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

30 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the Oncoquest-L treatment for follicular lymphoma?

Research on similar idiotype vaccines for follicular lymphoma shows that they can trigger immune responses against the tumor, with some early trials indicating safety and potential clinical activity. Although some large trials did not meet their main goals, they still offer hope for future improvements in vaccine strategies. ^{1 2 3 4 5}

Is the Oncoquest-L vaccine generally safe for humans?

The BLP25 liposome vaccine, which may be similar to Oncoquest-L, was tested in patients with lung cancer and showed no serious side effects, with mild issues like muscle pain and nausea. This suggests it is generally safe in humans. ^{6 7 8 9 10}

How is the Oncoquest-L vaccine treatment different from other treatments for follicular lymphoma?

The Oncoquest-L vaccine is unique because it uses the tumor-specific idiotype (a unique part of the cancer cell's surface) to stimulate the immune system to target and fight the lymphoma. This approach is different from standard treatments as it aims to create a personalized immune response against the cancer, potentially offering a more targeted and less toxic option. ^{1 2 3 4 5}

What is the purpose of this trial?

This Phase II trial studies the overall tumor response of vaccine therapy in patientswith previously untreated Stage III or IV, asymptomatic, non-bulky follicular lymphoma. The vaccine contains an extract of the patient's own cancer cells and the immunostimulant protein, interleukin-2 (IL-2). It is hoped that when injected under the skin, the vaccine will enable the patient's immune system to recognize and destroy the cancer cells. The trial will also assess the safety of the vaccine, the time from vaccine treatment until the patient requires another type of anti-lymphoma treatment, progression-free survival, and the anti-tumor immune response.

Research Team

Brion Randolph, MD

Principal Investigator

Southeastern Regional Medical Center at Cancer Treatment Centers of America

Eligibility Criteria

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

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

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

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

Exclusion Criteria

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Role of anti-idiotype vaccines in the modern treatment of human follicular lymphoma. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Vaccination strategies in follicular lymphoma. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Idiotype vaccine strategies for treatment of follicular lymphoma. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Recombinant, tumour-derived idiotype vaccination for indolent B cell non-Hodgkin's lymphomas: a focus on FavId. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Vaccines for lymphomas: idiotype vaccines and beyond. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

COVID-19 Vaccine Safety in Cancer Patients: A Single Centre Experience. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Safety of BLP25 liposome vaccine (L-BLP25) in Japanese patients with unresectable stage III NSCLC after primary chemoradiotherapy: preliminary results from a Phase I/II study. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

COVID-19 Vaccines in Cancer Patients. Seropositivity and Safety. Systematic Review and Meta-Analysis. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Design and evaluation of antigen-specific vaccination strategies against cancer. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Safety of COVID-19 Vaccine in Patients with Cancer in a High-Volume Comprehensive Cancer Center. [2022]