What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as proteasome inhibitors (e.g., bortezomib), immunomodulatory drugs (e.g., lenalidomide), and monoclonal antibodies (e.g., daratumumab), often have side effects that include increased risk of infections, neutropenia, gastrointestinal issues, fatigue, and infusion reactions. Specifically, proteasome inhibitors can lead to herpes zoster reactivation, while immunomodulatory drugs are associated with higher rates of severe infections and secondary malignancies. Monoclonal antibodies may cause infusion-related reactions and respiratory infections. These side effects reflect the immune-modulating nature of these therapies, similar to the dendritic cell-based treatments being studied.

What prior FDA approvals exist?

FDA-approved treatments for multiple myeloma that enhance the immune response include monoclonal antibodies like daratumumab, which targets the CD38 antigen on myeloma cells. Daratumumab has shown significant efficacy both as a monotherapy and in combination with other drugs. Other immunotherapies include elotuzumab, which targets SLAMF7, and is used in combination with lenalidomide and dexamethasone. These treatments work by enhancing the body's immune response to target and kill myeloma cells, similar to the investigational approach of using ex vivo generated dendritic cells to boost immune activity.

What other types of research exist?

Promising novel alternatives to Ex Vivo Generated Dendritic Cells (HDC) Infusion for Multiple Myeloma patients include: 1) Daratumumab, a monoclonal antibody targeting CD38, which has shown efficacy in combination with other agents like bortezomib, thalidomide, and dexamethasone (DVTd). 2) Lenalidomide-based regimens, which are immunomodulatory and have demonstrated durable hematologic responses. 3) Proteasome inhibitor-based regimens, such as those including bortezomib, which are effective in relapsed or refractory cases. These alternatives offer various mechanisms to enhance immune response and improve clinical outcomes.

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Cancer Vaccine

Host Dendritic Cell Therapy for Lymphoma

Phase 1

Waitlist Available

Led By Keren Osman, M.D.

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

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

Must have

ECOG performance status ≤3

Adequate pulmonary function with DLCO > 50%

Must not have

Prior allogeneic stem cell transplant

Concurrent illnesses that would preclude survival > 6 months other than the disease under study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing a treatment where special immune cells are grown outside the body and given to patients who had a stem cell transplant. Sometimes, extra immune cells from a donor are also given. The goal is to help the patient's immune system get stronger and better at fighting diseases.

Who is the study for?

This trial is for adults aged 18-70 with certain blood cancers like Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia who are eligible for a stem cell transplant. Participants must have good heart, lung, liver and kidney function and not be pregnant or nursing. They should agree to use birth control and cannot have had prior treatments that might interfere with the study.

What is being tested?

The trial is testing the safety and effectiveness of a vaccine made from dendritic cells (HDC Vax-001) in patients after they've received an allogeneic stem cell transplant. Some participants will also receive donor lymphocyte infusions. The process involves shipping collected immune cells to create the vaccine which is then returned for patient treatment.

What are the potential side effects?

Potential side effects aren't specified but may include typical reactions related to immune system stimulation such as fever, fatigue or pain at injection site; organ inflammation due to immune response; or complications from donor lymphocyte infusion.

Eligibility Criteria

Inclusion Criteria

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

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I am capable of limited self-care.

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My lung function is more than half of what is considered normal.

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My liver is functioning within the required limits.

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My kidneys are working well.

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I am between 18 and 70 years old.

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I have a specific type of blood cancer and am eligible for a stem cell transplant.

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My heart pumps well, with an ejection fraction over 50%.

Exclusion Criteria

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

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I have had a stem cell transplant from a donor.

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I do not have any illnesses that would shorten my life to less than 6 months, aside from my current condition.

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I have a history of autoimmune diseases like lupus, rheumatoid arthritis, or thyroiditis.

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I do not have any active infections, including fungal or hepatitis.

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My skin condition after a transplant is worse than mild.

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I haven't received chemotherapy in the last 4 weeks.

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I have received a donor lymphocyte infusion before.

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I am HIV positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment1 Intervention

Patients with greater than Minimal Residual Disease or Minimal Volume Relapse post allogeneic stem cell transplant will receive MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) by infusion in conjunction with donor lymphocyte infusion (DLI)

Group II: Group 1Experimental Treatment1 Intervention

Patients with Minimal Residual Disease or Minimal Volume Relapse post allogeneic stem cell transplant will receive MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) by infusion

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Myeloma treatments often target the immune system to enhance its ability to fight cancer cells. Dendritic cell vaccines, like the ex vivo generated dendritic cells (HDC) infusion, work by stimulating the patient's immune system to recognize and attack myeloma cells. These vaccines are created by exposing dendritic cells to myeloma antigens outside the body and then reintroducing them to the patient, thereby enhancing the immune response. Other common treatments include monoclonal antibodies (e.g., daratumumab) that target specific proteins on myeloma cells, proteasome inhibitors (e.g., bortezomib) that disrupt protein degradation in cancer cells, and immunomodulatory drugs (e.g., lenalidomide) that boost the immune system and inhibit myeloma cell growth. These treatments are crucial for Multiple Myeloma patients as they offer targeted approaches to control the disease, improve survival rates, and maintain quality of life.

Dendritic cell vaccines for the treatment of prostate cancer.

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Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

886 Previous Clinical Trials

535,018 Total Patients Enrolled

Keren Osman, M.D.Principal InvestigatorIcahn School of Medicine at Mount Sinai

Media Library

MSSM/BIIR HDC Vax-001 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT00935597 — Phase 1

Hodgkin's Lymphoma Research Study Groups: Group 1, Group 2

Hodgkin's Lymphoma Clinical Trial 2023: MSSM/BIIR HDC Vax-001 Highlights & Side Effects. Trial Name: NCT00935597 — Phase 1

MSSM/BIIR HDC Vax-001 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00935597 — Phase 1

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