
- •Age ≥ 18 years as these drugs have not yet established safety and efficacy in pediatric patients
- •At least 1 site of measurable disease greater than 1.5cm
Exclusion Criteria
- •Known hypersensitivity to any study drug
- •Prior treatment with polatuzumab vedotin
- •Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies
- •Prior treatment with tafasitamab and/or lenalidomide
- •Autologous SCT within 100 days prior to first study treatment administration
- •Prior treatment with CAR-T therapy within 30 days before first study treatment administration
- •Current eligibility for autologous SCT in patients with R/R DLBCL
- •Prior allogeneic SCT
- •Prior solid organ transplantation
- •History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
Arms & Interventions
Safety Run In
During the safety run-in, the study team will first test a recommended dose of mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide.
Intervention: Mosunetuzumab
Safety Run In
During the safety run-in, the study team will first test a recommended dose of mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide.
Intervention: Polatuzumab vedotin
Safety Run In
During the safety run-in, the study team will first test a recommended dose of mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide.
Intervention: Tafasitamab
Safety Run In
During the safety run-in, the study team will first test a recommended dose of mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide.
Intervention: Lenalidomide
Dose Expansion Cohort
Participants will receive mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide at the dose level that was found tolerated in the safety run-in.
Intervention: Mosunetuzumab
Dose Expansion Cohort
Participants will receive mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide at the dose level that was found tolerated in the safety run-in.
Intervention: Polatuzumab vedotin
Dose Expansion Cohort
Participants will receive mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide at the dose level that was found tolerated in the safety run-in.
Intervention: Tafasitamab
Dose Expansion Cohort
Participants will receive mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide at the dose level that was found tolerated in the safety run-in.
Intervention: Lenalidomide
Outcomes
Primary Outcomes
The best overall response rate (ORR).
Time Frame: through study completion; an average of 1 year.