Study on Mosunetuzumab and Polatuzumab Vedotin for Treating Relapsed or Hard-to-Treat Follicular Lymphoma

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06453044

Provider View

This clinical trial is exploring the effectiveness of two drugs, mosunetuzumab and polatuzumab vedotin, in treating patients with follicular lymphoma that has returned or not responded to previous treatments. These drugs work by targeting and killing cancer cells.

Patient Parameters

Program Overview

This phase II study is testing how well the combination of mosunetuzumab and polatuzumab vedotin works in patients with follicular lymphoma that has either come back after treatment or hasn't responded to previous treatments. Mosunetuzumab is a type of drug that may stop cancer cells from growing and spreading. Polatuzumab vedotin is a drug that targets specific cancer cells and delivers a toxic substance to kill them. The aim is to see if these drugs can kill more cancer cells in patients with this type of lymphoma.

Description

The main goals of this study are to see if the combination of mosunetuzumab and polatuzumab vedotin is safe and to estimate how many patients achieve a complete response, meaning no signs of cancer, after treatment. The study will also look at how long patients respond to the treatment, how long they live without the disease getting worse, and their overall survival and quality of life.

Patients will receive polatuzumab vedotin through an IV on the first day of each treatment cycle, which repeats every 21 days for up to 6 cycles, as long as the disease doesn't progress or cause unacceptable side effects. Mosunetuzumab will be given under the skin on specific days of the first cycle and then on the first day of the remaining cycles, repeating every 21 days for up to 8-17 cycles.

Throughout the study, patients will have blood tests and imaging scans like CT, PET/CT, or MRI to monitor their progress. After finishing the treatment, patients will have follow-up visits at 30 days and then for 3 years.

Eligibility Criteria

Inclusion Criteria

  • Must provide informed consent to participate.
  • Willing to provide a tumor sample before starting the study.
  • Age 18 or older.
  • Good overall health with an ECOG score of 0 to 2.
  • Diagnosed with grade 1-3a follicular lymphoma.
  • The lymphoma must have returned or not responded after at least one previous treatment.
  • Cancer cells must have the CD20 marker.
  • Active disease that needs treatment.
  • Measurable disease by imaging criteria.
  • Adequate blood cell counts and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after the study.
  • Men must agree to use condoms or abstain from intercourse during and after the study.

Exclusion Criteria

  • Previous treatment with mosunetuzumab or similar drugs.
  • Recent stem cell transplant or CAR-T therapy.
  • Recent treatment with other anti-cancer drugs or radiation.
  • Recent live vaccine.
  • Ongoing use of certain immunosuppressive medications.
  • Severe allergic reactions to similar drugs.
  • History of certain lung diseases or infections.
  • Active infections or uncontrolled illnesses.
  • Active hepatitis B, C, or HIV infections.
  • Active central nervous system involvement by lymphoma.
  • Recent major surgery or other primary cancers not in remission.
  • Pregnant or breastfeeding women.
  • Any condition that might interfere with the study.

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