A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination with Polatuzumab Vedotin in Patients with B-Cell Non-Hodgkin Lymphoma

Phase 1

• Conditions: B-cell non-Hodgkin lymphoma (NHL); MedDRA version: 24.0Level: LLTClassification code 10067070Term: Follicular B-cell non-Hodgkin's lymphomaSystem Organ Class: 100000004864; MedDRA version: 20.0Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 21.0Level: LLTClassification code 10012820Term: Diffuse large B-cell lymphoma NOSSystem Organ Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code 10012856Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) recurrentSystem Organ Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code 10023768Term: Large cell immunoblastic lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) recurrentSystem Organ Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code 10012857Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractorySystem Organ Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code 10023769Term: Large cell immunoblastic lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractorySystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-001141-13-BE
• Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-25
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 222

Inclusion Criteria

- Age >= 18 years
- Able to comply with the study protocol and procedures in the investigator’s judgment
- Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
- Life expectancy of at least 12 weeks ?
- Patients must have histologically confirmed R/R FL, DLBCL, or MCL
- For DLBCL or FL, must have received at least one prior systemic treatment regimen containing an anti- cluster of differentiation 20 (CD20) - directed therapy
- For MCL, must have received at least two prior systemic treatment regimens which include agents from all three classes below: anti-CD20-directed therapy, a Bruton’s tyrosine kinase (BTK) inhibitor, and an anthracycline or bendamustine
- Adequate hepatic, hematologic and renal function
- Patients who have a negative HIV test at screening, with exceptions to allow HIV positive patients to enroll if certain criteria are met

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 111
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 111

Exclusion Criteria

- Inability to comply with protocol-mandated hospitalization and activity restrictions
- Pregnant or lactating women
- Prior treatment with Mosun or other CD20-directed bispecific antibodies or with Pola
- Current > Grade 1 peripheral neuropathy
- Prior use of any monoclonal antibody, radioimmunoconjugates or antibody-drug conjugates for anti-lymphoma treatment within 4 weeks before first dose of study treatment
- Treatment with radiotherapy within 2 weeks prior to the first dose of study treatment
- Autologous stem-cell transplantation (SCT) within 100 days prior to first study treatment administration, or any prior allogeneic SCT or solid organ transplantation
- Prior treatment with chimeric antigen receptor -T therapy within 30 days before first study treatment administration
- Current or past history of central nervous system (CNS) lymphoma and of CNS disease
- Significant cardiovascular disease or pulmonary disease
- Recent major surgery within 4 weeks prior to first study treatment administration
- Hepatitis B or C or human immunodeficiency virus (HIV)
- Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
- History of autoimmune disease (stable autoimmune diseases may be eligible)
- Systemic immunosuppressive medication within 2 weeks prior to study drug

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified