Evidence map›Paper›PMID 39165083›Full record

Trial reportHuman vaccines & immunotherapeutics2024

Results of a phase I/IIa trial of SV-BR-1-GM inoculation with low-dose cyclophosphamide and interferon alpha (Bria-IMT) in metastatic breast cancer.

Charles L Wiseman, Jarrod P Holmes, Carmen Calfa, Shaker R Dakhil, Saveri Bhattacharya, George E Peoples, Markus D Lacher, Miguel Lopez-Lago, Alex Kharazi, Giuseppe Del Priore and 3 more

Abstract readClinical Trial, Phase IIClinical Trial, Phase IMulticenter Study
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Immunotherapy in Breast Cancer: Beyond Immune Checkpoint Inhibitors.International journal of molecular sciences · 2025
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Charles L WisemanDevelopment, BriaCell Therapeutics Corp, Philadelphia, PA, USA.
Jarrod P HolmesHematology Oncology, Providence Medical Group Santa Rosa - Cancer Center, Santa Rosa, CA, USA.
Carmen CalfaMedical Oncology, University of Miami, Miami, FL, USA.
Shaker R DakhilMedical Oncology, Cancer Center of Kansas, Wichita, KS, USA.
Saveri BhattacharyaAbramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.
George E PeoplesOncology, Lumabridge, San Antonio, TX, USA.
Markus D LacherDevelopment, BriaCell Therapeutics Corp, Philadelphia, PA, USA.ORCID 0000-0003-2597-5704
Miguel Lopez-LagoDevelopment, BriaCell Therapeutics Corp, Philadelphia, PA, USA.
Alex KharaziDevelopment, BriaCell Therapeutics Corp, Philadelphia, PA, USA.
Giuseppe Del PrioreDevelopment, BriaCell Therapeutics Corp, Philadelphia, PA, USA.
Mingjin ChangDevelopment, BriaCell Therapeutics Corp, Philadelphia, PA, USA.
Daniel L AdamsDiscovery, Creatv MicroTech, Inc., Rockville, MD, USA.ORCID 0000-0002-1916-9637
William V WilliamsDevelopment, BriaCell Therapeutics Corp, Philadelphia, PA, USA.ORCID 0000-0003-3611-9284

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This Phase I/IIa open-label, single-arm clinical trial addressing advanced, refractory, metastatic breast cancer was conducted at six medical centers in the United States. We repeated inoculations with irradiated SV-BR-1-GM, a breast cancer cell line with antigen-presenting activity engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), with pre-dose low-dose cyclophosphamide and post-dose local interferon alpha. Twenty-six patients were enrolled; 23 (88.5%) were inoculated, receiving a total of 79 inoculations. There were six Grade 4 and one Grade 5 adverse events noted (judged unrelated to SV-BR-1-GM). Disease control (stable disease [SD]) occurred in 8 of 16 evaluable patients; 4 showed objective regression of metastases, including 1 patient with near-complete regressions in 20 of 20 pulmonary lesions. All patients with regressions had human leukocyte antigen (HLA) matches with SV-BR-1-GM; non-responders were equally divided between matching and nonmatching (

Indexed as

Breast NeoplasmsCyclophosphamideGranulocyte-Macrophage Colony-Stimulating FactorInterferon-alphaAdultAgedCell Line, TumorFemaleHumansMiddle AgedNeoplasm MetastasisTreatment OutcomeUnited StatesCyclophosphamideGranulocyte-Macrophage Colony-Stimulating FactorInterferon-alphabreast cancerhistocompatibility markersimmunotherapyNCT03066947SV-BR-1-GMtherapeutic cancer vaccineTrial registration

Identifiers

PMID39165083
PMCPMC11340742

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.