AzTrials
AzTrials

Hodgkin LymphomaPhase 2NCT05615636

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

A Phase 2 study testing Mosunetuzumab, Polatuzumab vedotin and Tafasitamab in people with Hodgkin Lymphoma and B-Cell Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Mosunetuzumab, Polatuzumab vedotin and Tafasitamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited States
Study dates
28 Apr 2023to 19 Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 23Show fewer
  • 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
  • Renal function assessed by calculated creatinine clearance:
  • . Calculated creatinine clearance ≥30ml/min by Cockcroft-Gault formula. See section below, "Dosing Regimen", regarding lenalidomide dose adjustment for calculated creatinine clearance ≥30ml/min and < 60ml/min.
  • Patients must be willing to receive transfusions of blood products.
  • For men who are not surgically sterile, agreement to use a barrier method of contraception for ≥ 3 months after the last treatment dose. In addition, male patients must agree to request that their partners use an additional method of contraception, such as oral contraceptives, intrauterine device, barrier method of contraception, or spermicidal jelly. With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for 60 days after the final dose of mosunetuzumab, 6 months after the final dose of polatuzumab vedotin, and 60 days after the final dose of tocilizumab, as applicable, to avoid exposing the embryo. Men must refrain from donating sperm during this same period.
  • For women of reproductive potential who are not surgically sterile, agreement to use two adequate methods of contraception, such as oral contraceptives, intrauterine device, or barrier method of contraception in conjunction with spermicidal jelly for ≥ 12 months after the last therapeutic drug dose
  • Females of childbearing potential (FCBP, defined as a female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2)has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). must have a negative serum pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a female of childbearing potential even if they have had a successful vasectomy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women must refrain from donating eggs during this same period.
  • All study participants must be registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of Revlimid REMS® program.
  • Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).

Who cannot join

  • 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
Show all 34Show fewer
  • 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.
  • Known or suspected history of hemophagocytic lymphohistiocytosis
  • History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible. Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study. Patients with a history of disease-related immune thrombocytopenic purpura, autoimmune hemolytic anemia, or other stable autoimmune diseases may be eligible after review and approval by the Medical Monitor.
  • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics, except if for tumor fever) within 2 weeks prior to the start of cycle 1
  • Patients with suspected active or latent tuberculosis (latent tuberculosis needs to be confirmed by positive Interferon-gamma release assay)
  • Known or suspected chronic active Epstein-Barr virus (EBV) infection
  • Known HIV infection. Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative DNA polymerase chain reaction (PCR) and must be willing to undergo DNA PCR testing during the study to be eligible. Those who are HBsAg positive or hepatitis B DNA PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative DNA PCR result to be eligible. Those who are hepatitis C DNA PCR positive will be excluded.
  • Vaccination with live vaccines within 28 days prior to start of treatment
  • No peripheral neuropathy ≥ grade 2 or = grade 2 with pain
  • Pregnant or lactating females.
  • Women of childbearing potential must have a negative serum (-human chorionic gonadotropin [-hCG]) at screening and must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
  • All patients with known central nervous system involvement with lymphoma.
  • Contraindication to any of the required concomitant drugs or supportive treatments or intolerance to hydration due to preexisting pulmonary or cardiac impairment including pleural effusion requiring thoracentesis or ascites requiring paracentesis not due to lymphoma.
  • Patients with active pulmonary embolism or deep vein thrombosis (diagnosed within 30 days of study enrollment).
  • Major surgery within 4 weeks of study entry, or wound that is not healed from prior surgery or trauma.
  • History of stroke or intracranial hemorrhage within 6 months prior to study entry.
  • Active bleeding or history of bleeding diathesis (eg, hemophilia or von Willebrand disease).
  • Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenic purpura).
  • Prothrombin time (PT)/INR or aPTT (in the absence of lupus anticoagulant) >2x ULN.
  • Concurrent participation in another therapeutic clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jason Westin, MD, MS, FACP contact

713-792-3750

jwestin@mdanderson.org

United States1 site, 1 recruiting

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    Jason Westin, MD, MS, FACP, 713-792-3750, jwestin@mdanderson.org

    Jason Westin, MD, MS, FACP

    Recruiting

Other trials in United States

About this study

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

Read the 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.

Being tested
Mosunetuzumab, Polatuzumab vedotin, Tafasitamab, Lenalidomide
Medical subject headings
Hodgkin Disease, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MosunetuzumabDrug

    Also called RO7030816

    Given by IV (vein)

  • Polatuzumab vedotinDrug

    Given by IV (vein)

  • TafasitamabDrug

    Given by IV (vein)

  • LenalidomideDrug

    Also called CC-5013, Revlimid

    Given by PO

Study groups in NCT05615636
Study groupRoleWhat they receive
Safety Run InExperimentalDuring the safety run-in, the study team will first test a recommended dose of mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide.
Receives: Drug: Mosunetuzumab; Drug: Polatuzumab vedotin; Drug: Tafasitamab; Drug: Lenalidomide
Dose Expansion CohortExperimentalParticipants will receive mosunetuzumab, polatuzumab vedotin, tafasitamab, and lenalidomide at the dose level that was found tolerated in the safety run-in.
Receives: Drug: Mosunetuzumab; Drug: Polatuzumab vedotin; Drug: Tafasitamab; Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The best overall response rate (ORR).

    Measured: through study completion; an average of 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2022
  2. Study start28 Apr 2023
  3. Primary completion19 Aug 2027 (estimated)
  4. Study completion19 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05615636
Sponsor's protocol ID
2022-0459
Other IDs
NCI-2022-09576
Status last verified
Sep 2026
First submitted
7 Nov 2022
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Duell J, Westin J. The future of immunotherapy for diffuse large B-cell lymphoma. Int J Cancer. 2025 Jan 15;156(2):251-261. doi: 10.1002/ijc.35156. Epub 2024 Sep 25.

    PubMed 39319495

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mosunetuzumab, Polatuzumab vedotin and Tafasitamab in people with Hodgkin Lymphoma and B-Cell Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jason Westin, MD, MS, FACP (713-792-3750, jwestin@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The best overall response rate (ORR). (time frame: through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05615636, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in