MT-3724 for the Treatment of Patients with relapsed or refractory DLBC
Research type
Research Study
Full title
Safety, Pharmacodynamics and Efficacy of MT-3724 for the Treatment of Patients with relapsed or refractory DLBCL
IRAS ID
272018
Contact name
David John Wrench
Contact email
Sponsor organisation
Molecular Templates, Inc.
Eudract number
2019-001073-86
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 14 days
Research summary
Research Summary
This is a Phase 2 study to assess the experimental drug MT-3724 in participants with histologically confirmed relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have received 2 or more lines of prior therapy.
MT-3724 is a small part of a monoclonal antibody, which is a protein from animal cells that has been genetically modified, and is made by the immune system to fight infections. MT-3724 targets immune cells that have a marker called CD20 on their surface. It is expected that MT-3724 will attach to the CD20 surface marker on the cancer cells and kill them.
The study is made up of a Screening phase (up to 28 days) to determine the patient’s eligibility, treatment phase (made up of treatment cycles that last 21 days) and a post treatment phase (which includes an End of Treatment visit, a visit 30 days after the last dose and follow-up via phone every 6 months).
All the participants will receive MT-3724 intravenously 6 times in the first 14 days of each cycle. The treatment will continue for up to 6 cycles or until death, disease progression, unacceptable toxicity, withdrawal, or until study discontinuation. Treatment with MT-3724 may be continued for up to 6 additional cycles, if considered appropriate.Up to 100 participants will be enrolled in three stages across multiple sites including, but not limited to, North America and Europe (including the UK). The first stage will consist of 21 participants, the second stage 45 participants, and the third stage 34 participants. The study will proceed to stage 2 if at least 3 participants respond positively from stage 1, and to stage 3 if 11 participants respond positively from stage 1 and 2, unless other considerations indicate otherwise.
The study is being sponsored by Molecular Templates, Inc.Summary of Results
This research study, sponsored by Molecular Templates, Inc., was titled “Safety, Pharmacodynamics and Efficacy of MT-3724 for the Treatment of Patients with Relapsed or Refractory DLBCL,” which seeks to find a more effective treatment for patients with diffuse large B-cell lymphoma (DLBCL) whose tumor did not respond to previous treatments, or had a recurrence of their tumor even after responding to treatment. Subjects were given MT-3724 intravenously at different doses to determine the best possible dose.
The study was divided into multiple parts. Part 1 and Part 2 included 27 subjects and were intended to evaluate safety, tolerability, and efficacy at different doses of the drug MT-3724. Part 3 included 11 subjects and was intended to collect additional safety data on MT-3724. The study was conducted at multiple sites worldwide. The first subject was enrolled on 24 Feb 2015 in Part 1 and the study was stopped during Part 3 on 19 March 2021. The safety and tolerability of MT-3724 was well defined and the study determined an efficacy rate of 41.7% (the number of subjects with a complete or partial response to MT-3724). The most common reported adverse event was peripheral edema in Part 1 and 2 and myalgia, pyrexia, and anemia in Part 3. However, this study and associated studies with MT-3724 closed prematurely due to drug manufacturing concerns.REC name
London - Chelsea Research Ethics Committee
REC reference
20/LO/0559
Date of REC Opinion
2 Jun 2020
REC opinion
Further Information Favourable Opinion