NCT02715843

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

Extended Treatment Access Study of MT-3724 for Subjects With Relapsed Non-Hodgkin's B-Cell Lymphoma Who Have Completed Phase I/Ib Study MT-3724_NHL_001_US

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Molecular Templates, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Each treatment cycle will consist of 6 doses of MT-3724 to be administered over 12 days followed by at least 9 days of observation but longer intervals between dosing cycles will be allowed at the investigator's discretion (e.g., 6 doses of MT-3724 over 12 days followed by 16 days observation). Subjects in this extension study may continue to receive up to 6 additional cycles in the absence of clear disease progression or toxicity. If a subject achieves complete remission, two additional cycles will be attempted, after which dosing may be suspended prior to completion of the maximum 6 cycles.

Conditions

• Non-Hodgkin's B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	MT-3724	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.

Timeline

• First posted: 2016-03-22
• Last updated: 2019-10-11

Locations

3 sites across 1 country: United States