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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono Research & Development Institute, Inc.; Telios Pharma, Inc.
• Collaborator: Merck KGaA

Criteria

Inclusion Criteria

• Relapsed/refractory CLL or relapsed/refractory SLL

• ECOG performance status of ≤ 2

• Adequate hematologic, hepatic, and renal functions

Exclusion Criteria

• Prior treatment with any BTK or PI3K inhibitors

• History of major organ transplant

• Women who are pregnant or breastfeeding