A study of MT-3724 investigational drug for the treatment of patients with resistant or recurring B-cell cancer
- Conditions
- relapsed or refractory diffuse large B-cell lymphoma (DLBCL)MedDRA version: 21.0Level: PTClassification code 10012822Term: Diffuse large B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 22.0Level: PTClassification code 10029547Term: Non-Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-001073-86-ES
- Lead Sponsor
- Molecular Templates, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method