Extended Treatment Access Study of MT-3724 for Subjects With Relapsed Non-Hodgkin's B-Cell Lymphoma

NCT02715843 | Unknown

• 1 other identifier: MT-3724_NHL_001_EXT_US
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

This is an active treatment, extended access study open solely to those subjects who have successfully completed the Core and Repeat Dosing portions of the MT-3724\_NHL\_001\_US clinical study and who, in the investigator's judgment, (i) have not had progressive disease while on MT-3724 treatment (i.e.; have shown a complete or partial response or stable disease), (ii) have experienced no clinical or laboratory toxicities that would contraindicate further MT-3724 dosing and (iii) have no acceptable and better alternative treatment available to them.

Conditions

Non-Hodgkin's B-cell Lymphoma

Keywords

CD20; immunotoxin; NHL; non-Hodgkin's lymphoma; lymphoma; cancer; antibodies; immunotherapy; safety; pharmacokinetics; MT-3724; relapsed; refractory

Interventions

MT-3724 DRUG

Intravenous dosing M-W-F X 2 weeks; MT-3724 infusion over 2 hours on each dosing day over 4 week initial cycle and then 3 week repeat cycles for up to 5 total cycles.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible subjects must be adequately informed of all study procedures and fully consent to participation as demonstrated by signing the Informed Consent Form (ICF).
• Eligible subjects must require treatment for their NHL and have:
• tolerated MT-3724 throughout the MT-3724\_NHL\_001\_US Phase I/Ib study (Core and Repeat Dosing),
• successfully completed the Core and Repeat Dosing portions of MT-3724\_NHL\_001\_US Phase I/Ib study as defined by that protocol,
• received no other treatment for their NHL since enrollment in the MT-3724\_NHL\_001\_US Phase I/Ib study,
• maintained stable disease or better throughout that study and
• been assessed by the investigator to have no other acceptable and better treatment options available to them. The investigator must document in the potential subject's medical record that there are no other approved treatment options available and/or appropriate for the potential subject or that the potential subject has declined any other approved treatment options that me be available to them.
• Potential subjects must continue to meet the diagnostic criteria for B-Cell NHL that allowed them to be eligible for the MT-3724\_NHL\_001\_US Phase I/Ib study.
• Potential subjects must have received all approved therapies known to provide clinical benefit for their disease subtype and for which they are eligible or must have refused these treatment options prior to consideration for continued compassionate use treatment with MT-3724 through enrollment in this protocol. In the case of subjects who have lymphomas for which high-dose chemotherapy and autologous stem cell transplantation (HD-ASCT) is considered a standard curative therapy, eligibility for MT-3724 compassionate use requires that the subject's disease relapsed after HD-ASCT, that the subject is not eligible for HD ASCT, or that the subject has refused HD-ASCT.
• Potential subjects with known central nervous system (CNS) metastases may be enrolled if they:
• have previously been treated with radiotherapy for their CNS disease,
• do not require chronic steroid therapy,
• have had computed tomography or magnetic resonance imaging of the brain within 1 month of this study's entry that showed stable disease and
• have no neurological symptoms (excluding Grade 1 or 2 neuropathy).
• Eastern Cooperative Oncology Group (ECOG) performance status of \< 3

You may not qualify if:

• Patients who cannot comply with protocol requirements including clinic visits for intravenous infusions and birth control measures may not be enrolled.
• Female patients who are pregnant or are breast feeding.
• Potential patients with a history of another cancer other than basal cell carcinoma or cervical intraepithelial neoplasia (cervical cancer in situ) may not be enrolled unless it is documented that their previous cancer was treated, they have been disease free for five or more years prior to starting this study and they are in their doctor's judgment at less than 30% risk of relapse of this previous malignancy.
• Patients with a peripheral blood total lymphocyte count of higher than 25,000/mm3 may not be enrolled.
• Patients cannot have experienced a significant (CTCAE Grade 3 or 4 with or without neutropenia) infection within 2 weeks of their first dose of MT-3724.
• Patients are not eligible if they are using any other approved or investigational anti-neoplastic therapies or any other investigational therapies for any other reason.
• Patients may not be receiving systemic corticosteroid therapy at a prednisone dose \> 20 mg/day (or steroid equivalent) within 2 weeks of starting study.
• 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.
• 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.
• Patients with known active Hepatitis C, HIV or a present history of Hepatitis B
• Patients must not have received any vaccines for 28 days prior to administration of their first dose of MT-3724 and should not receive any vaccine during the study or within 28 days after their last dose of MT-3724.
• Patients with a suspected allergy or sensitivity to any component of MT-3724 drug preparation based upon known allergies to compounds of a similar class who have had an anaphylactic or other severe infusion reaction to human immunoglobulin or monoclonal antibody administration are n ot eligible.
• Patients who have had an allogeneic hematopoietic stem cell transplantation are not eligible.
• Patients who have had major surgery within 6 weeks prior to the first dose of study drug or have major surgery planned during the first 12 weeks after MT-3724 has finished.

Sponsors & Collaborators

• Molecular Templates, Inc.: lead

Study Sites (3)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Location

MD Anderson Cancer Center

Houston, Texas, United States

Location

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 22, 2016
• Last Updated: October 11, 2019

Record last verified: 2019-10

Locations

US (3)