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Trial Title:
Personalized Dendritic Cell Vaccine Pilot for High Risk TNBC After Neoadjuvant Therapy
NCT ID:
NCT06435351
Condition:
Breast Cancer
Triple Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Leukapheresis
Description:
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.
Arm group label:
Dendritic Cell (DC) Vaccine
Intervention type:
Biological
Intervention name:
Dendritic Cell (DC) Vaccine
Description:
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.
Arm group label:
Dendritic Cell (DC) Vaccine
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patient has stage II-III ER/PR less than or equal to 10% HER2 negative by FISH
and/or IHC breast cancer treated with standard of care neoadjuvant systemic
chemotherapy and surgical resection with significant residual breast tumor
(equivalent to RCB II or III) disease.
- Patient has sufficient residual viable primary breast tumor or ipsilateral breast
axillary nodal metastatic cancer tissue accessible to Moffitt for whole exome
sequencing.
- Patient is 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Patients must have adequate organ and marrow function.
- Patients with a prior or concurrent malignancy whose natural history or treatment
does not have the potential to interfere with the safety or efficacy assessment of
the investigational regimen are eligible for this trial.
- Patients without radiologic evidence of active metastatic disease and who are within
18 months of their last dose curative intent chemotherapy and/or radiotherapy
(whichever is later) for the purposes of study enrollment.
- Women of child-bearing potential must agree to use adequate contraception (hormonal
or barrier method of birth control; abstinence) prior to study entry and for the
duration of study participation. Should a woman become pregnant or suspect she is
pregnant while she or her partner is participating in this study, she should inform
her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent
document.
Exclusion Criteria:
- Patients with known active locally advanced unresectable or metastatic cancer.
- Patients with significant uncontrolled intercurrent illness or autoimmune disease
requiring systemic immunosuppressants that would be deemed unsuitable to participate
in the study by the Principal Investigator (PI).
- Patients who have a medical issue in the opinion of the treating physician and/or PI
that would make them unsuitable for pheresis.
- Patients who are currently receiving any other investigational agents.
- Patients with psychiatric illness/social situations that would limit compliance with
study requirements.
- Pregnant women are excluded from this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Neveen Abdo
Phone:
813-745-4412
Email:
neveen.abdo@moffitt.org
Contact backup:
Last name:
Hatem Soliman, MD
Investigator:
Last name:
Hatem Soliman, MD
Email:
Principal Investigator
Investigator:
Last name:
Mohammed Al-Jumayl
Email:
Sub-Investigator
Investigator:
Last name:
Avan Armaghani
Email:
Sub-Investigator
Investigator:
Last name:
Ricardo Costa
Email:
Sub-Investigator
Investigator:
Last name:
Martine Extermann
Email:
Sub-Investigator
Investigator:
Last name:
Heather Han
Email:
Sub-Investigator
Investigator:
Last name:
Susan Hoover
Email:
Sub-Investigator
Investigator:
Last name:
Nazanin Khakpour
Email:
Sub-Investigator
Investigator:
Last name:
John Kiluk
Email:
Sub-Investigator
Investigator:
Last name:
Laura Kruper
Email:
Sub-Investigator
Investigator:
Last name:
Marie Lee
Email:
Sub-Investigator
Investigator:
Last name:
Loretta Loftus
Email:
Sub-Investigator
Investigator:
Last name:
Tracey O'Connor
Email:
Sub-Investigator
Investigator:
Last name:
Christine Sam
Email:
Sub-Investigator
Investigator:
Last name:
Aixa Soyano Muller
Email:
Sub-Investigator
Investigator:
Last name:
Brian Czerniecki
Email:
Sub-Investigator
Investigator:
Last name:
Kimberly Lee
Email:
Sub-Investigator
Start date:
June 12, 2024
Completion date:
May 2029
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06435351
http://www.moffitt.org/clinical-trials-research/clinical-trials/
