Trial · 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)
NCT03645395, Phase 2, Terminated, Molecular Templates, Inc.; results first posted 2022-08-16
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. 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). Trials, record NCT03645395. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03645395
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT03645395
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Molecular Templates, Inc.
- Conditions
- Non-hodgkin Lymphoma
- Interventions
- MT-3724
- First posted
- 2018-08-24
- Last updated
- 2022-08-16
- Results first posted
- 2022-08-16
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity | 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, 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). |
| Primary | Part 1 and 2: Number of Participants With Abnormal Laboratory Parameters | 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. |
| Primary | Part 1 and 2: Number of Participants With Clinically Significant Physical Findings | Up to 1 year | This analysis was planned but data was not captured in the database. Abnormal changes were captured as adverse events if they were clinically significant. |
| Secondary | Part 1 and 2: Plasma Concentrations of MT-3724 | 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. |
| Secondary | Part 1 and 2: Change From Baseline in B-cell Count | 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. |
| Secondary | Part 1 and 2: Number of Participants With Anti-drug Antibody Titer When Treated With MT-3724 | Up to 1 year | Blood samples were collected for analysis of ADA titer. Data was not collected due to early termination of the trial. |
| Secondary | Part 1 and 2: Number of Participants With Neutralizing Antibody (NAb) Titers When Treated With MT-3724 | Up to 1 year | 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. |
| Secondary | Part 1 and 2: Number of Participants With Objective Response Rate (ORR) | 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 in bone marrow compared with baseline. Higher score indicates worse outcomes. |
| Secondary | Part 1 and 2: Duration of Response (DOR) | Up to 1 year | 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. |
| Secondary | Part 1 and 2: Progression Free Survival (PFS) | Up to 1 year | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity | Up to 1 year | Safety Population included participants who received at least one dose of any study drug (either MT-3724, or lenalidomide). Part 2 was not initiated due to Sponsor's decision to terminate the trial. | participants | NUMBER |
| PRIMARY | Part 1 and 2: Number of Participants With Abnormal Laboratory Parameters | Up to 1 year | Safety Population. Part 2 was not initiated due to Sponsor's decision to terminate the trial. | Participants | NUMBER |
| PRIMARY | Part 1 and 2: Number of Participants With Clinically Significant Physical Findings | Up to 1 year | Safety population. Part 2 was not initiated due to Sponsor's decision to terminate the trial. | ||
| SECONDARY | Part 1 and 2: Plasma Concentrations of MT-3724 | Days 1,3 and 12 of treatment cycle (Each cycle is of 28 days); Up to 1 year | PK population included all participants who received at least one dose of MT-3724 and have at least one post-baseline PK assessment. Part 2 was not initiated due to Sponsor's decision to terminate the trial. | Micrograms per milliliter | MEAN |
| SECONDARY | Part 1 and 2: Change From Baseline in B-cell Count | Up to 1 year | Pharmacodynamic (PD) Population included all participants who received at least one dose of MT-3724 and have at least one post-baseline PD assessment. Part 2 was not initiated due to Sponsor's decision to terminate the trial. | Giga cells per liter | MEAN |
| SECONDARY | Part 1 and 2: Number of Participants With Anti-drug Antibody Titer When Treated With MT-3724 | Up to 1 year | Immunogenicity Population included all participants who received at least one dose of MT-3724 and have at least one post-baseline immunogenicity assessment. Part 2 was not initiated due to Sponsor's decision to terminate the trial. | ||
| SECONDARY | Part 1 and 2: Number of Participants With Neutralizing Antibody (NAb) Titers When Treated With MT-3724 | Up to 1 year | Immunogenicity Population included all participants who received at least one dose of MT-3724 and have at least one post-baseline immunogenicity assessment. Part 2 was not initiated due to Sponsor's decision to terminate the trial. | ||
| SECONDARY | Part 1 and 2: Number of Participants With Objective Response Rate (ORR) | Up to 1 year | Safety population. Part 2 was not initiated due to Sponsor's decision to terminate the trial. The rows presenting data for PR and CR are mutually exclusive. | participants | NUMBER |
| SECONDARY | Part 1 and 2: Duration of Response (DOR) | Up to 1 year | Safety population. Part 2 was not initiated due to Sponsor's decision to terminate the trial. | ||
| SECONDARY | Part 1 and 2: Progression Free Survival (PFS) | Up to 1 year | Safety population. Part 2 was not initiated due to Sponsor's decision to terminate the trial. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity | Part 1: MT-3724 10 mcg/Kg-LEN | TEAEs | 3 | participants | |
| Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity | Part 1: MT-3724 25 mcg/Kg-LEN | TEAEs | 3 | participants | |
| Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity | Part 1: MT-3724 20 mcg/Kg-LEN | TEAEs | 3 | participants | |
| Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity | Part 1: MT-3724 10 mcg/Kg-LEN | SAEs | 1 | participants | |
| Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity | Part 1: MT-3724 25 mcg/Kg-LEN | SAEs | 1 | participants | |
| Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity | Part 1: MT-3724 20 mcg/Kg-LEN | SAEs | 1 | participants | |
| Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity | Part 1: MT-3724 10 mcg/Kg-LEN | DLT | 0 | participants | |
| Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity | Part 1: MT-3724 25 mcg/Kg-LEN | DLT | 2 | participants | |
| Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity | Part 1: MT-3724 20 mcg/Kg-LEN | DLT | 0 | participants | |
| Part 1 and 2: Number of Participants With Abnormal Laboratory Parameters | Part 1: MT-3724 10 mcg/Kg-LEN | 3 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 (Up to 6 Months) | STARTED | Part 1: MT-3724 10 mcg/Kg-LEN | 3 | |
| Part 1 (Up to 6 Months) | STARTED | Part 1: MT-3724 25 mcg/Kg-LEN | 3 | |
| Part 1 (Up to 6 Months) | STARTED | Part 1: MT-3724 20 mcg/Kg-LEN | 3 | |
| Part 1 (Up to 6 Months) | STARTED | Part 2: MT-3724 50mcg/Kg-LEN | 0 | |
| Part 1 (Up to 6 Months) | COMPLETED | Part 1: MT-3724 10 mcg/Kg-LEN | 1 | |
| Part 1 (Up to 6 Months) | COMPLETED | Part 1: MT-3724 25 mcg/Kg-LEN | 0 | |
| Part 1 (Up to 6 Months) | COMPLETED | Part 1: MT-3724 20 mcg/Kg-LEN | 0 | |
| Part 1 (Up to 6 Months) | COMPLETED | Part 2: MT-3724 50mcg/Kg-LEN | 0 | |
| Part 1 (Up to 6 Months) | NOT COMPLETED | Part 1: MT-3724 10 mcg/Kg-LEN | 2 | |
| Part 1 (Up to 6 Months) | NOT COMPLETED | Part 1: MT-3724 25 mcg/Kg-LEN | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events256
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fatigue | General disorders | Part 1: MT-3724 10 mcg/Kg-LEN | 1 | 3 | |
| other | Fatigue | General disorders | Part 1: MT-3724 25 mcg/Kg-LEN | 2 | 3 | |
| other | Fatigue | General disorders | Part 1: MT-3724 20 mcg/Kg-LEN | 2 | 3 | |
| other | Fatigue | General disorders | Part 2: MT-3724 50mcg/Kg-LEN | 0 | 0 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Part 1: MT-3724 10 mcg/Kg-LEN | 2 | 3 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Part 1: MT-3724 25 mcg/Kg-LEN | 1 | 3 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Part 1: MT-3724 20 mcg/Kg-LEN | 2 | 3 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Part 2: MT-3724 50mcg/Kg-LEN | 0 | 0 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Part 1: MT-3724 10 mcg/Kg-LEN | 0 | 3 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Part 1: MT-3724 25 mcg/Kg-LEN | 3 | 3 |
1 to 10 of 256Source ClinicalTrials.gov
See all 256 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: MT-3724 10 mcg/Kg-LEN | 0 | 3 |
| Total, all-cause mortality | Part 1: MT-3724 25 mcg/Kg-LEN | 0 | 3 |
| Total, all-cause mortality | Part 1: MT-3724 20 mcg/Kg-LEN | 0 | 3 |
| Total, all-cause mortality | Part 2: MT-3724 50mcg/Kg-LEN | 0 | 0 |
| Total, other adverse events | Part 1: MT-3724 10 mcg/Kg-LEN | 3 | 3 |
| Total, other adverse events | Part 1: MT-3724 25 mcg/Kg-LEN | 3 | 3 |
| Total, other adverse events | Part 1: MT-3724 20 mcg/Kg-LEN | 3 | 3 |
| Total, other adverse events | Part 2: MT-3724 50mcg/Kg-LEN | 0 | 0 |
| Total, serious adverse events | Part 1: MT-3724 10 mcg/Kg-LEN | 1 | 3 |
| Total, serious adverse events | Part 1: MT-3724 25 mcg/Kg-LEN | 1 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03645395
GET https://conductscience.org/api/trials/v1/NCT03645395/results?page=2