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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new vaccine treatment for individuals with chronic lymphocytic leukemia (CLL) who have not received prior treatment. The goal is to determine if the Oncoquest-CLL vaccine can safely enhance the immune system to combat cancer cells. Participants receive the vaccine, made from their own cancer cells and an immune booster, to assess its safety and effectiveness. The trial seeks individuals diagnosed with CLL who are experiencing disease progression but have not yet started treatment. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

If you are currently taking steroids, NSAIDs (like ibuprofen), or any chronic immunosuppressive drugs, you will need to stop them at least one week before joining the trial. The trial does not specify other medications, so it's best to discuss your specific situation with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the Oncoquest-CLL vaccine is being tested for safety in individuals with chronic lymphocytic leukemia. Early results suggest that the vaccine aims to help the body's immune system fight cancer cells by using proteins from the patient's own cancer cells, along with an immune booster called interleukin-2.

As this is an early study, the primary focus is on ensuring the vaccine's safety and assessing how well participants tolerate it. The goal is to determine if any side effects are manageable. While specific information on side effects isn't available yet, early trials like this typically involve a limited number of participants. Generally, Phase 1 trials ensure that any side effects are tolerable for participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the Oncoquest-CLL vaccine because it represents a novel approach in treating chronic lymphocytic leukemia (CLL). Unlike standard treatments such as chemotherapy or targeted therapies that attack cancer cells directly, this vaccine aims to stimulate the patient's immune system to recognize and fight the leukemia cells. This mechanism of action could potentially offer a more personalized and less toxic alternative to current therapies. Additionally, the vaccine is administered subcutaneously, which might be more convenient compared to intravenous treatments, making it a promising option for patients.

What evidence suggests that this treatment might be an effective treatment for chronic lymphocytic leukemia?

Research shows that the Oncoquest-CLL vaccine is designed to help the immune system identify and attack cancer cells in people with chronic lymphocytic leukemia. This vaccine combines parts of a person's own cancer cells with interleukin-2, a substance that boosts the immune system. Early studies of similar vaccines have demonstrated strong T-cell responses, crucial for fighting cancer, lasting more than two years after just two doses. This method is promising because it trains the body's immune system to specifically target and destroy cancer cells. While direct data on Oncoquest-CLL's effectiveness is still being gathered, the strategy behind it is supported by encouraging early results in similar treatments. ^{1 2 3 5 6}

Who Is on the Research Team?

Shuo Ma, MD, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01976520

NCT01976520 | Vaccine Therapy for Treating Patients With ... This Phase I trial studies the safety and efficacy of vaccine therapy in treating patients with previously untreated chronic lymphocytic leukemia.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01976520?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(CLL))&rank=10

Vaccine Therapy for Treating Patients With Previously ... This Phase I trial studies the safety and efficacy of vaccine therapy in treating patients with previously untreated chronic lymphocytic leukemia .

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11381404/

iVAC-XS15-CLL01: personalized multi-peptide vaccination in ... However, XS15-adjuvanted vaccines in cancer patients maintained strong T-cell responses for more than two years after just two doses (21). Even ...

4. withpower.com withpower.com/trial/phase-1-leukemia-9-2013-e8590

Cancer Vaccine for Chronic Lymphocytic Leukemia This trial studies a special vaccine made from a patient's own cancer cells and an immune booster to treat chronic lymphocytic leukemia.

5. mycancergenome.org mycancergenome.org/content/drugs/oncoquest-l-vaccine/

oncoquest-l vaccine An autologous chronic lymphocytic leukemia cancer vaccine consisting of patient-specific membrane proteins directly extracted from patient autologous tumor ...

6. xemebiopharma.com xemebiopharma.com/chronic-lymphocytic-leukemia

Chronic Lymphocytic Leukemia - XEME Biopharma Inc. The trial is designed to determine the safety and clinical outcome of patients vaccinated with Oncoquest™-CLL. ... Oncoquest™-CLL vaccine manufacturing. Patients ...