Trial · NCT02240537
Phase I Study of an Oncofetal Antigen Multi-Peptide Immunotherapy in Subjects With Hematologic Cancer
NCT02240537, Phase 1, Unknown, Benovus Bio, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I Study of an Oncofetal Antigen Multi-Peptide Immunotherapy in Subjects With Hematologic Cancer. Trials, record NCT02240537. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02240537
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I Study of an Oncofetal Antigen Multi-Peptide Immunotherapy in Subjects With Hematologic Cancer
- NCT number
- NCT02240537
- Status
- Unknown
- Phases
- Phase 1
- Enrollment
- 4 participants, actual
- Lead sponsor
- Benovus Bio, Inc.
- Conditions
- Acute Myelogenous Leukemia (AML), Multiple Myeloma (MM), Myelodysplastic Syndrome (MDS), Smoldering Multiple Myeloma (sMM)
- Interventions
- Sargramostim, BB-MPI-03, Montanide
- First posted
- 2014-09-15
- Last updated
- 2016-04-19
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determine the safety, dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and optimal biologic dose (OBD) of BB-MPI-03 and adjuvants in subjects with hematologic cancers who are off treatment and with stable disease (SD) or better. | 6 months treatment, 6 months follow-up | The safety and tolerability of BB-MPI-03 in Montanide emulsion preceded by sargramostim will be measured by: * The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs), DLTs, and AEs leading to study vaccine discontinuation. * The proportion of subjects requiring a modification of the study treatment dose or schedule. * Change from baseline in absolute neutrophil counts (ANC) and platelet counts. * The proportion of subjects with local injection site reactivity. * Proportion of subjects experiencing infections or fevers requiring hospitalization and/or intravenous (IV) antibiotics. |
| Secondary | Determine the in vivo cellular immune response profile of BB-MPI-03 and adjuvants in subjects who receive 5 and 6 intradermal (ID) injections over a 6- month period. | 12 Months | Immunologic responses (change from Baseline) will be assessed by: * DTH reaction to the peptides, as measured and photographed at 7 months using the "ballpoint pen" method. * Peptide-specific T-cell proliferation to ELISPOT and tetramer assay. * Level of OFA expression on tumor cells at Month 7. * Anti-peptide (anti-OFA) antibodies in the serum. These parameters will be measured at D15, D29, M2, M3, M6, M9, and M12 and compared to pre-treatment Baseline. DTH reaction to the peptides and OFA expression will be measured and recorded at 1 month after the last injection (M7). |
| Secondary | Evaluate any anti-tumor activity of BB-MPI-03 and adjuvants as assessed by disease reduction and lack of disease progression during and after treatment. | 12 Months | The anti-tumor activity of BB MPI 03 in Montanide emulsion preceded by sargramostim will be measured by: Time to progression (TTP) Overall response rate at Month 7 Best Overall Response |
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/NCT02240537
GET https://conductscience.org/api/trials/v1/NCT02240537/registered