A Safety, Efficacy and Pharmacokinetic Study of BTCT4465A (Mosunetuzumab) as a Single Agent and Combined With Atezolizumab in Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

Part of paid clinical trials in La Jolla, California.

Sponsor
Genentech, Inc.
Study ID
NCT02500407
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Lymphocytic Leukemia, Chronic
  • Lymphoma, Non Hodgkin

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BTCT4465A (Mosunetuzumab) IV — DRUG
    Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via IV infusion.
  • Atezolizumab — DRUG
    Participants assigned to an atezolizumab combination group will receive atezolizumab 1200 mg administered as an IV infusion in combination with BTCT4465A (Mosunetuzumab).
  • BTCT4465A (Mosunetuzumab) SC — DRUG
    Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via SC injection.

Study Details

This is a Phase 1/2 dose-escalation study of BTCT4465A (Mosunetuzumab) administered as a single agent and in combination with atezolizumab in participants with relapsed or refractory B-cell NHL and CLL. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

Key Dates

First listed
Jul 16, 2015
Start date
Sep 15, 2015
Status verified
Sep 2025
Primary completion
May 21, 2024
Completion
Sep 1, 2025

Study Design

Enrollment
713 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    Participants will receive BTCT4465A (Mosunetuzumab) via intravenous (IV) infusion or subcutaneous (SC) injection as a single-agent or in combination with atezolizumab. Dose escalation will be guided by the observed incidence of DLTs at each dose level.
  • Experimental: Dose Expansion
    Participants will receive BTCT4465A (Mosunetuzumab) as a single-agent or in combination with atezolizumab.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of BTCT4465A (Mosunetuzumab) [ Time Frame: BTCT4465A (Mosunetuzumab) single agent: Cycle 1; BTCT4465A (Mosunetuzumab) in combination with atezolizumab: during the first cycle that BTCT4465A (Mosunetuzumab) and atezolizumab are administered concurrently (cycle length = 21 days) ]

Locations (12)

FacilityCityStateZIPSite coordinators
University of California San Diego Moores Cancer CenterLa JollaCalifornia92093-0698-
Sansum Medical Clinic, Inc.Santa BarbaraCalifornia93105-
Rocky Mountain Cancer CenterDenverColorado80218-
Yale University School Of MedicineNew HavenConnecticut06510-
Hackensack University Medical CenterHackensackNew Jersey07601-
Memorial Sloan Kettering BergenMontvaleNew Jersey07645-
Memorial Sloan Kettering Cancer Center - CommackCommackNew York11725-
Memorial Sloan Kettering Cancer Center at WestchesterHarrisonNew York10604-
New York Uni Medical CenterNew YorkNew York10016-
Willamette Valley Cancer Insitute and Research CenterSpringfieldOregon97477-
University of PennsylvaniaPhiladelphiaPennsylvania19103-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in La Jolla, CA

By research site
University of California San Diego Moores Cancer Center· La Jolla, CASansum Medical Clinic, Inc.· Santa Barbara, CARocky Mountain Cancer Center· Denver, COYale University School Of Medicine· New Haven, CTHackensack University Medical Center· Hackensack, NJMemorial Sloan Kettering Bergen· Montvale, NJ

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