A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV)

NCT05809752 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: MCC-21262
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to learn about the effects of the study treatment, Dendritic Cell Vaccine (DCV), to find the highest dose of the study treatment that can be given safely to Breast Cancer patients with Leptomeningeal Disease

Conditions

Triple Negative Breast Cancer; HER2-positive Breast Cancer; Leptomeningeal Disease

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose of Intrathecal Dendritic Cell Vaccine

  Maximum tolerated dose of intrathecal dendritic cell vaccine is defined as the highest dose of vaccine that does not cause undesirable side effects/dose limiting toxicity (DLT). To evaluate safety, the study team will monitor toxicities continuously and the study will be halted if an excessive number of toxicities are encountered.

  Up to 12 weeks

Secondary Outcomes (2)

• Overall Survival

  Up to 12 months

• Progression Free Survival

  Up to 12 months

Study Arms (1)

Dendritic Cell (DC) Vaccine dose escalation

EXPERIMENTAL

HER2/3 peptide-pulsed DC1 will be administered intrathecally (IT) weekly for 6 doses /cycle for a maximum of two cycles, and then re-staged. If there are sufficient DC1s this may be continued weekly thereafter. There are 1 safety cohort (1 million DCV cells) and 3 escalating doses (2 million, 10 million and 50 million DCV cells) possible.

Biological: Dendritic Cell Vaccine

Interventions

Dendritic Cell Vaccine BIOLOGICAL

Intrathecal (IT) dendritic cell vaccine (DCV) will be administered once every week. As per standard procedures of IT chemotherapy or antibody administration it is administered over 5 -10 minutes or at 1 ml/minute while monitoring the patient under sterile conditions. In general, to assure delivery of the DCVs into the ventricular space and compensate for "dead space" in the Ommaya, the delivery of IT DCV cells is followed by the administration of 2.5 mls of saline. In general there is a maximum volume of 10 mls of DCVs.

Dendritic Cell (DC) Vaccine dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of TNBC or HER2+BC per ASCO/CAP guidelines . A tumor can be considered a TNBC if the ER or PR is \<10%.
• Patients must have an Eastern Cooperative Oncology Group performance scale of ≤ 3.
• Coincident Brain or Spinal cord metastases are allowed if these are stable and do not require local therapy at the time of enrollment. Individuals with previously treated stable Brain metastases are eligible to participate.
• Stereotactic Radiosurgery (SRS) and/or prior radiotherapy is permitted \> 2 weeks prior to initial Dendritic Cell (DC) vaccine dose. A follow up brain MRI should be obtained prior to DC vaccine to determine stability of the lesions. An interval of at least 4 weeks after the end of whole brain radiation or for any surgical resection of brain lesions is permitted.
• Life expectancy of ≥ 8 weeks.
• Demonstrate adequate organ function as defined in protocol. All screening labs should be performed with 14 days of treatment initiation.
• Provision of signed and dated informed consent form.
• Corticosteroids at doses equivalent to 8 mg dexamethasone daily for symptom control are acceptable. This should be minimized wherever possible.

You may not qualify if:

• Patients with systemic disease are eligible and will be managed as detailed in Section 6.3.1.
• Pregnancy test: negative serum or urine pregnancy test at screening for women of childbearing potential. Must be repeated once-monthly during treatment. Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 90 days after last treatment administration, if the risk of conception exists.
• The patient has an Ommaya reservoir or equivalent device which allows routine access to CSF and administration of DC1s.
• Receiving other treatments specifically administered to treat LMD within the last 2 weeks or 5 half-lives of the agent, whichever is less. However, all other treatments to control systemic disease or bulk CNS disease will be eligible, provided the therapy is not a phase I agent, an agent which significantly and unequivocally penetrates the CSF (e.g., high-dose methotrexate, thiotepa, high-dose ara-C) per PI discretion.
• The use of any immunotherapy within the last four weeks.
• Patients with a ventriculoperitoneal or ventriculoatrial shunt must have an on/off device in their shunt systems to be eligible for the study. Patients must be able to tolerate shunt closure for \~4 hours without development of clinical signs of increased intracranial pressure. Patients unable to tolerate shunt closure for \~4 hours will not be eligible for the study.
• Unable or unwilling to have a contrast-enhanced brain MRI.
• Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin,squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
• Has an active infection requiring systemic therapy which in the opinion of the investigator will increase the risk to the patient.
• Had major surgical procedure, or significant traumatic injury within two weeks. Ommaya placement is allowed.
• Has a history of current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 90 days after the last dose of trial treatment.
• Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1, 2 antibodies). Testing is not mandatory.
• Has known active or chronic hepatitis B (HBV) or hepatitis C virus (HCV). Testing is not mandatory.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• United States Department of Defense: collaborator

Study Sites (3)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

WITHDRAWN

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

WITHDRAWN

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Meningeal Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peter A Forsyth, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start: August 22, 2023
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (3)