Oncoquest-L Vaccine for Follicular Lymphoma

Overseen By Mittie Mitchell, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: XEME Biopharma Inc.

Must not be taking: Immunosuppressive therapy

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 19 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine treatment for individuals with Stage III or IV follicular lymphoma, a type of blood cancer. The Oncoquest-L vaccine aims to help the immune system recognize and destroy cancer cells by using a mix of the patient's own cancer cells and a protein called interleukin-2. The study will evaluate the treatment's effectiveness, safety, and the duration patients can go without needing further treatment. Individuals diagnosed with follicular lymphoma within the past year, who have not yet received treatment, and have a low burden of disease may be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on immunosuppressive therapy while participating.

Is there any evidence suggesting that the Oncoquest-L vaccine is likely to be safe for humans?

Research has shown that the Oncoquest-L vaccine has undergone testing in people. It was generally safe for patients with follicular lymphoma. In one study, 5 out of 10 patients had a positive immune response without serious side effects. Safety checks monitored vital signs such as blood pressure and heart rate, indicating the vaccine was well-tolerated by those patients. Although the vaccine remains under investigation and is not yet approved, earlier results suggest it could be a promising treatment for follicular lymphoma. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for follicular lymphoma, which often include chemotherapy and targeted therapies like rituximab, the Oncoquest-L vaccine offers a unique immunotherapy approach. This treatment is designed to stimulate the patient's immune system to recognize and attack cancer cells specifically. Researchers are excited about Oncoquest-L because it is administered subcutaneously at alternating sites, potentially enhancing its effectiveness and reducing systemic side effects. With its novel delivery and mechanism, Oncoquest-L could offer a more targeted and potentially less toxic option for patients.

What evidence suggests that the Oncoquest-L vaccine might be an effective treatment for follicular lymphoma?

Research has shown that the Oncoquest-L vaccine, which participants in this trial will receive, can help the immune system recognize and fight follicular lymphoma, a type of blood cancer. In one study, the vaccine was safe and helped the immune system attack the tumor in 5 out of 10 patients. After receiving the vaccine, the patients' immune systems began fighting the cancer cells. The goal is for this immune response to slow the cancer and delay the need for other treatments. The vaccine is made using a mix of the patient's own cancer cells and a protein called interleukin-2, which boosts the immune system. Early results are promising, suggesting the vaccine might work for some patients with follicular lymphoma. ^{1 4 5 6 7}

Who Is on the Research Team?

Brion Randolph, MD

Principal Investigator

Southeastern Regional Medical Center at Cancer Treatment Centers of America

Are You a Good Fit for This Trial?

This trial is for adults with a recent diagnosis of Stage III or IV follicular lymphoma, who haven't been treated yet. They should have low tumor burden, be in good physical condition, and not show severe symptoms. Pregnant women, those on immunosuppressants, or with active infections like HIV can't join.

Inclusion Criteria

My disease can be measured or evaluated after tissue collection for vaccine production.

I have a lymph node that is big enough and can be surgically removed for testing.

Fertile patients must use effective contraception during and for 12 months after completion of therapy

Exclusion Criteria

I do not have active HIV, hepatitis B, hepatitis C, or other infections.

Any medical or psychiatric condition that in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment

I haven't had cancer in the last 2 years, except for certain skin cancers or cervical cancer that were completely treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4-8 weeks

1 visit (in-person)

Treatment

Participants receive 5 doses of the Oncoquest-L vaccine, with the first 2 doses given at 2-week intervals and the remaining 3 doses at monthly intervals

19 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with imaging studies and response assessments every 3 months during the first year and every 6 months during the second year

Up to 2 years

Every 3 months in the 1st year, every 6 months in the 2nd year

What Are the Treatments Tested in This Trial?

Interventions

• Oncoquest-L vaccine

Trial Overview The Oncoquest-L vaccine is being tested to see if it helps the immune system fight cancer by using the patient's own cancer cells mixed with IL-2 protein. The study will check how well tumors respond and monitor safety and time until other treatments are needed.

How Is the Trial Designed?

Group I: Oncoquest-L vaccine Experimental Treatment 1 Intervention

Patients will receive a total of 5 single injections of Oncoquest-L; the first 2 doses administered will be separated by a 2-week interval and the remaining 3 doses will be administered each at 1-month intervals. With each dose of Oncoquest-L vaccine, the vaccine will be administered subcutaneously at 2 different sites in the upper arms or upper legs, with alternation of the injection sites with each administration.

Who Is Running the Clinical Trial?

XEME Biopharma Inc.

Lead Sponsor

Trials

2

Recruited

60+

Published Research Related to This Trial

In a study of 373 cancer patients under 65 years old who received COVID-19 vaccines, 76.1% experienced mild vaccine-related adverse events (VRAEs), with the most common being sore arm, fatigue, and headaches, indicating that the vaccines are generally well-tolerated in this population.

Only 2.1% of patients experienced grade 3 VRAEs, and there were no severe reactions (grade 4/5 or anaphylaxis), suggesting that COVID-19 vaccines have a favorable safety profile for patients undergoing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COVID-19 Vaccine Safety in Cancer Patients: A Single Centre Experience. So, ACP., McGrath, H., Ting, J., et al.[2021]

Tumor-specific vaccination strategies have been found to be generally safe in early clinical trials involving cancer patients, following promising results in preclinical mouse models.

The effectiveness of these vaccines is likely to be higher in patients with less advanced cancer, and there is a need for better methods to detect both natural and vaccine-induced T cell immunity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and evaluation of antigen-specific vaccination strategies against cancer. Offringa, R., van der Burg, SH., Ossendorp, F., et al.[2019]

Therapeutic vaccines targeting lymphoma have been developed to stimulate the immune system to fight tumors, primarily using the unique idiotype of tumor B cells as a specific antigen.

Recent phase III trials did not show improved progression-free survival after chemotherapy with these vaccines, but ongoing research is focused on enhancing their effectiveness through better antigen delivery and boosting T cell responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaccines for lymphomas: idiotype vaccines and beyond. Houot, R., Levy, R.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02194751

Study Details | NCT02194751 | Oncoquest-L Vaccine in ... This Phase II trial studies the overall tumor response of vaccine therapy in patientswith previously untreated Stage III or IV, asymptomatic, ...

2. withpower.com withpower.com/trial/phase-3-lymphoma-6-2021-2343d

Oncoquest-L Vaccine for Follicular Lymphoma This trial is for adults with a recent diagnosis of Stage III or IV follicular lymphoma, who haven't been treated yet. They should have low tumor burden, be in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7926563/

Targeted Treatment of Follicular Lymphoma - PMC Indeed, a CR rate of 92%, with an estimated median 2-year PFS of 96% was reported with obinutuzumab-lenalidomide in the upfront setting [22].

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

oncoquest-l vaccine Of the trial investigating oncoquest-l vaccine, 1 is phase 2 (1 open). Follicular lymphoma is the most common disease being investigated in oncoquest-l vaccine ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1941785/

A novel proteoliposomal vaccine induces antitumor ... Vaccination was safe, induced autologous tumor-specific type 1 cytokine responses in 5 out of 10 follicular lymphoma patients, and was associated with induction ...

6. clin.larvol.com clin.larvol.com/trial-detail/NCT02194751

Oncoquest-L Vaccine in Patients With Previously Untreated ... Safety evaluation will include frequency, severity, and relationship of adverse events to vaccination; vital signs (blood pressure, respiration, pulse, and ...

7. adisinsight.springer.com adisinsight.springer.com/trials/700247741

Oncoquest-L Vaccine in Patients With Previously Untreated ... This trial studies the overall tumour response of vaccine therapy in patients with previously untreated stage III or IV, asymptomatic, ...