The purpose of this study is to evaluate the safety and tolerability of MT-3724 in combination with Lenalidomide in participants with relapsed or refractory B-Cell NHL.
This is a multi-center, open-label two-part study evaluating the safety and tolerability of MT-3724 in combination with Lenalidomide in relapsed or refractory CD20 positive B-cell Lymphoma participants. Part 1: (MT-3724 Dose Escalation) Define the maximum tolerated dose (MTD) of MT-3724 in combination with standard treatment of Lenalidomide Part 2: (MTD Expansion Cohort) Confirm the safety and tolerability of the MTD of MT-3724 from Part 1 in the MTD Expansion Cohort, where MT-3724 will be given at the MTD in combination with Lenalidomide. In addition, the Pharmacokinetics (PK), Pharmacodynamics (PD), immunogenicity and tumor response at the MTD of MT-3724 in combination with Lenalidomide will be more thoroughly evaluated in Part 2. It is anticipated that up to 64 participants will be enrolled. Treatment will continue until disease progression, withdrawal of consent or any other reason.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Experimental treatment with MT-3724 in combination with LEN therapy.
Innovative Clinical Research Institute
Whittier, California, United States
Boca Raton Clinical Research
Plantation, Florida, United States
Rush University
Chicago, Illinois, United States
University of Maryland
Baltimore, Maryland, United States
Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity
An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention. A DLT is any TEAE that occurred after the start of infusion in cycle 1 of Part 1 and the TEAE is at least possibly related to the study drug, as determined by the sponsor after consultation with the investigator(s).
Time frame: Up to 1 year
Part 1 and 2: Number of Participants With Abnormal Laboratory Parameters
Laboratory parameters included hematology, blood chemistry, and urinalysis. Any abnormal laboratory test results which were considered clinically significant by the investigator were recorded on the case report form. Number of participants with any clinically significant abnormalities in laboratory parameters have been presented.
Time frame: Up to 1 year
Part 1 and 2: Number of Participants With Clinically Significant Physical Findings
This analysis was planned but data was not captured in the database. Abnormal changes were captured as adverse events if they were clinically significant.
Time frame: Up to 1 year
Part 1 and 2: Plasma Concentrations of MT-3724
Blood samples were collected for Pharmacokinetic (PK) analysis of MT-3724. Data could not be calculated due to small sample size and inconsistent sampling as a result of early termination.
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University of Texas Southwestern
Dallas, Texas, United States
Time frame: Days 1,3 and 12 of treatment cycle (Each cycle is of 28 days); Up to 1 year
Part 1 and 2: Change From Baseline in B-cell Count
Blood samples were collected for analysis of B-cell count. Data could not be calculated due to small sample size and inconsistent sampling as a result of early termination.
Time frame: Up to 1 year
Part 1 and 2: Number of Participants With Anti-drug Antibody Titer When Treated With MT-3724
Blood samples were collected for analysis of ADA titer. Data was not collected due to early termination of the trial.
Time frame: Up to 1 year
Part 1 and 2: Number of Participants With Neutralizing Antibody (NAb) Titers When Treated With MT-3724
Blood samples were planed to be collected for analysis of neutralizing antibody (NAb) titers. Data was not collected due to early termination of the trial.
Time frame: Up to 1 year
Part 1 and 2: Number of Participants With Objective Response Rate (ORR)
ORR was defined as CR or Partial Response (PR). CR: a score 1 (no uptake above background), 2 (uptake \<=mediastinum), or 3 (\<mediastinum but \<=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PR: a score 4 (uptake moderately greater than \[\>\] liver) or 5 (uptake markedly \>liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Higher score indicates worse outcomes.
Time frame: Up to 1 year
Part 1 and 2: Duration of Response (DOR)
DOR is defined as the time from the first documented complete or partial response to the actual date of disease progression or death before progression. Data was not collected due to early termination of the trial.
Time frame: Up to 1 year
Part 1 and 2: Progression Free Survival (PFS)
PFS is defined as the time from first dose date until the first occurrence of documented disease progression or death from any cause in the absence of progressive disease. Data was not collected due to early termination of the trial.
Time frame: Up to 1 year
Part 1 and 2: Overall Survival (OS)
OS is defined as the time from date of start of treatment to date of death due to any cause. Data was not collected due to early termination of the trial.
Time frame: Up to 1 year