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Cancer Vaccine

Oncoquest-L Vaccine for Follicular Lymphoma

Phase 2

Waitlist Available

Led By Brion Randolph, MD

Research Sponsored by XEME Biopharma Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A single peripheral lymph node of at least 1 x 1 cm in size accessible for excisional biopsy

Measurable or evaluable disease after obtaining tissue for vaccine production

Must not have

Active HIV, hepatitis B, hepatitis C or other active infectious process

Concurrent treatment with immunosuppressive therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a vaccine made from a patient's own cancer cells and interleukin-2, given under the skin, to see if it can help the patient's immune system destroy the cancer cells.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, vaccines like this could cause reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, muscle aches or possibly allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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My condition is Stage III or IV follicular lymphoma and I haven't received treatment.

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I am fully active or can carry out light work.

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My condition does not cause me severe itching or B symptoms like fever.

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I am a woman able to have children and my pregnancy test before joining the study was negative.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am currently on immunosuppressive therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall tumor response rate

Secondary study objectives

Assessment of complete and partial tumor response rates

Safety evaluation will include frequency, severity, and relationship of adverse events to vaccination; vital signs (blood pressure, respiration, pulse, and temperature); and laboratory test results (including, hematology and clinical chemistry)

Tests to measure tumor-specific antibody production and T cell and B cell responses to vaccination

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Oncoquest-L vaccineExperimental Treatment1 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.

0 / 9Eligibility criteria met