NCT03265717

DNA Plasmid Encoding a Modified Human Telomerase Reverse Transcriptase (hTERT), Invac-1 in Chronic Lymphocytic Leukemia

A Phase II Study of INVAC-1 as Treatment of Patients With High-risk Chronic Lymphocytic Leukemia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Invectys · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 2 study to assess the efficacy of INVAC-1, a DNA plasmid encoding a modified human telomerase reverse transcriptas (hTERT) protein, at a dose of 800 µg for 6 cycles 4 weeks apart on Minimal Residual Disease (MRD) eradication rate in the bone marrow, either as a single agent in a high risk "watch and wait" group (group 1 - 42 patients) or in combination with ibrutinib (group 2 - 42 patients), in patients with Chronic Lymphocytic Leukemia (CLL). Pharmacodynamics and safety will also be assessed.

Detailed description

The study will be a phase II, open label, single-arm trial of INVAC-1 at a dose of 800 µg in patients with CLL. The primary goal of the study is to achieve MRD negativity in each group. 42 patients are to be included in each study group. Group 1: Untreated high risk "watch and wait" Newly diagnosed patients not eligible for any approved treatment (using NCI Working Group criteria), but having some poor prognosis characteristics (defined by MD Anderson Cancer Center nomogram criteria). Patients will be treated by INVAC-1 for 6 doses at 4-week intervals and then MRD will be assessed. Patients will subsequently be managed as per usual care. For MRD negative patients after INVAC-1 who become MRD+ during follow-up, INVAC-1 can be resumed for 6 months. Group 2: Ibrutinib treated patients Patients who are receiving ibrutinib as 1st or 2nd line treatment. After at least 12 months of ibrutinib, patients will be assessed for MRD. MRD-positive patients will be treated with ibrutinib + INVAC-1 for 6 months and at the end of the combined treatment period, MRD will be assessed. MRD-negative patients (defined as \<0.01% of CLL cells in total cells analyzed) will have the option to stop or continue ibrutinib. Then, they will be followed-up regularly for two years. Patients who become MRD-positive after being MRD-negative will resume ibrutinib single agent.

Conditions

• Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Type	Name	Description
BIOLOGICAL	INVAC-1	Patients are treated by INVAC-1 for 6 cycles at 4-week intervals

Timeline

• Start date: 2018-07-25
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2017-08-29
• Last updated: 2020-07-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study