Summary

for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion
Elizabeth Brem, MD

Description

Summary

The purpose of this study is to evaluate the safety and tolerability of MT-3724 in combination with gemcitabine and oxaliplatin (GEMOX) in subjects with relapsed or refractory B-Cell NHL.

Official Title

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Gemcitabine and Oxaliplatin for the Treatment of Subjects With Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma

Details

This is a multi-center, open-label two-part study evaluating the safety and tolerability of MT-3724 in combination with GEMOX in relapsed or refractory B-cell Lymphoma patients.

Part 1: (MT-3724 Dose Escalation) Define the maximum tolerated dose (MTD) of MT-3724 in combination with standard treatment of GEMOX

Part 2: (MTD Expansion Cohort) Confirm the safety and tolerability of the MTD of MT-3724 from Part 1 in the MTD Expansion Cohort, where MT-3724 will be given at the MTD in combination with GEMOX. In addition, the PK, PD, immunogenicity and tumor response at the MTD of MT-3724 in combination with GEMOX will be more thoroughly evaluated in Part 2.

It is anticipated that up to 64 patients will be enrolled. Treatment will continue for up to four 28 days cycles. If the subject exhibits SD, CR or PR after the end of Cycle 4 and the investigator determines that the benefit-risk ratio is favorable, then the treatment with MT-3724 may be continued after discussion with the sponsor. Continuation of GEMOX is at investigators discretion.

Keywords

Non-hodgkin Lymphoma,B Cell Refractory Diffuse Large B-Cell Lymphoma Relapsed Diffuse Large B-Cell Lymphoma Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Gemcitabine Oxaliplatin MT-3724 10mcg/kg-GEMOX MT-3724 25mcg/kg-GEMOX MT-3724 50mcg/kg- GEMOX

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Men or Women, age 18 years or older
  2. Histology based upon bone marrow biopsies and/or fine needle aspirates as the sole means of diagnosis are not acceptable. All subtypes of B-cell NHL may be considered for Part 1 (MT-3724 dose escalation). Only DLBCL may be considered for Part 2 (expansion cohort)
  3. Subjects must have received all available approved therapies for NHL. Those subjects who are ineligible for approved therapies in the opinion of the investigator, or have refused such therapies, will be eligible.
  4. Measurable disease (≥1 cm) by Lugano Classification for NHL.
  5. Eastern Cooperative Oncology Group (ECOG) performance score of ≤2.
  6. Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to initiating dosing. Male and female subjects with reproductive potential must agree to use acceptable contraceptive methods until the end of study visit.
  7. Adequate kidney function, assessed by the estimated glomerular filtration rate (eGFR) ≥60 mL/minmCPK-EPI equation.

You CAN'T join if...

  1. Patients who cannot comply with protocol requirements including clinic visits for intravenous infusions and birth control measures may not be enrolled.
  2. 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, or any other previous cancer curatively treated >2 years before the start of treatment.
  3. Current evidence of new or growing brain or spinal metastases during screening.
  4. History of allogeneic hematopoietic stem cell transplant within 180 days before the start of treatment.
  5. Current evidence of acute or chronic Graft versus Host Disease.
  6. Current evidence of CTCAE Grade >1 toxicity (except for hair loss, and those toxicities listed in other eligibility criteria) before the start of treatment.
  7. Current evidence of incomplete recovery from surgery before the start of treatment, or planned surgery at any time until the Last Study Assessment Visit, except minor elective interventions deemed acceptable by the investigator.
  8. History or current evidence of significant (CTCAE Grade ≥2) infection or wound within 4 weeks before the start of treatment.
  9. Patients with uncontrolled or severe cardiovascular disease, including myocardial infarct or unstable angina within 6 months prior to start of study treatment, New York Heart Association (NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, or cardiac amyloidosis may not be enrolled.
  10. . Patients with a known history of drug abuse or any chronic neurologic, psychiatric, endocrine, metabolic, immunologic, hepatic or renal disease (including a history of hemolytic uremic syndrome) that in the opinion of the Investigator would adversely affect study participation.
  11. . Patients with known active Hepatitis C, HIV or a present history of Hepatitis B
  12. . Women who are pregnant or breastfeeding.
  13. . History or current evidence of hypersensitivity to any study drugs, or current evidence of hypersentivity requiring systemic steroid doses ≥20 mg/day Prednisone equivalent
  14. . Received any amount of anti-CD20 MAb therapy within the following periods before the start of treatment
  15. Rituximab (Rituxan®): 84 days; if a subject had received rituximab within 37 Weeks before the start of treatment, then a serum rituximab level must be negative (<500 ng/mL) at the screening period
  16. Obinutuzumab (Gazyva®): 184 days
  17. Ofatumumab (Arzerra®): 88 days
  18. . Received therapy for NHL (except anti-CD20 Mab listed above) within 4 weeks before the start of treatment
  19. . Received radiotherapy to tumor lesions that would be chosen as target lesions (measurable disease) within 4 weeks before the start of treatment, unless the lesion exhibited objective progression between the radiotherapy and the screening according to the Lugano Classification for NHL.
  20. Palliative radiotherapy to non-target lesions is allowed at the investigator's discretion after consultation with the Medical Monitor and sponsor.
  21. . Received systemic immune modulators within 2 weeks before the start of treatment including but not limited to systemic corticosteroids >20 mg/day of prednisone equivalent, cyclosporine and tacrolimus. Corticosteroids for pre-medication and NSAIDs are permitted.
  22. . Received any investigational drug treatment within 4 weeks or within 5 half-lives of the therapeutic agent before the start of treatment, whichever is longer, until EoT Visit

Locations

  • UC Irvine Health / Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States
  • Sarcoma Oncology accepting new patients
    Santa Monica California 90403 United States

Lead Scientist

  • Elizabeth Brem, MD
    Assistant Health Sciences Professor, Medicine. Authored (or co-authored) 7 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Molecular Templates, Inc.
ID
NCT03488251
Phase
Phase 2
Study Type
Interventional
Last Updated