Trial · NCT02361346
Safety, PD & Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL
NCT02361346, Phase 1, Phase 2, Terminated, Molecular Templates, Inc.; results first posted 2022-08-18
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Safety, PD & Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL. Trials, record NCT02361346. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02361346
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, PD & Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL
- NCT number
- NCT02361346
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 38 participants, actual
- Lead sponsor
- Molecular Templates, Inc.
- Conditions
- Non-Hodgkin's B-cell Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Small Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Blood Cancer, Hematological Malignancy
- Interventions
- MT-3724 Phase 1, MT-3724 Phase 2
- First posted
- 2015-02-11
- Last updated
- 2022-08-18
- Results first posted
- 2022-08-18
Source ClinicalTrials.gov
Registered outcomes51
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Number of Participants With Dose Limiting Toxicities of a Single Cycle of MT-3724 | Days 1, 3, 5, 8, 10 and 12 | The MTD is defined to be the dose cohort below which participants experience dose-limiting toxicities during cycle 1. Dose-limiting toxicities were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 |
| Primary | Part 1 and 2: Maximum Observed Concentrations (Cmax) of MT-3274 | Part 1 and 2 : Days 1, 3 and 12 | Blood samples were collected at indicated timepoints for the determination of Cmax of MT-3274. |
| Primary | Part 1 and 2: Time to Achieve Cmax (Tmax) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Blood samples were collected at indicated timepoints for the determination of tmax. |
| Primary | Part 1 and 2: Area Under the Plasma Concentration Time Curve From 0 to 4 Hours (AUC [0-4]), AUC (0-infinity) and AUC From Dosing to Last Measurable Concentration (AUClast) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Blood samples were collected at indicated timepoints for the determination of AUC (0-4), AUC (0-infinity) and AUClast. |
| Primary | Part 1 and 2: Half Life (t1/2) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Blood samples were collected at indicated timepoints for the analysis of t1/2 of MT-3724. |
| Primary | Part 1 and 2: Volume of Distribution (Vz) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Blood samples were collected at indicated timepoints for the analysis of Vz of MT-3724. |
| Primary | Part 1 and 2: Clearance (CL) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Blood samples were collected at indicated timepoints for the analysis of CL of MT-3724. |
| Primary | Part 1 and 2: Absolute Values of Cluster of Differentiation 19 Plus (CD19+) for B-cell Lymphocytes | Part 1 and 2: Cycle 1: Days 8 and 23; Cycle 3: Day1; Cycle 5: Day 1 and Day 120 (end of study) | CD19+ cells in the peripheral blood were counted as measures of malignant B-cells and were measured by flow cytometry. Flow cytometry is a technique for counting and examining microscopic particles with an electronic detection apparatus |
| Primary | Part 1 and 2: Number of Participants With Positive Anti-drug Antibody (ADA) Confirmed | Part 1 and 2: Cycle 1, Day 23; Cycle 2, Day 1; Cycle 3, Day 1; Cycle 4, Day 1; Cycle 5, Day 1 and Day 120 (end of study) | Blood samples were collected to analyze the presence of ADA that bind MT-3724. Number of participants with positive ADA confirmed has been presented. |
| Primary | Part 3: Number of Participants Reporting Serious Treatment-emergent Adverse Events (TEAEs) and Non-serious TEAEs | Up to Day 45 | 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. |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 registered outcomesOutcomes51
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Number of Participants With Dose Limiting Toxicities of a Single Cycle of MT-3724 | Days 1, 3, 5, 8, 10 and 12 | Safety Set comprises of all participants who received any amount of MT-3724 | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1 and 2: Maximum Observed Concentrations (Cmax) of MT-3274 | Part 1 and 2 : Days 1, 3 and 12 | Pharmacokinetic Analysis Set (PAS). All subjects from the Safety Set with sufficient serum concentration data to determine the primary PK parameters. Only those participants with data available at specified timepoints were analyzed. Part 2 was analyzed as a single arm as data was not collected for each dose level separately. | Nanograms per milliliter | GEOMETRIC_MEAN |
| PRIMARY | Part 1 and 2: Time to Achieve Cmax (Tmax) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately. | Hours | MEDIAN |
| PRIMARY | Part 1 and 2: Area Under the Plasma Concentration Time Curve From 0 to 4 Hours (AUC [0-4]), AUC (0-infinity) and AUC From Dosing to Last Measurable Concentration (AUClast) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately. | h*ng/ml | GEOMETRIC_MEAN |
| PRIMARY | Part 1 and 2: Half Life (t1/2) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Pharmacokinetic Analysis Set. Part 2 was analyzed as a single-arm as data was not collected for each dose level separately. | Hour | GEOMETRIC_MEAN |
| PRIMARY | Part 1 and 2: Volume of Distribution (Vz) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately. | Liters | GEOMETRIC_MEAN |
| PRIMARY | Part 1 and 2: Clearance (CL) of MT-3724 | Part 1 and 2: Days 1, 3 and 12 | Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately. | Liters per hour | GEOMETRIC_MEAN |
| PRIMARY | Part 1 and 2: Absolute Values of Cluster of Differentiation 19 Plus (CD19+) for B-cell Lymphocytes | Part 1 and 2: Cycle 1: Days 8 and 23; Cycle 3: Day1; Cycle 5: Day 1 and Day 120 (end of study) | Pharmacokinetic Analysis Set. Part 2 was analyzed as a single arm as data was not collected for each dose level separately. | 10^3 cells per microliter | MEAN |
| PRIMARY | Part 1 and 2: Number of Participants With Positive Anti-drug Antibody (ADA) Confirmed | Part 1 and 2: Cycle 1, Day 23; Cycle 2, Day 1; Cycle 3, Day 1; Cycle 4, Day 1; Cycle 5, Day 1 and Day 120 (end of study) | Pharmacokinetic Analysis Set. Only those participants with data available at specified time points has been presented. Part 2 was analyzed as a single arm as data was not collected for each dose level separately. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 3: Number of Participants Reporting Serious Treatment-emergent Adverse Events (TEAEs) and Non-serious TEAEs | Up to Day 45 | Safety Set. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 outcomesResults by group150
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Number of Participants With Dose Limiting Toxicities of a Single Cycle of MT-3724 | Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) | 0 | Participants | ||
| Part 1: Number of Participants With Dose Limiting Toxicities of a Single Cycle of MT-3724 | Part 1: Cohort 2- 10 mcg/kg/Dose | 0 | Participants | ||
| Part 1: Number of Participants With Dose Limiting Toxicities of a Single Cycle of MT-3724 | Part 1: Cohort 3- 20 mcg/kg/Dose | 0 | Participants | ||
| Part 1: Number of Participants With Dose Limiting Toxicities of a Single Cycle of MT-3724 | Part 1: Cohort 4- 50 mcg/kg/Dose | 0 | Participants | ||
| Part 1: Number of Participants With Dose Limiting Toxicities of a Single Cycle of MT-3724 | Part 1: Cohort 5- 100 mcg/kg/Dose | 2 | Participants | ||
| Part 1: Number of Participants With Dose Limiting Toxicities of a Single Cycle of MT-3724 | Part 1: Cohort 6- 75 mcg/kg/Dose | 0 | Participants | ||
| Part 1 and 2: Maximum Observed Concentrations (Cmax) of MT-3274 | Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) | NA | Geometric Coefficient of Variation NA | Nanograms per milliliter | |
| Part 1 and 2: Maximum Observed Concentrations (Cmax) of MT-3274 | Part 1: Cohort 2- 10 mcg/kg/Dose | NA | Geometric Coefficient of Variation NA | Nanograms per milliliter | |
| Part 1 and 2: Maximum Observed Concentrations (Cmax) of MT-3274 | Part 1: Cohort 3- 20 mcg/kg/Dose | NA | Geometric Coefficient of Variation NA | Nanograms per milliliter | |
| Part 1 and 2: Maximum Observed Concentrations (Cmax) of MT-3274 | Part 1: Cohort 4- 50 mcg/kg/Dose | NA | Geometric Coefficient of Variation NA | Nanograms per milliliter |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 results by groupParticipant flow81
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 and 2 ( Up to Day 112) | STARTED | Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) | 3 | |
| Part 1 and 2 ( Up to Day 112) | STARTED | Part 1: Cohort 2- 10 mcg/kg/Dose | 3 | |
| Part 1 and 2 ( Up to Day 112) | STARTED | Part 1: Cohort 3- 20 mcg/kg/Dose | 3 | |
| Part 1 and 2 ( Up to Day 112) | STARTED | Part 1: Cohort 4- 50 mcg/kg/Dose | 4 | |
| Part 1 and 2 ( Up to Day 112) | STARTED | Part 1: Cohort 5- 100 mcg/kg/Dose | 2 | |
| Part 1 and 2 ( Up to Day 112) | STARTED | Part 1: Cohort 6- 75 mcg/kg/Dose | 6 | |
| Part 1 and 2 ( Up to Day 112) | STARTED | Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) | 6 | |
| Part 1 and 2 ( Up to Day 112) | STARTED | Part 3 | 0 | |
| Part 1 and 2 ( Up to Day 112) | STARTED | Part 4 | 0 | |
| Part 1 and 2 ( Up to Day 112) | COMPLETED | Part 1: Cohort 1 - 5 Micrograms/Kilogram/Dose (mcg/kg/Dose) | 3 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 participant flowAdverse events1,881
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 | Anaemia | Blood and lymphatic system disorders | Part 1: Cohort 1: 5 Micrograms/Kilograms/Dose/Day | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: Cohort 2: 10 mcg/kg/Dose/Day | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: Cohort 3: 20 mcg/kg/Dose/Day | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: Cohort 4: 50 mcg/kg/Dose/Day | 2 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: Cohort 5: 100 mcg/kg/Dose/Day | 1 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: Cohort 6: 75 mcg/kg/Dose/Day | 1 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 3: All MT-3724 Treated Participants | 0 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 4: All MT-3724 Treated Participants | 0 | 0 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Part 1: Cohort 1: 5 Micrograms/Kilograms/Dose/Day | 0 | 3 |
1 to 10 of 1,881Source ClinicalTrials.gov
See all 1,881 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Cohort 1: 5 Micrograms/Kilograms/Dose/Day | 0 | 3 |
| Total, all-cause mortality | Part 1: Cohort 2: 10 mcg/kg/Dose/Day | 0 | 3 |
| Total, all-cause mortality | Part 1: Cohort 3: 20 mcg/kg/Dose/Day | 0 | 3 |
| Total, all-cause mortality | Part 1: Cohort 4: 50 mcg/kg/Dose/Day | 1 | 4 |
| Total, all-cause mortality | Part 1: Cohort 5: 100 mcg/kg/Dose/Day | 0 | 2 |
| Total, all-cause mortality | Part 1: Cohort 6: 75 mcg/kg/Dose/Day | 0 | 6 |
| Total, all-cause mortality | Part 2: Cohort 7- MTD Expansion Cohort (50 or 75 mcg/kg/Dose) | 0 | 6 |
| Total, all-cause mortality | Part 3: All MT-3724 Treated Participants | 1 | 11 |
| Total, all-cause mortality | Part 4: All MT-3724 Treated Participants | 0 | 0 |
| Total, other adverse events | Part 1: Cohort 1: 5 Micrograms/Kilograms/Dose/Day | 3 | 3 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 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/NCT02361346
GET https://conductscience.org/api/trials/v1/NCT02361346/registered?page=2