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Monoclonal Antibodies
RO7227166 + Obinutuzumab + Glofitamab for Non-Hodgkin's Lymphoma
Phase 1
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adverse events from prior anti-cancer therapy must have resolved to Grade </= 1
Must have at least one measureable target lesion (>/= 1.5 cm) in its largest dimension by computed tomography scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part 1: up to 24 months; part ll/lll: up to 18 months
Awards & highlights
Study Summary
This trial is designed to study the safety and effectiveness of RO7227166, given intravenously, in combination with obinutuzumab and glofitamab, for patients with relapsed or refractory non-Hodgkin's lymphoma.
Who is the study for?
This trial is for adults with relapsed/refractory B-Cell Non-Hodgkin's Lymphoma who've had at least two prior treatments and have no other survival-prolonging options. They must not be pregnant or breastfeeding, agree to contraception requirements, have a life expectancy of over 12 weeks, and good organ function. Exclusions include active infections, recent major surgery or immunotherapy, certain cardiovascular diseases, and CNS lymphoma.Check my eligibility
What is being tested?
The study tests RO7227166 combined with obinutuzumab and glofitamab in people with specific lymphomas. It starts with a pre-treatment dose of obinutuzumab followed by the main drugs in escalating doses to find safe levels (Phase I/II) before expanding to more patients (Phase III).See study design
What are the potential side effects?
Potential side effects may include reactions related to infusion such as fever or chills; immune system effects that could cause inflammation in various organs; increased risk of infection; fatigue; allergic reactions; and possible impact on blood counts leading to anemia or bleeding issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Side effects from my previous cancer treatments are mild or gone.
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I have a tumor larger than 1.5 cm detectable by CT scan.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ part 1: up to 24 months; part ll/lll: up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part 1: up to 24 months; part ll/lll: up to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Response (CR)
Disease Control Rate (DCR)
Duration of Response (DOR)
+4 moreSecondary outcome measures
B-cell reduction in blood and tumor tissue
Change from Baseline in Physical Function, Role Function, and HRQoL According to the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Lymphoma Scale
Change from Baseline in Physical Function, Role Function, and Health-Related Quality of Life (HRQoL) Based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
+21 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Part IIIExperimental Treatment4 Interventions
Dose-Expansion Stage: Participants with r/r follicular lymphoma (FL), r/r diffuse large B-cell lymphoma (DLBCL), and r/r MCL will receive RO7227166 administered by IV infusion in combination with glofitamab in a three-weekly schedule (Q3W).
Group II: Part IIExperimental Treatment4 Interventions
Combination Dose-Escalation: Mixed r/r participants and participants with mixed r/r mantle cell lymphoma (MCL) and Richters transformation will receive a fixed dose of obinutuzumab seven days prior to first administration of RO7227166. RO7227166 will be administered by IV infusion in combination with glofitamab in a three-weekly schedule (Q3W).
Group III: Part IExperimental Treatment3 Interventions
Combination Dose-Escalation: Mixed r/r NHL participants will receive a fixed dose of obinutuzumab seven days prior to first administration of RO7227166. RO7227166 will be administered by intravenous (IV) infusion in combination with obinutuzumab in a three-weekly schedule (Q3W).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Glofitamab
2021
Completed Phase 1
~60
Tocilizumab
2012
Completed Phase 4
~1840
Obinutuzumab
2015
Completed Phase 3
~3250
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,089,725 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,442 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had cancer treatment within the last 4 weeks or before the drug's half-life period, whichever is shorter, before starting obinutuzumab.I've had side effects from previous immune treatments or have an autoimmune disease.I have a serious heart condition.I haven't had major surgery or a serious injury in the last 28 days and don't expect to need major surgery soon.I can provide a fresh biopsy from a site that is safe to access, as long as I have more than one measurable lesion.I have or had lymphoma or disease in my brain or spinal cord.Side effects from my previous cancer treatments are mild or gone.I haven't had a live vaccine in the last 4 weeks and don't plan to during the study.I have had a solid organ transplant.My blood tests show high lymphocyte counts or abnormal cells, indicating lymphoma.I am using or willing to use effective birth control or practice complete abstinence during the study.I do not have uncontrolled diseases like diabetes or autoimmune disorders.I don't have an active bacterial, viral, or fungal infection.I have a tumor larger than 1.5 cm detectable by CT scan.My blood cancer has not improved after two treatments and there are no other treatments likely to help me live longer.I am fully active or restricted in physically strenuous activity but can do light work.I agree to use effective birth control during and after treatment as required.I haven't taken strong immune system drugs, except low-dose steroids, in the last 2 weeks.I am not pregnant or breastfeeding and will use effective birth control or am not able to have children.I had a stem cell transplant using my own cells less than 100 days before starting obinutuzumab.I have had severe allergic reactions to antibody treatments and have a confirmed brain infection.I haven't had immunotherapy or similar treatments within the last 4 weeks or five half-lives of the drug before starting obinutuzumab.I have had a stem cell transplant and CAR-T cell therapy before.My liver, blood, and kidney functions are all within normal ranges.I do not have any active infections or recent major infections requiring hospitalization or IV antibiotics.I have not had another type of invasive cancer in the last 2 years.
Research Study Groups:
This trial has the following groups:- Group 1: Part III
- Group 2: Part I
- Group 3: Part II
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently opportunities to participate in this trial?
"Affirmative, the clinical trial is still open for enrollment. It was launched on August 13th 2019 and last updated November 8th 2022; 420 recruits are required from 3 locations."
Answered by AI
How many people have enrolled in this clinical experiment?
"To reach its recruitment efforts, this medical trial needs 420 candidates that are eligible for participation. Potential enrollees can visit either Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center in Denver or Washington University School of Medicine in Saint Louis, Missouri to enter the study."
Answered by AI
Are there other scientific investigations that have been conducted involving RO7227166?
"Currently, 163 clinical studies are being conducted for RO7227166 with 25 trials at Phase 3. Poznan and New york City offer a few of these experiments, yet over 6 thousand other locations also have active research underway."
Answered by AI
What applications are generally ascribed to RO7227166?
"RO7227166 is a commonly used drug to manage cytokine release syndrome associated with car-t cell therapy. It also has proven efficacy in treating conditions like rheumatoid arthritis, lymphoid leukemia, and polyarticular juvenile idiopathic arthritis."
Answered by AI
What potential risks come with the utilization of RO7227166?
"The safety of RO7227166 was evaluated on a scale from 1 to 3 and given an initial assessment of one due the limited clinical data that supports its efficacy and security."
Answered by AI
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