Pharmacokinetics (PK), Pharmacodynamics (PD), Safety, Tolerability of Multiple Dose Regimens of MT-3724 for the Treatment of Patients With Relapsed Chronic B-cell Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Small Lymphocytic Leukemia Clinical Trial

Official title:
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 for the Treatment of Patients With Relapsed Chronic B-cell Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Status Withdrawn

Clinical Trial Summary

This Phase I, multiple ascending dose study will seek to enroll subjects with relapsed/refractory Chronic B-cell Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) with confirmed and measurable disease who have received standard treatment with at least one anti-CD20 antibody (e.g.; rituximab, ofatumumab) containing front-line regimen that resulted in initial response, followed by relapse/recurrence and who are not eligible for any further approved biologic therapy, chemotherapy and/or autologous stem transplantation and/or refuse alternative approved therapies and/or are unlikely to achieve clinical benefit from any therapy of higher priority by Investigator assessment.

Clinical Trial Description

This study is intended to provide investigators and sponsor with the following information regarding the investigational new drug MT-3724 in patients with relapsed/refractory Chronic B-cell Lymphocytic Leukemia or Small Lymphocytic Lymphoma:

The maximum dose of a single course of MT-3724 given as intravenous (IV) infusions on Days 1, 3, 5, 8, 10 and 12 at which there are negligible side effects and/or at which maximum serum levels and/or at which maximum effect on blood lymphocytes are observed. Four dose levels will be investigated.

The changes in MT-3724 serum levels and blood lymphocytes over time following IV doses at different points in the study.

The changes and kinds of clinical and laboratory effects and side effects that may occur over repeated courses of MT-3724 The changes in each subject's immune status and their CLL or SLL following one or more cycles of 6 infusions. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Chronic B-cell Lymphocytic Leukemia
Leukemia
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Small Lymphocytic Leukemia

Clinical Trial Details

NCT number	NCT02556346
Study type	Interventional
Source	Molecular Templates, Inc.
Contact
Status	Withdrawn
Phase	Phase 1
Start date	November 2015
Completion date	December 2016

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04189952` - Acalabrutinib in Combination With R-ICE For Relapsed or Refractory Lymphoma	Phase 2
Terminated	`NCT00543114` - Dose Escalation Study of Revlimid With Fludarabine-Rituximab for CLL/SLL	Phase 1
Active, not recruiting	`NCT03207555` - Ibrutinib as Early Therapy in Chronic Lymphocytic Leukemia (CLL)	Phase 2
Completed	`NCT01066663` - Pyrimethamine for the Treatment of Relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma	Phase 1/Phase 2
Active, not recruiting	`NCT00109356` - Study of AQ4N in Patients With Non Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, or Small Lymphocytic Leukemia	Phase 1/Phase 2
Recruiting	`NCT05624554` - A Study of Nemtabrutinib vs Chemoimmunotherapy for Participants With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Without TP53 Aberrations (MK-1026-008, BELLWAVE-008)	Phase 3
Completed	`NCT05621148` - REfractorinesS to Ibrutinib BTKi and Systemic Targeted Therapy
Terminated	`NCT02361346` - Safety, PD & Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL	Phase 1/Phase 2
Completed	`NCT03329950` - A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies	Phase 1
Active, not recruiting	`NCT04018248` - BR101801 in Adult Patients With Advanced Hematologic Malignancies( Phase I)	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.