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-ES
• 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: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 342

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 FL or 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
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 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 205

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, radioimmunoconjugate or antibody-drug conjugate chemotherapy, or other investigational anti-cancer agent 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