Personalized Dendritic Cell Vaccine Pilot for High Risk TNBC After Neoadjuvant Therapy

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06435351
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Leukapheresis — PROCEDURE
    Removal of white blood cells (leukocytes) from the blood. The dendritic cells are harvested from the white blood cells that are collected and trained to recognize the specific abnormal proteins found in the tumor sample. One needle is inserted in each arm. An apheresis machine removes blood from the vein in one arm, separates and retains the leukocytes from the blood, and then returns the rest of the blood to the other arm.
  • Dendritic Cell (DC) Vaccine — BIOLOGICAL
    The vaccine will be given intranodally (inguinal or axillary) under ultrasound guidance using a dose of 40-50 million cells three times spaced 2 weeks apart for the initial priming sequence. 3 doses of the priming vaccines are given once every 2 weeks. 2 booster shots (if available) will be given 6 months and 12 months following completion of initial priming vaccines.

Study Details

This is a pilot protocol to evaluate the safety, feasibility, and immunogenicity of a personalized breast cancer vaccine based utilizing whole exome sequencing data of a patient's residual breast tumor following neoadjuvant chemotherapy.

Key Dates

Start date
Jun 12, 2024
Status verified
Mar 2026
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dendritic Cell (DC) Vaccine
    The tumor specimen collected from the primary tumor will undergo whole exome sequencing (WES). The WES data will be analyzed to select up to 20 neoantigens. From this screen up to 10 peptides will be selected to be synthesized for testing and use on the DC pheresis product that will be collected. The ready vaccine product will be cryopreserved and then thawed once the patient is ready to under the vaccination sequence.

Primary Outcome Measure

Percentage of patients enrolled who successfully undergo at least one vaccination. [ Time Frame: Up to 3 Years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Neveen Abdo
[email protected]
813-745-4412
Hatem Soliman, MD
Hatem Soliman, MD (PRINCIPAL_INVESTIGATOR)
Mohammed Al-Jumayl (SUB_INVESTIGATOR)
Avan Armaghani (SUB_INVESTIGATOR)
Ricardo Costa (SUB_INVESTIGATOR)
Martine Extermann (SUB_INVESTIGATOR)
Heather Han (SUB_INVESTIGATOR)
Susan Hoover (SUB_INVESTIGATOR)
Nazanin Khakpour (SUB_INVESTIGATOR)
John Kiluk (SUB_INVESTIGATOR)
Laura Kruper (SUB_INVESTIGATOR)
Marie Lee (SUB_INVESTIGATOR)
Loretta Loftus (SUB_INVESTIGATOR)
Tracey O'Connor (SUB_INVESTIGATOR)
Christine Sam (SUB_INVESTIGATOR)
Aixa Soyano Muller (SUB_INVESTIGATOR)
Brian Czerniecki (SUB_INVESTIGATOR)
Kimberly Lee (SUB_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Moffitt Cancer Center· Tampa, FL

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