A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL

NCT05615636 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2022-0459NCI-2022-09576
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

To learn if giving mosunetuzumab in combination with polatuzumab vedotin, tafasitamab, and lenalidomide can help to control relapsed/refractory FL and DLBCL.

Conditions

Hodgkin Lymphoma; B-Cell Lymphoma; Relapsed B-cell NHL

Outcome Measures

Primary Outcomes (1)

• The best overall response rate (ORR).

  through study completion; an average of 1 year.

Study Arms (2)

Safety Run In

EXPERIMENTAL

During the safety run-in, the study team will first test a recommended dose of mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide.

Drug: Mosunetuzumab; Drug: Polatuzumab vedotin; Drug: Tafasitamab; Drug: Lenalidomide

Dose Expansion Cohort

EXPERIMENTAL

Participants will receive mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide at the dose level that was found tolerated in the safety run-in.

Drug: Mosunetuzumab; Drug: Polatuzumab vedotin; Drug: Tafasitamab; Drug: Lenalidomide

Interventions

Mosunetuzumab DRUG

Given by IV (vein)

Also known as: RO7030816

Dose Expansion Cohort; Safety Run In

Polatuzumab vedotin DRUG

Given by IV (vein)

Dose Expansion Cohort; Safety Run In

Tafasitamab DRUG

Given by IV (vein)

Dose Expansion Cohort; Safety Run In

Lenalidomide DRUG

Given by PO

Also known as: CC-5013, Revlimid

Dose Expansion Cohort; Safety Run In

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Adequate hematologic function (unless abnormalities are related to NHL), defined as follows:
• Hemoglobin ≥ 9.0 g/dL
• Absolute neutrophil count ≥ 1.0 x 109/L
• Platelet count ≥ 75 x 109/L
• Serum bilirubin \<1.5x ULN except in patients with Gilbert fs syndrome as defined by \> 80% unconjugated bilirubin who must have a serum bilirubin of \<4x ULN; AST (SGOT) and ALT (SGPT) ≤ 3x ULN or \< 5x ULN if hepatic metastases are present

You may not qualify if:

• 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)
• Regular treatment with corticosteroids during the 2 weeks prior to the start of Cycle 1, unless administered for indications other than NHL at a dose equivalent to \< 20 mg/day prednisone. Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone (20 mg), azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1. The use of inhaled corticosteroids is permitted The use of mineralocorticoids for management of orthostatic hypotension is permitted. Single dose of dexamethasone for nausea or B symptoms is permitted
• Prior systemic treatment with chemotherapy, immunotherapy, targeted and biologic therapy 4 weeks prior to C1D1.
• Prior treatment with radiotherapy within 2 weeks prior to C1D1. If patients have received radiotherapy within 4 weeks prior to the initiation of study treatment, patients must have at least one measurable lesion outside of the radiation field. Patients who have only one measurable lesion that was previously irradiated but subsequently progressed are eligible.
• History of prior malignancy within the last 2 years, except for curatively treated basal or squamous cell carcinoma of the skin and low- grade in situ carcinoma of the cervix
• Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results including but not limited to uncontrolled hypertension, uncontrolled congestive heart failure within past 6 months prior to screening (Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification), uncontrolled or symptomatic arrhythmias with corrected QT interval (QTc) \> 480 msec at screening, uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, COPD, LVEF less than 40%, renal failure, uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura active infection, history of invasive fungal infection, moderate to severe hepatic disease (Child Pugh Class B or C), active hemorrhage, laboratory abnormality, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form. Patients with history of cardiac arrhythmias should have cardiac evaluation and clearance.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, B-Cell

Interventions

polatuzumab vedotin; tafasitamab; Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jason Westin, MD, MS, FACP

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Westin, MD, MS, FACP

CONTACT

713-792-3750; jwestin@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: April 28, 2023
• Primary Completion (Estimated): August 19, 2027
• Study Completion (Estimated): August 19, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)