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Lymphoma, FollicularPhase 2NCT05410418

Mosunetuzumab and Polatuzumab Vedotin for Untreated Follicular Lymphoma

A Phase 2 study testing Mosunetuzumab and Polatuzumab vedotin in people with Lymphoma, Follicular and Follicular Lymphoma, run by Washington University School of Medicine at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase II clinical trial studies the combination of mosunetuzumab and polatuzumab vedotin in order to see how well it works in patients with untreated follicular lymphoma. Mosunetuzumab is an antibody that has been engineered to attach to two target cells in the immune system: T cells that normally perform tasks… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Follicular, Follicular Lymphoma
What is being tested?
Mosunetuzumab and Polatuzumab vedotin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
24 Oct 2022to 24 Apr 2029
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Diagnosis of follicular lymphoma grade 1-3A, stage II-IV by Ann Arbor criteria.
  • One or more of the following criteria (adapted from GELF criteria):
  • Any nodal or extranodal tumor mass with diameter > 7 cm
  • Involvement of at least 3 nodal sites, each with diameter > 3 cm
  • Presence of any systemic or B symptoms
  • Splenic enlargement with inferior margin below the umbilical line
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  • Compression syndrome (e.g., ureteral, orbital, gastrointestinal)
  • Pleural or peritoneal serous effusion (irrespective of cell content)
  • Cytopenia(s) attributable to lymphoma
  • At least 18 years of age.
  • ECOG performance status ≤ 2
  • Adequate hematologic and organ function (unless due to underlying lymphoma per the investigator; see below), defined as follows:
  • Absolute neutrophil count ≥ 1,000/mcL
  • Platelets ≥ 75,000/mcL
  • Hemoglobin ≥ 8 g/dL
  • Serum total bilirubin ≤ 1.5 x IULN (or ≤ 3 x IULN for patients with Gilbert syndrome)
  • AST(SGOT)/ALT(SGPT) ≤ 3 x IULN
  • Serum creatinine ≤ 1.0 x IULN or creatinine clearance ≥ 50 mL/min by Cockcroft-Gault
  • Patients with extensive bone marrow involvement by lymphoma and/or disease-related cytopenias (e.g., immune thrombocytopenia) may be enrolled if the following criteria are met:
  • Absolute neutrophil count ≥ 500/mcL
  • Platelet count ≥ 50,000/mcL without platelet transfusion within 14 days prior to the first dose of mosunetuzumab
  • Hemoglobin ≥ 7 g/dL without red blood cell transfusion within 7 days prior to the first dose of mosunetuzumab
  • The effects of mosunetuzumab on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study treatment, for 3 months following the final dose of mosunetuzumab, for 9 months after the final dose of polatuzumab vedotin, and for 3 months after the final dose of tocilizumab, as applicable. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study treatment, for 6 months after the final dose of polatuzumab vedotin, and for 2 months after the final dose of tocilizumab, as applicable.
  • Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Who cannot join

  • Prior history of aggressive B cell lymphoma such as diffuse large B cell lymphoma or high-grade B cell lymphoma.
  • Known history of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents.
  • Known history of macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH).
  • Current or past history of CNS lymphoma.
  • Any prior systemic therapy for follicular lymphoma.
  • Treatment with radiotherapy within 2 weeks prior to the first dose of mosunetuzumab (otherwise one measurable lesion outside of the radiation field must remain).
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  • Treatment with any anti-CD20 monoclonal antibody within 4 weeks of Day 1 of Cycle 1.
  • Current or recent history (within the last 6 months) of CNS disease, such as stroke, epilepsy CNS vasculitis, or serious progressive neurodegenerative disease, with clinically significant symptoms.
  • 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.
  • Note: The use of inhaled corticosteroids, mineralocorticoids for management of orthostatic hypotension, and single dose dexamethasone for nausea or B symptoms is permitted.
  • History of solid organ transplantation.
  • History of allogeneic stem cell transplantation.
  • Prior treatment with chimeric antigen receptor T cell therapy within 30 days before Day 1 of Cycle 1.
  • History of severe allergic or anaphylactic reaction to humanized, chimeric, or murine monoclonal antibodies (mAbs).
  • Known hypersensitivity to biopharmaceuticals produced in CHO cells or any component of the mosunetuzumab formulation, including mannitol.
  • History of erythema multiforme, Grade ≥ 3 rash, or blistering following prior treatment with immunomodulatory derivatives.
  • Known active bacterial, viral, fungal, or other infection, or any major episode of infection requiring treatment with IV antibiotics within 1 week of Day 1 of Cycle 1.
  • Known or suspected chronic active Epstein-Barr virus (EBV) infection.
  • Current Grade > 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease.
  • Active hepatitis B infection.
  • Patients who are hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (HBcAb) positive, must be negative for hepatitis B virus (HBV) polymerase chain reaction (PCR) to be eligible for study participation
  • Active hepatitis C infection.
  • Patients who are positive for hepatitis C virus (HCV) antibody must be negative for HCV by PCR to be eligible for study participation
  • Known history of human immunodeficiency virus (HIV) positive status.
  • History of progressive multifocal leukoencephalopathy (PML).
  • Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study.
  • Patients must not receive live, attenuated vaccines (e.g., FluMist®) while receiving study treatment or after the last dose until B cell recovery to the normal ranges.
  • Other malignancy that could affect compliance with the protocol or interpretation of results, with the exception of the following:
  • Any of the following malignancies previously curatively treated: carcinoma in situ of the cervix, good-prognosis ductal carcinoma in situ of the breast, basal, or squamous cell skin cancer
  • Stage I melanoma, low grade, early stage localized prostate cancer, or any other previously treated malignancy that has been in remission without treatment for at least 2 years prior to enrollment
  • Active autoimmune disease requiring treatment.
  • History of autoimmune disease, including, but not limited to, myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
  • Patients with a remote history of, or well-controlled autoimmune disease, with a treatment free interval from immunosuppressive therapy for 12 months may be eligible to enroll if judged to be safe by the investigator.
  • Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone are 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, or autoimmune hemolytic anemia may be eligible.
  • Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to, significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm).
  • Major surgical procedure other than for diagnosis within 28 days prior to Day 1 of Cycle 1 Day 1 or anticipation of a major surgical procedure during the course of the study.
  • Pregnant or lactating or intending to become pregnant during the study.
  • Women of childbearing potential must have 1 negative serum pregnancy test result (minimum sensitivity, 25 mIU/mL) within 7 days of initiating Cycle 1 Day 1 of therapy.
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase II Study Evaluating the Efficacy of Mosunetuzumab in Combination With Polatuzumab Vedotin in Untreated Follicular Lymphoma

This phase II clinical trial studies the combination of mosunetuzumab and polatuzumab vedotin in order to see how well it works in patients with untreated follicular lymphoma. Mosunetuzumab is an antibody that has been engineered to attach to two target cells in the immune system: T cells that normally perform tasks like killing virus-infected cells, and cancerous B cells. Mosunetuzumab has been designed to direct these T cells to kill the cancerous B cells instead. Polatuzumab vedotin is an antibody-drug conjugate that attaches to certain cancerous B cells and then delivers a drug specifically to those cells.

Being tested
Mosunetuzumab, Polatuzumab vedotin
Keywords
lymphoma, follicular lymphoma, antibody-drug conjugate, B-NHL, B cell non-Hodgkin lymphoma, mosunetuzumab, polatuzumab vedotin, bispecific antibody
Medical subject headings
Lymphoma, Follicular, Lymphoma, 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, BTCT4465A

    Mosunetuzumab is administered subcutaneously using a "step-up" dosing strategy. The initial dose on C1D1 will be 5 mg, and doses thereafter will be 45 mg.

  • Polatuzumab vedotinDrug

    Also called RO5541077, DCDS4501A

    Polatuzumab vedotin is administered intravenously over 90 minutes for the initial dose, and over 30 minutes thereafter.

Study groups in NCT05410418
Study groupRoleWhat they receive
Mosunetuzumab and Polatuzumab VedotinExperimentalPatients receive CD3xCD20 bispecific antibody mosunetuzumab administered subcutaneously in combination with CD79b directed ADC polatuzumab vedotin administered intravenously. Mosunetuzumab and polatuzumab vedotin are given in combination for 6 cycles. Mosunetuzumab is given on Days 1, 8, and 15 of cycle 1 and then Day 1 thereafter, and polatuzumab vedotin is given on Day 1. After 6 cycles, patients continue on mosunetuzumab alone for 2 additional cycles. Patients undergo scans at the end of cycle 8, and if those scans show a complete response, patients will stop any further treatment and will enter follow-up. Patients with a partial response or stable disease on scans at the end of cycle 8 may receive up to 9 additional cycles of mosunetuzumab in the absence of disease progression or unacceptable toxicity. All cycles are planned to be 21 days.
Receives: Drug: Mosunetuzumab; Drug: Polatuzumab vedotin

What is being measured

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

  1. Number of Participants With Complete Response (CR) as Best Response

    CR determined by response to treatment by PET-CT at end of treatment per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

    Measured: Through completion of treatment (estimated to be 1 year)

Secondary outcomes (27)

  1. Number of Participants With Complete Response (CR)

    CR determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

    Measured: After Cycle 8 (each cycle is 21 days; estimated to be 6 months)

  2. Number of Participants With Partial Response (PR)

    PR determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

    Measured: After Cycle 8 (each cycle is 21 days; estimated to be 6 months)

  3. Number of Participants With Partial Response (PR) as Best Response

    PR determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

    Measured: Through completion of treatment (estimated to be 1 year)

  4. Overall Response Rate (ORR) as Measured by Number of Participants With Complete Response (CR) and Partial Response (PR)

    CR and PR determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

    Measured: After Cycle 8 (each cycle is 21 days; estimated to be 6 months)

  5. Overall Response Rate (ORR) as Measured by Number of Participants With Complete Response (CR) and Partial Response (PR)

    CR and PR determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

    Measured: Through completion of treatment (estimated to be 1 year)

  6. Number of Participants With Stable Disease (SD)

    SD determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

    Measured: After Cycle 8 (each cycle is 21 days; estimated to be 6 months)

  7. Number of Participants With Stable Disease (SD) as Best Response

    SD determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

    Measured: Through completion of treatment (estimated to be 1 year)

  8. Number of Participants With Progressive Disease (PD)

    PD determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

    Measured: After Cycle 8 (each cycle is 21 days; estimated to be 6 months)

  9. Number of Participants With Progressive Disease (PD) as Best Response

    PD determined by response to treatment by PET-CT after Cycle 8 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

    Measured: Through completion of treatment (estimated to be 1 year)

  10. Number of Participants With Complete Response (CR)

    CR determined by response to treatment by PET-CT after Cycle 2 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

    Measured: After Cycle 2 (each cycle is 21 days; estimated to be 42 days)

  11. Number of Participants With Partial Response (PR)

    PR determined by response to treatment by PET-CT after Cycle 2 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

    Measured: After Cycle 2 (each cycle is 21 days; estimated to be 42 days)

  12. Overall Response Rate (ORR) as Measured by Number of Participants With Complete Response (CR) and Partial Response (PR)

    CR and PR determined by response to treatment by PET-CT after Cycle 2 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

    Measured: After Cycle 2 (each cycle is 21 days; estimated to be 42 days)

  13. Number of Participants With Stable Disease (SD)

    SD determined by response to treatment by PET-CT after Cycle 2 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

    Measured: After Cycle 2 (each cycle is 21 days; estimated to be 42 days)

  14. Number of Participants With Progressive Disease (PD)

    PD determined by response to treatment by PET-CT after Cycle 2 per Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT.

    Measured: After Cycle 2 (each cycle is 21 days; estimated to be 42 days)

  15. Time to First Response of Complete Response (CR) or Partial Response (PR)

    Response determined by PET-CT per the Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. Response assessment is performed after cycle 2 (estimated to be day 42), after cycle 8 (estimated to be at 6 months), and at end of treatment (estimated to be 1 year).

    Measured: Through completion of treatment (estimated to be 1 year)

  16. Time to First Complete Response (CR)

    Response determined by PET-CT per the Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. Response assessment is performed after cycle 2 (estimated to be day 42), after cycle 8 (estimated to be at 6 months), and at end of treatment (estimated to be 1 year)

    Measured: Through completion of treatment (estimated to be 1 year)

  17. Frequencies and Grades of Treatment-emergent Adverse Events (TEAEs)

    Measured: Evaluated from start of treatment to 30 day follow-up after conclusion of treatment, study discontinuation/termination, or initiation of alternative lymphoma-directed therapy, whichever occurs first (estimated to be 1 year and 30 days).

  18. Rate of Treatment Discontinuation Due to Treatment-emergent Adverse Events (TEAEs)

    TEAEs are defined as adverse events that are possibly, probably, or definitely related to study treatment and occur on or after first dose of study treatment..

    Measured: Evaluated from start of treatment to 30 day follow-up after conclusion of treatment, study discontinuation/termination, or initiation of alternative lymphoma-directed therapy, whichever occurs first (estimated to be 1 year and 30 days).

  19. Percentage of Patients Requiring Any Tocilizumab Doses for Management of Cytokine Release Syndrome (CRS)

    Tocilizumab is recommended for treatment of grade 2 CRS and required for grade 3 or 4 CRS. Tocilizumab should be administered by IV infusion for a maximum of 4 doses.

    Measured: Up to approximately 1 year and 3 days

  20. Number of Tocilizumab Doses Per Patient for Management of Cytokine Release Syndrome (CRS)

    Tocilizumab is recommended for treatment of grade 2 CRS and required for grade 3 or 4 CRS. Tocilizumab should be administered by IV infusion for a maximum of 4 doses.

    Measured: Up to approximately 1 year and 3 days

  21. Progression-free Survival (PFS)

    Progression-free survival is defined from the time from study enrollment to the first occurrence of disease progression as determined by the investigator with use of the Lugano Response Criteria or death from any cause.

    Measured: At 24 months

  22. Progression-free Survival (PFS)

    Progression-free survival is defined from the time from study enrollment to the first occurrence of disease progression as determined by the investigator with use of the Lugano Response Criteria or death from any cause.

    Measured: At 48 months

  23. Overall Survival (OS)

    Overall survival is defined from the time from study enrollment to death from any cause.

    Measured: At 24 months

  24. Overall Survival (OS)

    Overall survival is defined from the time from study enrollment to death from any cause.

    Measured: At 48 months

  25. Duration of First Response of Complete Response (CR) or Partial Response (PR)

    Response determined by PET-CT per the Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. Response assessment is performed after cycle 2 (estimated to be day 42), after cycle 8 (estimated to be at 6 months), and at end of treatment (estimated to be 1 year)

    Measured: Through completion of follow-up (estimated to be 6 years)

  26. Duration of First Complete Response (CR)

    Response determined by PET-CT per the Deauville 5-point scale (Lugano 2014 criteria). The Deauville scale is scored from 1 to 5, with 1 indicating no uptake on PET-CT and 5 indicating markedly increased uptake on PET-CT. Response assessment is performed after cycle 2 (estimated to be day 42), after cycle 8 (estimated to be at 6 months), and at end of treatment (estimated to be 1 year)

    Measured: Through completion of follow-up (estimated to be 6 years)

  27. Time to Next Treatment (TTNT)

    Time to next treatment (TTNT) initiation is defined as the time from study enrollment to the first documented administration of a new anti-lymphoma treatment (including chemotherapy, radiotherapy, radioimmunotherapy, or immunotherapy) after completion of study treatment.

    Measured: Through completion of follow-up (estimated to be 6 years)

Timeline

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

  1. First posted8 Jun 2022
  2. Study start24 Oct 2022
  3. Primary completion18 Sep 2025
  4. Study completion24 Apr 2029 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05410418
Sponsor's protocol ID
202207147
Status last verified
Oct 2026
First submitted
26 May 2022
Last updated
28 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mosunetuzumab and Polatuzumab vedotin in people with Lymphoma, Follicular and Follicular Lymphoma, run by Washington University School of Medicine 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 24 inclusion and 41 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: under way, not looking for participants, as of the sponsor's last update on 28 Oct 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?

Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Complete Response (CR) as Best Response (time frame: Through completion of treatment (estimated to be 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 NCT05410418.

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 28 Oct 2026.

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