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

Recruiting in Palo Alto (17 mi)

+56 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Genentech, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called Mosunetuzumab, both alone and with another drug called atezolizumab, in patients with blood cancers that have not responded to other treatments. These drugs work by helping the immune system find and destroy cancer cells. Atezolizumab is a medication that has been approved for use in various cancers, including breast cancer, and has shown effectiveness when combined with other treatments.

Eligibility Criteria

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.

Inclusion Criteria

My liver, blood, and kidney functions are all within normal ranges.

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

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

Exclusion Criteria

I haven't taken any immunosuppressive drugs in the last 2 weeks.

I have had a stem cell transplant using my own cells within the last 100 days or any transplant from a donor.

I haven't had radiotherapy in the last 2 weeks before starting Mosunetuzumab.

+8 more

Participant Groups

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.

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.

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for: