Trial · NCT05378464
Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer
NCT05378464, Phase 1, Suspended, H. Lee Moffitt Cancer Center and Research Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer. Trials, record NCT05378464. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05378464
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer
- NCT number
- NCT05378464
- Status
- Suspended
- Phases
- Phase 1
- Enrollment
- 28 participants, estimated
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- HER2-positive Breast Cancer
- Interventions
- Dendritic Cell (DC1) Vaccine, Trastuzumab, Pepinemab, T-Cell therapy
- First posted
- 2022-05-18
- Last updated
- 2026-09-15
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of expanded CD4 T cells | Up to 6 months | MTD of expanded CD4 T cells after treatment with DC1 vaccines and trastuzumab/pepinemab. |
| Secondary | Overall Response Rate (ORR) | Up to 6 months | ORR according to RECIST criteria v1.1 and iRECIST of treatment DC1 vaccines and pepinemab/trastuzumab |
| Secondary | Clinical Benefit Rate (CBR) of DC1 vaccines and pepinemab/trastuzumab | at 6 months | To assess the 6-month clinical benefit rate (CBR) according to RECIST criteria v. 1.1 of treatment with DC1 vaccines and pepinemab/trastuzumab |
| Secondary | Clinical Benefit Rate (CBR) of expanded CD4 T Cells | at 6 months | To assess the 6-month CBR according to RECIST criteria v. 1.1 of treatment with expanded CD4+ T cells following DC1 vaccines and pepinemab/trastuzumab. |
| Secondary | Progression Free Survival (PFS) | Up to 36 months | PFS is defined as the length of time from start of treatment to progression or death. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05378464
GET https://conductscience.org/api/trials/v1/NCT05378464/registered