Overview

Phase I/II, First in Human, Dose Escalation Trial of TL 895 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Relapsed/Refractory Small Lymphocytic Lymphoma

Status:
Recruiting

Trial end date:
2024-02-01

Target enrollment:

Participant gender:

Summary

The purpose of this research study is to determine the safety and tolerability of TL-895. There are 2 parts of this study. Part 1 tested increasing doses of TL-895 to identify the recommended safe dose for participants with relapsed/refractory (R/R) B cell malignancies who failed at least 1 but no more than 3 prior therapies. Part 1 of this study is no longer enrolling participants. Part 2 of this study will test different doses of TL-895 in participants with R/R CLL or SLL who have failed at least 1 prior therapy. Part 2 of this study is randomized (like the flip of a coin) to receive a specific treatment dose. If someone participates in Part 2, the dose they receive will be either 100mg twice a day or 150mg twice a day. Every participant in this study will receive TL-895.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

EMD Serono Research & Development Institute, Inc.
Telios Pharma, Inc.

Collaborator:

Merck KGaA