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Checkpoint Inhibitor

Atezolizumab + BTCT4465A (Mosunetuzumab) for Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

Phase 1 & 2

Waitlist Available

Research Sponsored by Genentech, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

B-cell hematologic malignancies expected to express the cluster of differentiation 20 (CD20) antigen who have relapsed after or failed to respond to at least one prior treatment regimen and for whom there is no available therapy expected to improve survival

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline until death from any cause (up to approximately 4 years)

Awards & highlights

Study Summary

This trial is testing a new cancer drug, BTCT4465A (Mosunetuzumab), given alone or with another drug, atezolizumab. It is for people with B-cell Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia that has come back or does not respond to treatment.

Who is the study for?

This trial is for adults with B-cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia who have tried at least one treatment that didn't work. They should be in fairly good health otherwise, not pregnant, and haven't had certain treatments like stem cell transplants recently.Check my eligibility

What is being tested?

Researchers are testing Mosunetuzumab, given by injection or IV, alone and combined with Atezolizumab to see how safe and effective they are against these blood cancers. The study has two parts: finding the right dose and then seeing how well it works in specific groups.See study design

What are the potential side effects?

Possible side effects include reactions where the drug enters the body, tiredness, changes in blood tests (like liver function), increased risk of infections due to a weakened immune system, and possibly others as this is an early-phase trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My B-cell cancer has not improved after at least one treatment and no other treatments are likely to help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline until death from any cause (up to approximately 4 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline until death from any cause (up to approximately 4 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline until death from any cause (up to approximately 4 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Atezolizumab Serum Concentration

BTCT4465A (Mosunetuzumab) Serum Concentration

Maximum Tolerated Dose (MTD) of BTCT4465A (Mosunetuzumab)

+2 more

Secondary outcome measures

Duration of Response as Assessed Using Standard Criteria for NHL

European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Scores to Assess Health-Related Quality of Life (HRQoL)

Objective Response Rate (ORR)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment3 Interventions

Participants will receive BTCT4465A (Mosunetuzumab) as a single-agent or in combination with atezolizumab.

Group II: Dose EscalationExperimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor

1,539 Previous Clinical Trials

566,919 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

887,732 Total Patients Enrolled

Media Library

Chronic Lymphocytic Leukemia Research Study Groups: Dose Escalation, Dose Expansion

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical centers have been enlisted to participate in this research?

"Memorial Sloan-Kettering Cancer Center in Commack, City of Hope National Medical Center in Duarte, and Hackensack University Medical Center in Hackensack are amongst the twenty recruitment sites for this clinical trial. Additionally there are an additional 17 locations where potential participants can apply."

Answered by AI

For what medical conditions is Mosunetuzumab SC typically prescribed?

"BTCT4465A (Mosunetuzumab) SC is a viable solution for the treatment of small cell lung cancer, malignant neoplasms and non-small cell lung carcinoma."

Answered by AI

Is participation in this research endeavor still being accepted?

"Affirmative. Clinicaltrials.gov documents confirm that this medical research is presently enrolling participants, having been initially published on September 15th 2015 and revised November 30th 2022. This clinical trial aims to enlist 836 patients from 20 locations across the country."

Answered by AI

Have there been any other experiments utilizing Mosunetuzumab delivered via subcutaneous injection?

"Mosunetuzumab, or BTCT4465A SC, was first investigated in 2008 at the Tennessee Oncology Chattanooga. A total of 81 trials have been concluded since then and 362 more are ongoing presently; a considerable portion of these experiments taking place in Commack, New york."

Answered by AI

Does this experiment break new ground in the field of medicine?

"Since 2008, research concerning BTCT4465A (Mosunetuzumab) SC has progressed steadily. First tested in a 720-person trial sponsored by Hoffmann-La Roche, the drug achieved Phase 2 approval and is now being studied in 362 active trials across 1653 cities and 75 countries."

Answered by AI

Could you provide a tally of the total participants in this trial?

"This trial requires 836 participants, who meet the necessary requirements to partake. Potential enrollees may join from Memorial Sloan-Kettering Cancer Center in Commack, New york and City of Hope National Medical Center in Duarte, California - among other locations."

Answered by AI