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

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an oral treatment called CG-806 for individuals with certain blood cancers, such as chronic lymphocytic leukemia (CLL) and Non-Hodgkin's Lymphomas. The main goal is to determine if the treatment is safe and effective for those who have not succeeded with at least two other treatments. Participants should have experienced limited success with previous options. The trial involves administering the medication in increasing doses to identify the optimal amount for treatment effectiveness. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you have taken other investigational drugs within 14 days before starting the study treatment.

Is there any evidence suggesting that CG-806 is likely to be safe for humans?

Research has shown that CG-806 is being tested for safety in patients with certain types of leukemia and lymphoma. It targets individuals who haven't responded to other treatments. In earlier studies, patients received increasing doses of CG-806 to determine the optimal dose. This process helps doctors understand the maximum safe dosage for the body.

Specific safety data remains limited, but since the trial is in its early stages, researchers closely monitor for side effects. At this stage, they prioritize ensuring the treatment's safety before expanding to larger groups.

Although detailed side effect reports are not yet available, the trial is carefully designed to identify potential issues and establish the safest dose. If CG-806 has approval for other uses, it suggests some level of safety. However, discussing its implications with a doctor is essential. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for leukemia and Non-Hodgkin's lymphoma, which often involve chemotherapy or targeted therapies like BTK inhibitors, CG-806 is unique because it targets multiple pathways involved in cancer cell growth and survival. This treatment is given orally, which can be more convenient and less invasive than traditional intravenous options. Researchers are excited about CG-806 because it has the potential to overcome resistance seen in other therapies, offering hope for patients with relapsed or refractory conditions.

What evidence suggests that CG-806 might be an effective treatment for leukemia and non-Hodgkin's lymphoma?

Research has shown that CG-806 holds promise for treating certain blood cancers. In studies, CG-806 blocked key proteins that aid cancer cell survival and growth. For patients with chronic lymphocytic leukemia (CLL), the treatment altered blood cell levels, indicating an effect on the cancer cells. It also targets and disrupts important communication pathways in cancer cells, potentially preventing diseases like Non-Hodgkin's Lymphoma from worsening. Early results in a few patients suggest that CG-806 might be effective when other treatments have failed. Participants in this trial will receive CG-806 in a dose escalation and expansion study to determine the optimal dosing for effectiveness and safety. ^{1 2 5 6 7}

Who Is on the Research Team?

Rafael Bejar, MD, PhD

Principal Investigator

Aptose Biosciences Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03893682

A Study of CG-806 in Patients With Relapsed or Refractory ... 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 ...

2. aptose.com aptose.com/news-media/press-releases/detail/184/aptose-presents-early-phase-1ab-cg-806-clinical-findings

Aptose Presents Early Phase 1a/b CG-806 Clinical ... CG-806 treatment led to lymphocytosis in two CLL patients and delivered complete inhibition of phospho-BTK and multiple oncogenic survival ...

3. ashpublications.org ashpublications.org/blood/article/134/Supplement_1/5477/425193/A-Phase-1-a-b-Dose-Escalation-Trial-to-Evaluate

A Phase 1 a/b Dose Escalation Trial to Evaluate the Safety ... CONCLUSIONS: CG-806 is an oral, non-covalent pan-BTK/pan-FLT3 inhibitor designed to suppress multiple oncogenic driver and compensatory ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0006497118714110

A Phase 1 a/b Dose Escalation Study of the Mutation ... Among three classic CLL patients placed on study, all experienced on-target lymphocytosis upon initiation of CG-806 therapy, as well as ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8927405/

Dual BTK/SYK inhibition with CG-806 (luxeptinib) disrupts ... Dual BTK/SYK inhibition with CG-806 (luxeptinib) disrupts B-cell receptor and Bcl-2 signaling networks in mantle cell lymphoma.

6. aptose.com aptose.com/clinical-trials/luxeptinib-for-b-cell

Luxeptinib for CLL & NHL Aptose Biosciences is sponsored a phase 1 a/b trial to assess the safety of CG-806 in patients with CLL/SLL or non-Hodgkin's lymphomas.

7. mayo.edu mayo.edu/research/clinical-trials/cls-20474207

A Study of CG-806 in Patients with Relapsed or Refractory ... The purpose of this study is to evaluate the safety, tolerability and effectiveness of CG-806 for the treatment of patients with the condition of chronic ...