Cancer Vaccine for Chronic Lymphocytic Leukemia

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: XEME Biopharma Inc.

Must not be taking: Steroids, NSAIDs, Immunosuppressants, others

Disqualifiers: Autoimmune diseases, HIV, Hepatitis, others

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

Compensation: Varies

Number of Visits: 8

Duration: 15 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies a special vaccine made from a patient's own cancer cells and an immune booster to treat chronic lymphocytic leukemia. It targets patients who have not been treated before, aiming to help their immune system recognize and destroy cancer cells.

Research Team

Shuo Ma, MD, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

Adults with untreated chronic lymphocytic leukemia (CLL) showing disease progression but not severe enough to require immediate treatment. Participants must have a certain level of white blood cells, be in good physical condition, and have normal kidney and liver function. Women who can bear children and sexually active men must use contraception. Those with other cancers, immune diseases, or infections that could affect the trial are excluded.

Inclusion Criteria

Patients must have adequate renal and hepatic function:

Serum creatinine less than or equal to 2.0 mg/deciliter (dL)

Total Bilirubin less than or equal to 2.0 mg/dL

Exclusion Criteria

Patients who meet any of the NCI Working Group criteria to initiate treatment for CLL are NOT eligible for participation

Patients who have had or are currently receiving any treatment for CLL, including chemotherapy, corticosteroids, biologic therapy, or immunotherapy are NOT eligible for participation.

Patient who had a stage 1 solid tumor which has been adequately treated with curative intent, and has been in remission for more than 1 year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Oncoquest-CLL vaccine subcutaneously on Day 1 and 15, and then monthly for 3 months

15 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Monthly for 3 months, then every 3 months

Treatment Details

Interventions

• Oncoquest-CLL vaccine

Trial Overview The trial is testing a new vaccine therapy called Oncoquest-CLL for CLL patients. It uses liposomes with cancer cell extracts and interleukin-2 to potentially stimulate the body's immune system to attack leukemia cells.

Participant Groups

Group I: Oncoquest-CLL vaccine treatment Experimental Treatment 1 Intervention

Patients receive Oncoquest-CLL vaccine subcutaneously on Day 1 and 15, and then monthly for 3 months in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

XEME Biopharma Inc.

Lead Sponsor

Trials

2

Recruited

60+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+