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OncoMatch/Clinical Trials/NCT06453044

Mosunetuzumab and Polatuzumab Vedotin for the Treatment of Patients With Relapsed or Refractory Grade 1-3a Follicular Lymphoma

Is NCT06453044 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Mosunetuzumab and Polatuzumab Vedotin for recurrent grade 1 follicular lymphoma.

Phase 2RecruitingCity of Hope Medical CenterNCT06453044Data as of May 2026

Treatment: Mosunetuzumab · Polatuzumab VedotinThis phase II trial tests how well mosunetuzumab and polatuzumab vedotin works in treating patients with grade 1-3a follicular lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Giving mosunetuzumab and polatuzumab vedotin may kill more cancer cells in patients with relapsed or refractory grade 1-3a follicular lymphoma.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Biomarker criteria

Required: CD20 positive by immunohistochemistry or flow cytometry after the most recent therapy (positive)

Tumor must be positive for CD20 by immunohistochemistry or flow cytometry after the most recent therapy.

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: anti-cancer therapy

Relapsed/ refractory disease after at least one prior line of therapy. Relapse must have been confirmed histologically

Cannot have received: CD20-directed bispecific antibody (mosunetuzumab)

Exception: Prior exposure to 2 or less doses without evidence of resistance is allowed

Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies. Prior exposure to 2 or less doses without evidence of resistance is allowed

Cannot have received: antibody-drug conjugate containing monomethyl auristatin E (MMAE) (polatuzumab vedotin)

Exception: Prior exposure to 2 or less doses without evidence of resistance is allowed

Prior treatment with polatuzumab vedotin or with an antibody-drug conjugate containing monomethyl auristatin E (MMAE). Prior exposure to 2 or less doses without evidence of resistance is allowed

Cannot have received: allogeneic stem cell transplant

Exception: Allowed if >2 years prior to protocol therapy and stable off immunosuppressive agents for ≥ 2 months

Allogeneic stem cell transplant within 2 years prior to day 1 of protocol therapy, requires immunosuppression, or has evidence of active-versus-host-disease

Cannot have received: autologous stem cell transplant

Autologous stem cell transplant within 100 days prior to day 1 of protocol therapy

Cannot have received: CAR-T cell therapy

Chimeric antigen receptor (CAR)-T therapy within 30 days prior to day 1 of protocol therapy

Cannot have received: monoclonal antibody, radioimmunoconjugate or antineoplastic drug conjugate (ADC)

Prior use of any anti-lymphoma treatment with monoclonal antibody, radioimmunoconjugate or antineoplastic drug conjugate (ADC) within 4 weeks prior to day 1 of protocol therapy

Cannot have received: chemotherapeutic agent or other anti-cancer agent (investigational or otherwise)

Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to day 1 of protocol therapy

Cannot have received: radiotherapy

Exception: If patients have received radiotherapy within 4 weeks prior to day 1 of protocol therapy, 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.

Treatment with radiotherapy within 2 weeks prior to day 1 of protocol therapy

Lab requirements

Blood counts

WITHOUT BONE MARROW INVOLVEMENT: ANC ≥ 1,000/mm^3, platelets ≥ 75,000/mm^3; WITH BONE MARROW INVOLVEMENT: ANC ≥ 500/mm^3, platelets ≥ 50,000/mm^3; Hemoglobin ≥ 8 g/dL

Kidney function

Creatinine clearance of ≥ 40 mL/min per 24 hour urine test or Cockcroft-Gault formula

Liver function

Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN if hepatic involvement by lymphoma or Gilbert's disease); AST/ALT ≤ 2.5 x ULN (≤ 5 x ULN if hepatic involvement by lymphoma)

WITHOUT BONE MARROW INVOLVEMENT BY LYMPHOMA: ANC ≥ 1,000/mm^3; Platelets ≥ 75,000/mm^3. WITH BONE MARROW INVOLVEMENT BY LYMPHOMA AND/OR DISEASE-RELATED NEUTROPENIAS: ANC ≥ 500/mm^3; Platelets ≥ 50,000/mm^3. Hemoglobin ≥ 8 g/dL. Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN if hepatic involvement by lymphoma or Gilbert's disease); AST/ALT ≤ 2.5 x ULN (≤ 5 x ULN if hepatic involvement by lymphoma); Creatinine clearance of ≥ 40 mL/min per 24 hour urine test or Cockcroft-Gault formula

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope Medical Center · Duarte, California
  • City of Hope Orange County Lennar Foundation Cancer Center · Irvine, California

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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