Vaccine Therapy for Lymphoma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: HIV, Hepatitis B/C, Pregnancy, others

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

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new vaccine therapy, the Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine, to determine the optimal dose and understand its side effects in treating lymphoplasmacytic lymphoma, a cancer affecting the blood and bone marrow. The vaccine aims to help the immune system target and kill cancer cells. Individuals with this lymphoma who have not received prior treatment and are currently asymptomatic might be suitable for the trial. Participants will receive the vaccine at specific intervals over several months. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that the vaccine treatment tested in this trial appears safe. In a study with 12 patients with B-cell lymphoma, those who received the DNA vaccine experienced no major side effects or harmful reactions, indicating that the treatment is well-tolerated.

This vaccine, made from a person's own cancer cells, is designed to help the immune system fight cancer. Although still in the early stages of testing, the initial results are promising for potential trial participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for lymphoma, which often include chemotherapy and monoclonal antibodies, this vaccine therapy uses a unique approach. It utilizes an autologous lymphoma immunoglobulin-derived single-chain variable fragment (scFv) combined with a chemokine in a DNA vaccine. This means that the vaccine is personalized, using specific components from the patient's own cancer cells to help the immune system recognize and attack the lymphoma more effectively. Researchers are excited about this treatment because it has the potential to enhance the body's natural immune response, offering a more targeted and possibly less toxic alternative to traditional therapies.

What evidence suggests that this vaccine therapy could be effective for lymphoma?

Research has shown that a new personalized vaccine, administered to participants in this trial, might offer a promising treatment for lymphoma. This vaccine uses a part of the patient's own cancer cells to help the immune system recognize and attack the cancer. Early studies suggest that this personalized approach can enhance the body's immune response against cancer cells. While detailed results on its effectiveness are still being gathered, the method targets the body's natural defenses. Initial findings are hopeful, indicating potential for slowing cancer cell growth. ^{1 2 3 4 6}

Who Is on the Research Team?

Sheeba Thomas, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with lymphoplasmacytic lymphoma who haven't been treated before. They need a specific type of tumor sample, normal liver function tests, and no severe heart or autoimmune diseases. Participants must be able to consent and follow up, have good physical functioning, and use birth control if necessary.

Inclusion Criteria

My total bilirubin level is 1.5 mg/dl or lower, unless due to Gilbert's disease.

My lymphoma diagnosis was confirmed with specific tests for IgG, IgA, or IgM.

I am a woman who is either post-menopausal, surgically sterilized, or will use birth control during and 30 days after the study.

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 have positive ANA or anti-dsDNA antibodies.

You have HIV, hepatitis B, or hepatitis C infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive autologous lymphoma immunoglobulin-derived scFV-chemokine DNA vaccine intradermally at 0, 4, and 8 weeks

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Long-term follow-up

Participants are followed up every 6 months for 1 year to monitor long-term effects

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine

Trial Overview The study is testing a vaccine made from the patient's own cancer cells to see if it can trigger the body's immune system to fight the cancer. It also involves checking biomarkers in the lab to understand how well the vaccine works.

How Is the Trial Designed?

Group I: Treatment (vaccine therapy) Experimental Treatment 2 Interventions

Patients receive autologous lymphoma immunoglobulin-derived scFV-chemokine DNA vaccine ID at 0, 4, and 8 weeks.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Combining cancer vaccines with autologous stem cell transplantation (PSCT) may help eliminate minimal residual disease in lymphoma patients, addressing the significant issue of relapse after high-dose therapy.

Preclinical studies have shown that vaccination with patient-specific immunoglobulin idiotype can effectively enhance T-cell responses when used alongside marrow transplantation, paving the way for ongoing clinical trials in human patients with B-cell malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor vaccination strategies combined with autologous peripheral stem cell transplantation. Kwak, LW.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5812202/

Phase I study of an active immunotherapy for asymptomatic ... We are evaluating the safety of this next-generation DNA vaccine in a first-in-human clinical trial currently enrolling asymptomatic LPL patients.

2. cancer.gov cancer.gov/publications/dictionaries/cancer-drug/def/autologous-lymphoma-immunoglobulin-derived-scfv-chemokine-dna-vaccine

autologous lymphoma immunoglobulin-derived scFV- ... A plasmid DNA vaccine encoding an autologous lymphoma-derived idiotype-targeting immunoglobulin (Ig)-derived single chain variable fragment (scFv)

3. nature.com nature.com/articles/s41467-024-50880-2

Personalized neoantigen vaccines as early intervention in ... Here we report on a first-in-human clinical trial of a DNA vaccine, encoding the autologous LPL-derived Ig single chain variable fragment (scFv) ...

4. withpower.com withpower.com/trial/phase-1-lymphoma-1-2015-af447

Vaccine Therapy for Lymphoma · Info for Participants What data supports the effectiveness of the treatment Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine for lymphoma? Research shows that ...

5. trial.medpath.com trial.medpath.com/clinical-trial/917fcfb254c1d226/nct01209871-active-immunotherapy-lymphoplasmacytic-lymphoma-dna-vaccines

Vaccine Therapy in Treating Patients With Lymphoplasmacytic ... Patients receive autologous lymphoma immunoglobulin-derived scFV-chemokine DNA vaccine ID at 0, 4, and 8 weeks. Toxicity type and severity will be summarized ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2628002/

Therapeutic Vaccine for Lymphoma - PMC - PubMed Central Therapeutic vaccines targeting the tumor-specific idiotype have demonstrated promising results against lymphomas in phase I/II studies and are currently being ...