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NCT03645395

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Lenalidomide for the Treatment of Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (MT-3724_NHL_003)

Terminated Phase 2 Results posted Last updated 16 August 2022
What this trial tests

Phase 2 trial testing MT-3724 in Non-hodgkin Lymphoma in 9 participants. Terminated before completion.

Timeline
8 April 2019
Primary endpoint
10 March 2021
10 March 2021

Quick facts

Lead sponsorMolecular Templates, Inc.
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment9
Start date8 April 2019
Primary completion10 March 2021
Estimated completion10 March 2021
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Molecular Templates, Inc. — full company profile →

Who can join

Adults 18 to 101, any sex, with Non-hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity Primary · Up to 1 year

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, o

TEAEs
GroupValue95% CI
Part 1: MT-3724 10 mcg/Kg-LEN3
Part 1: MT-3724 25 mcg/Kg-LEN3
Part 1: MT-3724 20 mcg/Kg-LEN3
SAEs
GroupValue95% CI
Part 1: MT-3724 10 mcg/Kg-LEN1
Part 1: MT-3724 25 mcg/Kg-LEN1
Part 1: MT-3724 20 mcg/Kg-LEN1
DLT
GroupValue95% CI
Part 1: MT-3724 10 mcg/Kg-LEN0
Part 1: MT-3724 25 mcg/Kg-LEN2
Part 1: MT-3724 20 mcg/Kg-LEN0
Part 1 and 2: Number of Participants With Abnormal Laboratory Parameters Primary · Up to 1 year

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.

GroupValue95% CI
Part 1: MT-3724 10 mcg/Kg-LEN3
Part 1: MT-3724 25 mcg/Kg-LEN3
Part 1: MT-3724 20 mcg/Kg-LEN3
Part 1 and 2: Plasma Concentrations of MT-3724 Secondary · Days 1,3 and 12 of treatment cycle (Each cycle is of 28 days); Up to 1 year

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.

GroupValue95% CI
Part 1: MT-3724 10 mcg/Kg-LENNA± NA
Part 1: MT-3724 25 mcg/Kg-LENNA± NA
Part 1: MT-3724 20 mcg/Kg-LENNA± NA
Part 1 and 2: Change From Baseline in B-cell Count Secondary · Up to 1 year

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.

GroupValue95% CI
Part 1: MT-3724 10 mcg/Kg-LENNA± NA
Part 1: MT-3724 25 mcg/Kg-LENNA± NA
Part 1: MT-3724 20 mcg/Kg-LENNA± NA
Part 1 and 2: Number of Participants With Objective Response Rate (ORR) Secondary · Up to 1 year

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 i

PR
GroupValue95% CI
Part 1: MT-3724 10 mcg/Kg-LEN2
Part 1: MT-3724 25 mcg/Kg-LEN0
Part 1: MT-3724 20 mcg/Kg-LEN1
CR
GroupValue95% CI
Part 1: MT-3724 10 mcg/Kg-LEN1
Part 1: MT-3724 25 mcg/Kg-LEN2
Part 1: MT-3724 20 mcg/Kg-LEN1

Adverse events — posted to ClinicalTrials.gov

Time frame: All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: MT-3724 10 mcg/Kg-LEN
Serious: 1/3 (33%)
Deaths: 0/3
Part 1: MT-3724 25 mcg/Kg-LEN
Serious: 1/3 (33%)
Deaths: 0/3
Part 1: MT-3724 20 mcg/Kg-LEN
Serious: 1/3 (33%)
Deaths: 0/3
Part 2: MT-3724 50mcg/Kg-LEN
Serious: 0
Deaths: 0

Serious adverse events (7 terms)

ReactionSystemPart 1: MT-3724 10 mcg/Kg-…Part 1: MT-3724 25 mcg/Kg-…Part 1: MT-3724 20 mcg/Kg-…Part 2: MT-3724 50mcg/Kg-LEN
Atrial fibrillationCardiac disorders
Congestive heart failureCardiac disorders
BacteraemiaInfections and infestations
PneumoniaInfections and infestations
Capillary leak syndromeVascular disorders
NeutropeniaBlood and lymphatic system disorders
AnaemiaBlood and lymphatic system disorders
Other adverse events (57 terms — click to expand)

ReactionSystemPart 1: MT-3724 10 mcg/Kg-…Part 1: MT-3724 25 mcg/Kg-…Part 1: MT-3724 20 mcg/Kg-…Part 2: MT-3724 50mcg/Kg-LEN
MyalgiaMusculoskeletal and connective tissue disorders
Oedema peripheralGeneral disorders
FatigueGeneral disorders
HypokalaemiaMetabolism and nutrition disorders
ConstipationGastrointestinal disorders
HypoalbuminaemiaMetabolism and nutrition disorders
Muscular weaknessMusculoskeletal and connective tissue disorders
ProteinuriaRenal and urinary disorders
PyrexiaGeneral disorders
Chest discomfortGeneral disorders
GlycosuriaRenal and urinary disorders
AnaemiaBlood and lymphatic system disorders
Capillary leak syndromeVascular disorders
DiarrhoeaGastrointestinal disorders
DizzinessNervous system disorders
LeukopeniaBlood and lymphatic system disorders
NauseaGastrointestinal disorders
NeutropeniaBlood and lymphatic system disorders
Oropharyngeal painRespiratory, thoracic and mediastinal disorders
Pain in extremityMusculoskeletal and connective tissue disorders
RashSkin and subcutaneous tissue disorders
Weight increasedInvestigations
Abdominal distensionGastrointestinal disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Aspartate aminotransferase increasedInvestigations
Back painMusculoskeletal and connective tissue disorders
Blood alkaline phosphatase increasedInvestigations
Blood bilirubin increasedInvestigations
CellulitisInfections and infestations
CoughRespiratory, thoracic and mediastinal disorders
Diastolic dysfunctionCardiac disorders
DysphoniaRespiratory, thoracic and mediastinal disorders
DyspneaRespiratory, thoracic and mediastinal disorders
HaematuriaRenal and urinary disorders
HyperglycaemiaMetabolism and nutrition disorders
HypoaesthesiaNervous system disorders
HypocalcaemiaMetabolism and nutrition disorders
HypomagnesaemiaMetabolism and nutrition disorders
HypoproteinaemiaMetabolism and nutrition disorders
HypotensionVascular disorders

Most-reported serious reactions: Atrial fibrillation, Congestive heart failure, Bacteraemia, Pneumonia, Capillary leak syndrome, Neutropenia, Anaemia.

Data from ClinicalTrials.gov NCT03645395 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Antibodies to watch in 2020.
    Kaplon H, Muralidharan M, Schneider Z, Reichert JM. · · 2020 · cited 332× · PMID 31847708 · DOI 10.1080/19420862.2019.1703531
  2. Shiga Toxins as Antitumor Tools.
    Robert A, Wiels J. · · 2021 · cited 21× · PMID 34678982 · DOI 10.3390/toxins13100690
  3. Abstract Book: 25th Congress of the European Hematology Association Virtual Edition, 2020
    · 2020

Verify or expand the search:

Other trials of MT-3724

Trials testing the same drug.

Other recruiting trials for Non-hodgkin Lymphoma

Currently open trials in the same condition.

Other Molecular Templates, Inc. trials

Trials by the same sponsor.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing