A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma

Conditions

• B-cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Mosunetuzumab (IV) — DRUG
  Participants will receive intravenous (IV) mosunetuzumab.
• Mosunetuzumab (SC) — DRUG
  Participants will receive subcutaneous (SC) mosunetuzumab.
• Polatuzumab vedotin — DRUG
  Participants will receive IV polatuzumab vedotin.
• Tocilizumab — DRUG
  Participants will receive IV tocilizumab as needed.
• Rituximab — DRUG
  Participants will receive IV rituximab.

Study Details

This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of intravenous (IV) or subcutaneous (SC) mosunetuzumab in combination with polatuzumab vedotin in participants with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). It will consist of a dose finding portion followed by an expansion phase for second line or later (2L+) participants with relapsed or refractory (R/R) DLBCL and 2L+ R/R FL. In addition, subcutaneous mosunetuzumab in combination with polatuzumab vedotin will be evaluated in participants with at least 2 prior lines of systemic therapy (3L+) for the treatment of R/R mantle cell lymphoma (MCL) and in participants with 2L+ R/R DLBCL.

Key Dates

Start date

Sep 25, 2018

Status verified

Nov 2024

Primary completion

Jan 30, 2024

Completion

Jul 20, 2025

Study Design

Enrollment

422 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Dose Finding
  Participants will receive mosunetuzumab in combination with polatuzumab vedotin. Dose finding will be guided by the observed incidence of dose-limiting toxicities (DLTs) at each dose level.
• Experimental: Mosunetuzumab + Polatuzumab Vedotin 2L+ R/R FL
  Participants with at least one line of prior therapy (2L+) and that have relapsed or refractory (R/R) follicular lymphoma (FL) will receive mosunetuzumab + polatuzumab vedotin.
• Experimental: Mosunetuzumab + Polatuzumab Vedotin 2L+R/R DLBCL
  2L+ participants with R/R diffuse large B-cell lymphoma will receive mosunetuzumab + polatuzumab vedotin.
• Experimental: Mosunetuzumab SC + Polatuzumab Vedotin 3L+R/R MCL
  Participants with at least 2 lines of prior therapy (3L+) will receive subcutaneous (SC) mosunetuzumab + polatuzumab vedotin.
• Experimental: Mosunetuzumab SC + Polatuzumab Vedotin 2L+R/R DLBCL
  2L+ participants with R/R DLBCL will receive SC mosunetuzumab and polatuzumab vedotin.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Mosunetuzumab in Combination with Polatuzumab Vedotin [ Time Frame: Cycle 1 to Cycle 2 (cycle length = 21 days) ]

Locations (16)

Find similar trials in Birmingham, AL

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