Your session is about to expire
← Back to Search
CAR T-cell Therapy
MB-106 for Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia
Phase 1 & 2
Recruiting
Research Sponsored by Mustang Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For Phase 2: Patient must meet specific criteria for each arm including relapsed or refractory DLBCL, FL, CLL/SLL, and B-cell NHL subtypes that have progressed after available therapies. Patients treated with prior CD19-directed CAR-T therapy must meet additional criteria such as relapse duration and CD19+ B-cell count. Patients with NHL must have at least 1 measurable lesion according to the revised International Working Group Response Criteria for Malignant Lymphoma. Patients with CLL must have a diagnosis that meets published diagnostic criteria and evidence of CD20 expression on tumor specimen. Patients must also meet specific laboratory criteria, be ≥18 years old, have ECOG performance status of 0 or 1, and a life expectancy of ≥ 16 weeks.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing a new drug, MB-106, for safety and effectiveness in people with relapsed or refractory B-cell NHL or CLL.
Who is the study for?
Adults over 18 with relapsed or refractory B-Cell Non-Hodgkin's Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL), who have tried standard treatments without success. Participants must be expected to live at least 16 weeks, not be pregnant, use effective contraception, and have adequate organ function. Those with certain other health conditions or recent treatments are excluded.Check my eligibility
What is being tested?
The trial is testing MB-106 for safety and effectiveness in patients whose B-cell NHL or CLL has returned after treatment. It includes different phases for various subtypes of these cancers, assessing how well the intervention works after previous therapies like chemotherapy and CAR-T cell therapy.See study design
What are the potential side effects?
While specific side effects of MB-106 aren't listed here, similar therapies often cause immune reactions, fatigue, infusion-related symptoms, blood count changes, risk of infections and may affect organ functions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Primary objective
Phase 2: Primary objective
Secondary outcome measures
Phase 1: Secondary objective
Phase 2: Secondary objective
Trial Design
7Treatment groups
Experimental Treatment
Group I: Phase 2: Relapsed or refractory FLExperimental Treatment1 Intervention
MB-106, single intravenous infusion. Dose based upon outcome Phase 1.
Group II: Phase 2: Relapsed or refractory CLL/SLLExperimental Treatment1 Intervention
MB-106, single intravenous infusion. Dose based upon outcome Phase 1.
Group III: Phase 2: Patients with relapsed or refractory DLBCLExperimental Treatment1 Intervention
MB-106, single intravenous infusion. Dose based upon outcome Phase 1.
Group IV: Phase 2: Basket - Relapsed or refractory B-cell NHL subtypesExperimental Treatment1 Intervention
MB-106, single intravenous infusion. Dose based upon outcome Phase 1.
Group V: Phase 1: Patients with indolent NHL including, but not limited to, FL.Experimental Treatment1 Intervention
MB-106, single intravenous infusion up to 3.3 x 10e7 CAR-T cells/kg
Group VI: Phase 1: Patients with aggressive B-cell NHL including, but not limited to, DLBCL and MCL.Experimental Treatment1 Intervention
MB-106, single intravenous infusion up to 3.3 x 10e7 chimeric antigen receptor t-cells (CAR-T cells)/kg
Group VII: Phase 1: Patients with CLL/small lymphocytic lymphoma (SLL).Experimental Treatment1 Intervention
MB-106, single intravenous infusion up to 3.3 x 10e7 CAR-T cells/kg
Find a Location
Who is running the clinical trial?
Mustang BioLead Sponsor
3 Previous Clinical Trials
384 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,721 Previous Clinical Trials
40,964,767 Total Patients Enrolled
Mazyar Shadman, MDStudy ChairFred Hutchinson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My B-cell NHL or CLL has not improved after standard treatments, including a stem cell transplant or CAR-T therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2: Relapsed or refractory FL
- Group 2: Phase 2: Relapsed or refractory CLL/SLL
- Group 3: Phase 2: Basket - Relapsed or refractory B-cell NHL subtypes
- Group 4: Phase 1: Patients with aggressive B-cell NHL including, but not limited to, DLBCL and MCL.
- Group 5: Phase 1: Patients with indolent NHL including, but not limited to, FL.
- Group 6: Phase 1: Patients with CLL/small lymphocytic lymphoma (SLL).
- Group 7: Phase 2: Patients with relapsed or refractory DLBCL
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.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Share this study with friends
Copy Link
Messenger