relapsed or refractory diffuse large B-cell lymphoma (DLBCL) MedDRA version: 21.0 Level: PT Classification code 10012822 Term: Diffuse large B-cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 22.0 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: MT-3724
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: N/A
CAS Number: N/A
Current Sponsor code: MT-3724
Concentration unit: mg/ml milligram(s)/millilitr
Sponsors
Molecular Templates, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects must have relapsed or refractory DLBCL - Subjects must have received at least 2 standard of care regimens for NHL treatment - Subjects must have life expectancy of >3 months from the start of treatment - Subjects must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Subjects must not be pregnant or plan to become pregnant during the study until the post-study Follow-up Visit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: - Received anti-CD20 MAb within 84 days before the start of treatment - Subjects who have received anti-CD20 Mab must have levels below a specified threshold to be eligible for study participation - Received approved or investigational treatment for NHL, including radiation therapy to target tumor lesions within 4 weeks, before the start of treatment - Received systemic immunosuppressive agents (except prescribed corticosteroids at doses =<20 mg/day prednisone equivalent) within 2 weeks before the start of treatment - Received any vaccines except injectable flu vaccine (inactivated or recombinant) within 4 weeks before the start of treatment - Received allogeneic stem cell transplant - Evidence of seropositive status for human immunodeficiency virus (HIV), hepatitis B virus (positive for hepatitis B surface antigen (HBsAg) or anti-HBsAg and anti-HBcAg antibodies) or hepatitis C virus (positive for anti-HCV antibody or HCV-RCV-RNA quantitation) at screening - History of cardiovascular, renal, hepatic or any other disease within 3 months before the start of treatment that in the investigator’s opinion, may increase the risks associated with study participation or require treatments that may interfere with the conduct of the study or the interpretation of study results - History of another primary malignancy within the past 3 years (except for ductal breast cancer in situ, non-melanoma skin cancer, prostate cancer not requiring treatment, and cervical carcinoma in situ) - Current evidence of new or growing brain or spinal metastases during screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In Part 3 of this study, up to 100 subjects with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) will be treated with 50 µg/kg/dose of MT-3724, and the primary objective will be to: Determine the efficacy of MT-3724 as monotherapy in subjects with relapsed or refractory DLBCL based on the overall response rate (ORR) by the revised Lugano Classification for Lymphoma adjusted according to LYRIC (lymphoma response to immunomodulatory therapy criteria) hereinafter referred to as “revised Lugano Criteria” (Cheson et al, 2014, 2016). Overall response rate is defined as the proportion of subjects with either a complete response (CR) or a partial response (PR) as determined by independent, blinded central review.;Secondary Objective: Safety Efficacy based on the - overall response rate (ORR) defined as the proportion of subjects with either a CR or a PR as determined by investigator assessment. - duration of tumor response (DOR): Time from initial documentation of tumor response (PR or CR) to disease progression - disease control rate (DCR): Percentage of subjects who have achieved CR, PR and SD (defined as SD for 3 months or longer). - progression-free survival (PFS). PFS is defined as the time from study enrollment to the earliest date of disease progression or death from any cause. - overall survival (OS). Overall survival is defined as the time from study enrollment to death from any cause Pharmacokinetics (PK) Pharmacodynamics (PD) Immunogenicity: anti-drug antibodies (ADA) Quality of life Exploratory Objectives: Immunogenicity: Neutralizing antibodies (NA);Primary end point(s): Determine the efficacy of MT-3724 as monotherapy in subjects with relapsed or refractory DLBCL;Timepoint(s) of evaluation of this end point: 10-14 days following last dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Short-term Safety Follow Up - Long-term Safety Follow Up - Progression-free survival (PFS) - Overall survival (OS) - Duration of tumor response (DOR);Timepoint(s) of evaluation of this end point: - Short-term Safety Follow Up: 30 days (+/-3) after last dose of MT-3724 - Long-term Safety Follow Up: Every 6 months (+/-14 days) after the last dose of MT-3724 until death or loss to follow up - Progression-free survival (PFS): Time from study enrollment to the earliest date of disease progression or death from any cause - Overall survival (OS): Time from study enrollment to death from any cause - Duration of tumor response (DOR): Time from initial documentation of tumor response (CR or PR) to disease progression | — |
Countries
Belarus, Canada, Georgia, Israel, Italy, Mexico, Moldova, Republic of, Poland, Romania, Serbia, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactCorporate Headquarters
Molecular Templates, Inc.
Outcome results
None listed