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-GB
- Lead Sponsor
- Molecular Templates, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 108
•Male and female subjects =18 years of age at the time of informed consent.
•Subjects must have relapsed or refractory diffuse large B-cell lymphoma (DLBCL) according to the Revised European American Lymphoma/World Health Organization (REAL/WHO) classification [ (Swerdlow SH, 2016)]. Subjects must have proof of CD20+ DLBCL, based on either:
a. historical biopsies (obtained with diagnosis of relapsed or refractory
disease), or
b. fresh biopsies
c. bone marrow biopsy, excisional lymph node biopsy, and core biopsy of any involved organ are all acceptable methods; Fine Needle Aspirate (FNA) is not acceptable.
NOTE: Composite lymphoma (DLBCL and indolent histology in the same specimen) is also acceptable.
•Subjects must have received at least 2 standard of care regimens (including anti-CD20 antibody therapy) for NHL treatment.
a. Subjects whose prior therapy includes chimeric antigen receptor T-cell (CAR-T) therapy are eligible.
b. Subjects who underwent stem cell transplant (SCT) >100 days for autologous SCT or >180 days for allogeneic SCT before study drug administration and exhibited a full hematological recovery (consistent with the existing inclusion criteria requirements and without peripheral red blood cell [PRBC] or platelet transfusions within 2 weeks of C1D1) prior to relapse are eligible.
c. Subjects who have been ineligible for standard of care NHL treatment(s) may be eligible at the investigator's discretion, upon sponsor approval.
•Subjects must have at least 1 bi-dimensional tumor lesion at screening that is measurable by CT or MRI according to the Lugano criteria [(Cheson BD, 2014)]. Bi-dimensionally measurable tumor lesion by CT/MRI is defined as longest diameter of >1.5 cm for lymph nodes and >1.0 cm for extranodal disease.
•Subjects must have life expectancy of >3 months from the start of treatment.
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 33
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75
Subjects who meet ANY of the following criteria must be excluded:
• Received any amount of anti-CD20 mAbs within the following periods before the start of treatment:
a. Rituximab (Rituxan®/MabThera® or rituximab biosimilar): within 84 days (12 weeks); if a subject has received rituximab within 37 weeks before the start of treatment, then serum rituximab level must be negative (<500 ng/mL) at screening.
b. Obinutuzumab (Gazyva®/Gazyvaro®): 184 days.
c. Ofatumumab (Arzerra®): 88 days.
• Received approved or investigational treatment for NHL (except anti- CD20 mAbs and radioimmunoconjugates) within 4 weeks before the start of treatment. For small molecules (MW <0.9 kDa), the washout is 5 half-lives or at least 2 weeks. Radioimmunoconjugates are excluded within 12 weeks before the start of treatment.
•Current evidence of hypersensitivity or other underlying illness requiring systemic corticosteroids at doses >20 mg/day prednisone equivalent
•Current evidence of uncontrolled HIV, HBV or HCV at screening.
Serology testing is not required if seronegativity is documented in the medical history, and if there are no clinical signs suggestive of HIV or hepatitis infections, or suspected exposure. The following exceptions apply for subjects with positive viral serology:
a. Subjects with HIV and an undetectable viral load and CD4+ T-cell (CD4+) counts = 350 cells/mL may be enrolled, but must be taking appropriate opportunistic infection prophylaxis, if clinically relevant.
b. Subjects with positive HBV serology are eligible if they have an undetectable viral load and the subject will receive antiviral prophylaxis for potential HBV reactivation per institutional guidelines.
c. Subjects with positive HCV serology are eligible if quantitative PCR for plasma HCV RNA is below the lower limit of detection. Concurrent antiviral HCV treatment per institutional guidelines is allowed.
•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 or current evidence of neoplastic disease that is histologically distinct from NHL, except cervical carcinoma in situ, superficial noninvasive bladder tumors, curatively treated Stage I-II non-melanoma skin cancer. Subjects with prior, curatively treated cancer >2 years ago before the start of treatment can be enrolled.
• Current evidence of new or growing brain or spinal metastases during screening. Subjects with known brain or spinal metastases may be
eligible if they:
a. Had radiotherapy or another appropriate therapy for the brain or spinal metastases; concurrent prophylactic treatment is allowed
b. Neurologic symptoms must be stable and no worse than Grade 2
c. Have evidence of stable brain or spinal disease on CT or MRI scan obtained within 4 weeks before signing the informed consent and compared with prior imaging results
d. Do not require steroid therapy (or, if applicable, have been stable on dose of no more than prednisone 20 mg/day or equivalent by C1D1)
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