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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 below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

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

0 / 1Eligibility criteria met

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

13,660 Previous Clinical Trials

40,924,047 Total Patients Enrolled

Mazyar Shadman, MDStudy ChairFred Hutchinson Cancer Center

Media Library

MB-106 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05360238 — Phase 1 & 2

$Mantle Cell Lymphoma Research Study Groups: Phase 2: Relapsed or refractory FL, Phase 2: Relapsed or refractory CLL/SLL, Phase 2: Basket - Relapsed or refractory B-cell NHL subtypes, Phase 1: Patients with aggressive B-cell NHL including, but not limited to, DLBCL and MCL., Phase 1: Patients with indolent NHL including, but not limited to, FL., Phase 1: Patients with CLL/small lymphocytic lymphoma (SLL)., Phase 2: Patients with relapsed or refractory DLBCL$

MB-106 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05360238 — Phase 1 & 2

Mantle Cell Lymphoma Clinical Trial 2023: MB-106 Highlights & Side Effects. Trial Name: NCT05360238 — Phase 1 & 2

Frequently Asked Questions

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

How many participants are presently enrolled in this clinical experiment?

"Affirmative. Clinicaltrials.gov's information reveals that the trial, which was published on May 24th 2022, is actively searching for participants. At least 287 people are needed from 4 distinct medical facilities."

Answered by AI

How many medical centers are currently conducting this research?

"The research team at Massachusetts General Hospital (MGH), UC Irvine Health - Chao Family Comprehensive Cancer Center and Fred Hutchinson Cancer Research Centre are leading this clinical trial, with additional sites located across the United States."

Answered by AI

Are there still vacancies available in this research project?

"As per the records on clinicaltrials.gov, this research project is actively looking for volunteers to take part. The trial has been posted since May 24th 2022 and recently updated in early November of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Assess Safety, Tolerability and Efficacy of MB-106 in Patients With Relapsed or Refractory B-Cell NHL or CLL

2022. "Study to Assess Safety, Tolerability and Efficacy of MB-106 in Patients With Relapsed or Refractory B-Cell NHL or CLL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05360238.

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