Trial · NCT03488251
PK,PD,Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Gemcitabine and Oxaliplatin for the Treatment of Patients With Relapsed/Refractory Diffuse Large B Cell Non-Hodgkin's Lymphoma
NCT03488251, 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. PK,PD,Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Gemcitabine and Oxaliplatin for the Treatment of Patients With Relapsed/Refractory Diffuse Large B Cell Non-Hodgkin's Lymphoma. Trials, record NCT03488251. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03488251
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PK,PD,Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Gemcitabine and Oxaliplatin for the Treatment of Patients With Relapsed/Refractory Diffuse Large B Cell Non-Hodgkin's Lymphoma
- NCT number
- NCT03488251
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Molecular Templates, Inc.
- Conditions
- Non-hodgkin Lymphoma,B Cell, Refractory Diffuse Large B-Cell Lymphoma, Relapsed Diffuse Large B-Cell Lymphoma
- Interventions
- MT-3724, Gemcitabine, Oxaliplatin
- First posted
- 2018-04-04
- Last updated
- 2022-08-16
- Results first posted
- 2022-08-16
Source ClinicalTrials.gov
Registered outcomes12
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 Dose Limiting Toxicities (DLTs) | Up to 168 Days | A DLT is any treatment-emergent adverse event (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 Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 168 Days | An AE is as any untoward medical occurrence in a participant 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 intervention(s). A SAE is any AE that is fatal or life-threatening, permanently disabling (incapacitating or interfering with the ability to resume usual life patterns), results in unplanned in-subject hospitalization or prolongation of an existing hospitalization, results in a congenital abnormality or birth defect, or any other situation that require medical or scientific judgement. Number of participants with common \>=0 percent (%) TEAEs and SAEs are presented. |
| Secondary | Part 1 and 2: Maximum Concentration (Cmax) Following Administration of MT-3724 | Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles) | Blood samples were planned to be collected at indicated time points for pharmacokinetic (PK) analysis of MT-3724. PK Population consisted of all participants who received at least one dose of MT-3724 and have at least one post-Baseline PK value. |
| Secondary | Part 1 and 2: Area Under the Plasma Concentration Time Curve (AUC) Following Administration of MT-3724 | Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles) | Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724. |
| Secondary | Part 1 and 2: Time to Maximum Plasma Concentration (Tmax) Following Administration of MT-3724 | Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles) | Blood samples were planned to be collected at indicated time points for PK analysis of MT-3724. |
| Secondary | Part 1 and 2: Number of Participants With Immunophenotyping Data Outside the Reference Range | Up to 168 Days | Blood samples were planned to be collected at indicated time points for analysis of immunophenotyping parameters which included cluster of differentiation (CD)3 (Percentage \[%\] and absolute), CD4 (% and absolute), CD8 (% and absolute), CD4:CD8 ratio, CD19 (% and absolute), Natural Killer (NK) cells (% and absolute), naïve B cells (% and absolute), non-switched memory B cells (% and absolute), class-switched memory B cells, Immunoglobulin (Ig)M only memory B cells (% and absolute), and total memory B cells (% and absolute). |
| Secondary | Part 1 and 2: Number of Participants With Anti-drug Antibody Titer | Up to 168 Days | Blood samples were planned to be collected at indicated time points for analysis of anti-drug antibody titer. |
| Secondary | Part 1 and 2: Number of Participants With Positive Neutralizing Antibodies | Up to 168 Days | Blood samples were planned to be collected at indicated time points for analysis of positive neutralizing antibodies. |
| Secondary | Part 1 and 2: Objective Response Rate | Up to 168 Days | Objective response rate is defined as the participants with a reduction in tumor size (Partial Response \[PR\] or Complete Response \[CR\]) using the Lugano Classification for Lymphoma, adjusted according to Lymphoma response to immunomodulatory therapy criteria (LYRIC). |
| Secondary | Part 1 and 2: Disease Control Rate | Up to 168 Days | Disease Control rate is defined as participants with objective response of CR, PR or stable disease (SD) defined as SD for 3 months or longer from the Baseline scan. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 Dose Limiting Toxicities (DLTs) | Up to 168 Days | Safety Population consisted of all participants who received at least 1 dose of any study drug (either MT-3724, or gemcitabine or oxaliplatin). Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 168 Days | Safety Population. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1 and 2: Maximum Concentration (Cmax) Following Administration of MT-3724 | Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles) | PK Population. Data was not calculated for Part 1: Cohort 1 due to high proportion of non-quantifiable values (\>30% of values were imputed). Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Micrograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part 1 and 2: Area Under the Plasma Concentration Time Curve (AUC) Following Administration of MT-3724 | Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles) | PK Population. Data was not calculated for Part 1: Cohort 1 due to high proportion of non-quantifiable values (\>30% of values were imputed). Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Hours*micrograms per milliliter | GEOMETRIC_MEAN |
| SECONDARY | Part 1 and 2: Time to Maximum Plasma Concentration (Tmax) Following Administration of MT-3724 | Cycle(C)1:Day1:Predose,10 minutes(min) before end of treatment(EOT),5,30 min,1,2,3,4 hours after EOT,Days5,12:Predose,10 min before EOT,5min,2hours after EOT;C2,C3,C4:Day1:Predose,10min before EOT,5 min after EOT(C1 is 42-days;C2,C3,C4 are 28-days cycles) | PK Population. Data was not calculated for Part 1: Cohort 1 due to high proportion of non-quantifiable values (\>30% of values were imputed). Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Hours | MEDIAN |
| SECONDARY | Part 1 and 2: Number of Participants With Immunophenotyping Data Outside the Reference Range | Up to 168 Days | Safety Population. Data was not calculated for Part 1: Cohort 1 as 100% of data was below limit of quantification at all time points. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1 and 2: Number of Participants With Anti-drug Antibody Titer | Up to 168 Days | Immunogenicity population: All participants who received at least one dose of MT-3724 and have at least one post-Baseline immunogenicity assessment. Data was not calculated for Part 1: Cohort 1 as 100% of data was below limit of quantification at all time points. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1 and 2: Number of Participants With Positive Neutralizing Antibodies | Up to 168 Days | Immunogenicity population. Data was not calculated for Part 1: Cohort 1 as 100% of data was below limit of quantification at all time points. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1 and 2: Objective Response Rate | Up to 168 Days | Efficacy Population: All participants who received at least 1 dose of any study drug and have the Baseline tumor assessment as well as at least one post-Baseline tumor assessment. Only those participants with data available at the specified time points were analyzed. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part 1 and 2: Disease Control Rate | Up to 168 Days | Efficacy Population. Only those participants with data available at the specified time points were analyzed. Data could not be calculated for Part 1: Cohort 1 as no participants had a confirmed CR or PR. Data was not collected for Part 1 (Cohorts 2 and 3) and Part 2 due to early termination of the trial. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group13
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 Dose Limiting Toxicities (DLTs) | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | 2 | Participants | ||
| Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Part 1 Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | TEAEs | 8 | Participants | |
| Part 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Part 1 Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | SAEs | 4 | Participants | |
| Part 1 and 2: Maximum Concentration (Cmax) Following Administration of MT-3724 | Part 1 Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | NA | Geometric Coefficient of Variation NA | Micrograms per milliliter | |
| Part 1 and 2: Area Under the Plasma Concentration Time Curve (AUC) Following Administration of MT-3724 | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | NA | Geometric Coefficient of Variation NA | Hours*micrograms per milliliter | |
| Part 1 and 2: Time to Maximum Plasma Concentration (Tmax) Following Administration of MT-3724 | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | NA | Full Range NA to NA | Hours | |
| Part 1 and 2: Number of Participants With Immunophenotyping Data Outside the Reference Range | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | NA | Participants | ||
| Part 1 and 2: Number of Participants With Anti-drug Antibody Titer | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | NA | Participants | ||
| Part 1 and 2: Number of Participants With Positive Neutralizing Antibodies | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | NA | Participants | ||
| Part 1 and 2: Objective Response Rate | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | 3 | Participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1:Dose Escalation (Up to 168 Days) | STARTED | Part 1 Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | 8 | |
| Part 1:Dose Escalation (Up to 168 Days) | STARTED | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | 0 | |
| Part 1:Dose Escalation (Up to 168 Days) | STARTED | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | 0 | |
| Part 1:Dose Escalation (Up to 168 Days) | STARTED | Part 2: MT-3724/ GEM/ OX | 0 | |
| Part 1:Dose Escalation (Up to 168 Days) | COMPLETED | Part 1 Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | 0 | |
| Part 1:Dose Escalation (Up to 168 Days) | COMPLETED | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | 0 | |
| Part 1:Dose Escalation (Up to 168 Days) | COMPLETED | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | 0 | |
| Part 1:Dose Escalation (Up to 168 Days) | COMPLETED | Part 2: MT-3724/ GEM/ OX | 0 | |
| Part 1:Dose Escalation (Up to 168 Days) | NOT COMPLETED | Part 1 Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | 8 | |
| Part 1:Dose Escalation (Up to 168 Days) | NOT COMPLETED | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events384
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 | Nausea | Gastrointestinal disorders | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | 7 | 8 | |
| other | Nausea | Gastrointestinal disorders | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | 0 | 0 | |
| other | Nausea | Gastrointestinal disorders | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | 0 | 0 | |
| other | Nausea | Gastrointestinal disorders | Part 2: MT-3724/ GEM/ OX | 0 | 0 | |
| other | Diarrhea | Gastrointestinal disorders | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | 3 | 8 | |
| other | Diarrhea | Gastrointestinal disorders | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | 0 | 0 | |
| other | Diarrhea | Gastrointestinal disorders | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | 0 | 0 | |
| other | Diarrhea | Gastrointestinal disorders | Part 2: MT-3724/ GEM/ OX | 0 | 0 | |
| other | Abdominal pain | Gastrointestinal disorders | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | 2 | 8 | |
| other | Abdominal pain | Gastrointestinal disorders | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | 0 | 0 |
1 to 10 of 384Source ClinicalTrials.gov
See all 384 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | 0 | 8 |
| Total, all-cause mortality | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | 0 | 0 |
| Total, all-cause mortality | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | 0 | 0 |
| Total, all-cause mortality | Part 2: MT-3724/ GEM/ OX | 0 | 0 |
| Total, other adverse events | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | 8 | 8 |
| Total, other adverse events | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | 0 | 0 |
| Total, other adverse events | Part 1: Cohort 3: MT-3724 50 mcg/kg/ GEM/ OX | 0 | 0 |
| Total, other adverse events | Part 2: MT-3724/ GEM/ OX | 0 | 0 |
| Total, serious adverse events | Part 1: Cohort 1: MT-3724 10 mcg/kg/ GEM/ OX | 4 | 8 |
| Total, serious adverse events | Part 1: Cohort 2: MT-3724 25 mcg/kg/ GEM/ OX | 0 | 0 |
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.
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