NCT03645395

Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Lenalidomide for the Treatment of Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (MT-3724_NHL_003)

A Phase 2a Open-label Study to Investigate Safety and Tolerability (Including the Maximum Tolerated Dose), Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of MT-3724 in Combination With Lenalidomide in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Molecular Templates, Inc. · Industry
• Sex: All
• Age: 18 Years – 101 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of MT-3724 in combination with Lenalidomide in participants with relapsed or refractory B-Cell NHL.

Detailed description

This is a multi-center, open-label two-part study evaluating the safety and tolerability of MT-3724 in combination with Lenalidomide in relapsed or refractory CD20 positive B-cell Lymphoma participants. Part 1: (MT-3724 Dose Escalation) Define the maximum tolerated dose (MTD) of MT-3724 in combination with standard treatment of Lenalidomide 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 Lenalidomide. In addition, the Pharmacokinetics (PK), Pharmacodynamics (PD), immunogenicity and tumor response at the MTD of MT-3724 in combination with Lenalidomide will be more thoroughly evaluated in Part 2. It is anticipated that up to 64 participants will be enrolled. Treatment will continue until disease progression, withdrawal of consent or any other reason.

Conditions

• Non-hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	MT-3724	Experimental treatment with MT-3724 in combination with LEN therapy.

Timeline

• Start date: 2019-04-08
• Primary completion: 2021-03-10
• Completion: 2021-03-10
• First posted: 2018-08-24
• Last updated: 2022-08-16
• Results posted: 2022-08-16

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study