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

9 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of vaccine therapy in treating patients with lymphoplasmacytic lymphoma. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells.

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 the Vaccine Therapy for Lymphoma safe for humans?

In a clinical trial with 12 patients who received the DNA vaccine for B-cell lymphoma, no significant side effects or toxicities were observed, suggesting it is generally safe in humans. ^{1 2 3 4 5}

How does the treatment Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine differ from other treatments for lymphoma?

This treatment is unique because it combines a part of the tumor's own protein with a chemokine (a signaling protein that attracts immune cells) to create a vaccine that specifically targets and activates the immune system against the tumor, offering a more personalized and potentially more effective approach compared to traditional protein vaccines. ^{4 6 7 8 9}

What data supports the effectiveness of the treatment Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine for lymphoma?

Research shows that fusing a tumor antigen with a chemokine (a type of signaling protein) can create a vaccine that triggers a strong immune response against tumors. This approach has been more effective than other protein vaccines in protecting against large tumor challenges in experimental models. ^{6 8 9 10 11}

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

Genetic fusion of chemokines to a self tumor antigen induces protective, T-cell dependent antitumor immunity. [2020]

2. China pubmed.ncbi.nlm.nih.gov

[Construction of a DNA vaccine against human B cell lymphoma]. [2007]

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

Vaccination with patient-specific tumor-derived antigen in first remission improves disease-free survival in follicular lymphoma. [2023]

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

A genetic approach to idiotypic vaccination for B cell lymphoma. [2019]

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

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

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

Genetic immunization with CDR3-based fusion vaccine confers protection and long-term tumor-free survival in a mouse model of lymphoma. [2021]

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

Immunogenicity of a plasmid DNA vaccine encoding chimeric idiotype in patients with B-cell lymphoma. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Insight into the potential for DNA idiotypic fusion vaccines designed for patients by analysing xenogeneic anti-idiotypic antibody responses. [2019]

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

Models for lymphoma. [2022]

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

A nine-amino acid peptide from IL-1beta augments antitumor immune responses induced by protein and DNA vaccines. [2020]

11. China pubmed.ncbi.nlm.nih.gov

[Development of IgHV family specific nucleic acid vaccine against lymphoma by construction of fusion gene of immunoglobulin heavy chain variable region and cytokine]. [2011]