Combination Therapy for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+36 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is an open-label, single arm, multicenter, dose finding, Phase Ib study in order to assess the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) for this combination treatment and to evaluate the general safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and preliminary anti-tumor activity of this combination treatment in adult patients. This study includes an additional open-label imaging feasibility sub-study using a tracer in adult participants with relpased/refractory B-cell non-Hodgkin's lymphoma to image CD8+T-cells at baseline and after treatment with glofitamab, including pre-treatment with obinutuzumab.

Eligibility Criteria

Adults with B-cell Non-Hodgkin's Lymphoma that has come back or didn't respond to treatment, and who have no other life-prolonging therapy options. Participants must have at least one measurable lesion, be in relatively good health (ECOG 0-2), and have proper organ function. They can't join if they've had certain autoimmune diseases, lung conditions, recent cancer treatments, transplants, infections or vaccinations.

Inclusion Criteria

I can take care of myself and am up and about more than half of the day.

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

Negative test results for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV)

+3 more

Exclusion Criteria

I do not have severe nerve damage in my hands or feet.

I have had lung conditions like pulmonary fibrosis or pneumonia, or my CT scan shows active lung inflammation.

I have had a stem cell transplant from a donor.

+18 more

Participant Groups

The trial is testing a combination of drugs including Glofitamab and Atezolizumab or Polatuzumab Vedotin for safety and effectiveness in treating lymphoma. It aims to find the highest dose patients can take without serious side effects (MTD) and suggests a Phase II dose (RP2D). There's also a sub-study using an imaging tracer to see how T-cells are affected by the treatment.

3Treatment groups

Experimental Treatment

Group I: Polatuzumab VedotinExperimental Treatment4 Interventions

Participants will receive Glofitamab in combination with polatuzumab vedotin up to the MTD.

Group II: Imaging Sub-studyExperimental Treatment3 Interventions

Participants will undergo positive-emission tomography/computed tomography (PET/CT) at screening, followed by an "Imaging Cycle," to replace Cycle 1 of the main study. Eligible participants will have the option roll-over to the atezolizumab arm of the main study from Cycle 2 onwards.

Group III: AtezolizumabExperimental Treatment4 Interventions

Participants will receive Glofitamab in combination with Atezolizumab up to the maximum tolerated dose (MTD).

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

🇺🇸 Approved in United States as Tecentriq for: