CG-806 for Leukemia and Non-Hodgkin's Lymphoma

Recruiting at 29 trial locations

Overseen By Nawazish Khan, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Aptose Biosciences Inc.

Must not be taking: Investigational drugs

Disqualifiers: GVHD, Leptomeningeal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

36 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being done to evaluate the safety, tolerability and effectiveness of Oral CG-806 for the treatment of patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or Non-Hodgkin's Lymphomas who have failed or are intolerant to two or more lines of established therapy or for whom no other treatment options are available.

Research Team

Rafael Bejar, MD, PhD

Principal Investigator

Aptose Biosciences Inc.

Eligibility Criteria

This trial is for adults over 18 with chronic lymphocytic leukemia, small lymphocytic lymphoma, or Non-Hodgkin's Lymphomas who haven't responded to at least two treatments. They must be able to swallow pills and have a life expectancy of more than 2 months. People with severe immune conditions, blood clotting issues, uncontrolled brain disease or anemia are not eligible.

Inclusion Criteria

You are expected to live for at least 2 more months.

My blood counts are within normal ranges, unless due to my condition.

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

I do not have uncontrolled brain or spinal cord disease, autoimmune blood disorders, or severe metabolic issues.

You have taken any experimental medication within 2 weeks before starting this study.

I have GVHD and need drugs to suppress my immune system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

CG-806 is given orally in ascending doses to determine the maximum tolerated dose or recommended dose

28 days

Cycle 1 (28 days)

Cohort Expansion

Up to 100 patients are enrolled at the recommended dose to further evaluate safety and efficacy

Up to 10 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CG-806

Trial Overview The study tests the safety and effectiveness of CG-806 taken orally by patients with certain types of blood cancers that have not improved after previous therapies or when no other treatment options exist.

Participant Groups

Group I: Dose Escalation and Expansion Experimental Treatment 1 Intervention

CG-806 will be given orally in ascending doses in patients with relapsed or refractory CLL/SLL or Non-Hodgkin's Lymphomas (escalation cohort), until the maximum tolerated dose or recommended dose is reached. Followed by up to 100 patients enrolled in the expansion cohort at the recommended dose.

Who Is Running the Clinical Trial?

Aptose Biosciences Inc.

Lead Sponsor

Trials

8

Recruited

850+