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Acute Myelogenous Leukemia (AML)Phase 1BBMPI03NCT02240537

Phase I Study of an Oncofetal Antigen Multi-Peptide Immunotherapy in Subjects With Hematologic Cancer

A Phase 1 study testing Sargramostim, BB-MPI-03 and Montanide in people with Acute Myelogenous Leukemia (AML) and Multiple Myeloma (MM), run by Benovus Bio, Inc. at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study is designed to evaluate safety, immunogenicity, and preliminary anti-tumor activity of a multi-peptide immunotherapy (BB-MPI-03) at three peptide+adjuvant dose levels. The peptides stimulate cytotoxic T-cells targeting oncofetal antigen (OFA). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sargramostim, BB-MPI-03 and Montanide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
3 sitesUnited States
Study dates
Jan 2015to Jun 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • History of morphologically confirmed AML w/ classification other than WHO Acute Promyelocytic Leukemia (FAB M3), based on bone marrow examination.
  • not a candidate for allogeneic HSCT or no intention to move to HSCT at time of enrollment.
  • Patient's AML could be in morphologic CR or no further cytotoxic chemotherapy is currently being considered.
  • Completed consolidation chemotherapy, if available and/or appropriate for patient.
  • Can have history of allogeneic HSCT transplant, but must be off immunosuppression for at least 2 wks. before enrollment and w/o GVHD and/or toxicities from HSCT.
  • Diagnosed in past 5 years w/ smoldering MM at high risk of progressing to symptomatic MM.
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  • Diagnosis defined as: Bone marrow infiltration with plasma cells (PCs) ≥10% and presence of a monoclonal component, Ig G ≥3 g/dl or IgA ≥2 g/dl or Bence-Jones proteinuria >1 g/dl and absence of lytic lesions on skeletal survey, absence of hypercalcemia (corrected calcium <11 mg/dl), absence of renal failure (creatinine ≤1.5 x ULN), and absence of anemia (hemoglobin >10 g/dl or not 2 g/dl below LLN).
  • Must meet one of following:
  • ≥10% PCs in bone marrow and IgG ≥3 g/dl or IgA ≥2 g/dl,
  • ≥10% PCs in bone marrow and serum FLC ratio (involved : uninvolved) >100 in blood, or
  • IgG ≥3 g/dl or IgA ≥2 g/dl and FLC ratio (involved: uninvolved) >100 in blood. c. MM post-treatment disease that is clinically stable and does not require treatment at least 4 weeks prior to enrollment.
  • At least one line of treatment and achieved at least PR by IMWG ii. Stable disease or better per IMWG based on 2 subsequent assessments at least one month apart d. history of morphologically confirmed MDS i. previously received at least one treatment for MDS, including but not limited to chemotherapy or hypomethylating agent(s). Subjects may be previously untreated if they refuse treatment with or are not appropriate candidates for chemotherapy or hypomethylating agent(s) in the investigator's opinion.
  • intermediate, high, or very high risk MDS by IPSS-r iii. No curative intent option of allogeneic HSCT or refused consideration for allogeneic HSCT iv. Could have history of allogeneic HSCT transplant and relapsed, but must be off immunosuppression for at least 2 weeks before enrollment and without GVHD and/or toxicities from HSCT.
  • 2. Low, moderate, to high levels of OFA expression by IHC analysis of tumor specimens.
  • 3. HLA-A02 haplotype.
  • 4. ECOG performance status 0 to 2.
  • 5. 18 years or older.
  • 6. life expectancy ≥3 months.
  • 7. Has following laboratory parameters w/in 28 days:
  • ANC ≥500/mm3
  • ALC >500/mm3
  • PLT ≥25,000/mm3 and may be transfused
  • Hgb >8 g/dL (may have been transfused)
  • Serum creatinine ≤1.5 x ULN
  • Total bilirubin ≤2.0 mg/dL, unless elevated bilirubin due to Gilbert's syndrome
  • ALT and AST less than 5×ULN
  • 8. If female of child-bearing potential, negative serum pregnancy test result w/in 28 of D1 and agree to abstain from heterosexual intercourse or use acceptable method of birth control (hormonal or barrier method) from Screening through 30 days after last dose
  • 9. If male having sexual contact with a female of child-bearing potential, agrees to use a latex condom dor agrees to ensure partner uses an acceptable method of birth control (hormonal or barrier method)from Screening through 30 days after last dose
  • 10. Able to provide written informed consent

Who cannot join

  • Received chemotherapy, biological therapy, or radiation therapy less than one month before D1
  • No prior history of active CNS involvement
  • Grade 2 or higher peripheral neuropathy w/in 28 days
  • Acute promyelocytic leukemia (FAB M3)
  • Other active systemic malignancy treated w/ cytotoxic chemotherapy in previous 12 mos.
  • Monoclonal gammopathy of undetermined significance
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  • For smoldering MM, baseline bone lesions or plasmacytomas
  • For smoldering MM, lytic lesions on skeletal surveys and hypercalcemia (i.e., ≥11 mg/dL)
  • Known HIV or hepatitis virus infection
  • Active infection requiring antibiotics
  • History of prior or active autoimmune disease such as Lupus or rheumatoid arthritis
  • Significant kidney or liver disease, uncontrolled severe cardiovascular or pulmonary disease, other uncontrolled medical condition that would compromise subject's ability to tolerate study treatment
  • Received any investigational treatment w/in 30 days
  • Receiving systemic glucocorticosteroid >10 mg daily. Concurrent use after registration on study should be restricted to equivalent of prednisone 10 mg per day. Prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted. Subject requiring routine use of steroid inhalers are not eligible.
  • Major surgery w/in 4 wks.
  • G-CSF w/in 30 days

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Chicago

    Chicago, Illinois, 60637

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

Other trials in United States

About this study

Official title: Phase I Study of an Oncofetal Antigen ("OFA") Multi-Peptide Immunotherapy ("BBMPI03") in Subjects With Hematologic Cancer

The study is designed to evaluate safety, immunogenicity, and preliminary anti-tumor activity of a multi-peptide immunotherapy (BB-MPI-03) at three peptide+adjuvant dose levels. The peptides stimulate cytotoxic T-cells targeting oncofetal antigen (OFA). Subjects with AML, MM, sMM, or MDS who are off treatment and with stable disease or better, or who are not eligible for or refuse allogeneic HSCT are to be enrolled. The study will be conducted at 2 to 4 study centers in the US.

Read the detailed description

The current study is a Phase I, open-label, multi-center, dose escalation study designed to evaluate safety, immunogencity, and potential anti-tumor activity of BB-MPI-03 at three peptide plus adjuvant dose levels. Subjects with acute myelogenous leukemia (AML), multiple myeloma (MM), smoldering multiple myeloma (sMM), or myelodysplastic syndrome (MDS) who are off treatment and with stable disease or better or who are not eligible for or refuse allogeneic hematopoietic stem cell transplantation (HSCT) are to be enrolled. The study will be conducted at 2 to 4 study centers in the United States (US).

The study employs a sequential group, open-label, 3+3 dose- escalation design to determine the safety and MTD of BB- MPI-03.

Being tested
Sargramostim, BB-MPI-03, Montanide
Keywords
AML, MM, MDS, sMM
Medical subject headings
Leukemia, Myeloid, Acute, Multiple Myeloma, Myelodysplastic Syndromes, Smoldering Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SargramostimDrug

    Also called Leukine

    Drug: Sargramostim (GM-CSF) Other Names: Leukine Sargramostim (250 ug vial) is reconstituted with 0.5 ml of Sterile Water for Injection. Subjects will receive 0.5 ml intradermally (250 µg) near the arm pit or inside of thigh.

  • BB-MPI-03Drug

    Also called Multi-peptide Immunotherapy

    Other Names: Multi-peptide immunotherapy (MPI) is comprised of 3 cytotoxic T-cell epitopes derived from oncofetal antigen. There are 3 dose levels of study vaccine planned to be tested, starting at 0.25 mg each peptide (0.75 mg total peptide dose), then 0.5 mg of each peptide (1.5 mg total) and finally 1 mg each peptide (3 mg total). At the starting dose of 0.75 mg, the BB MPI 03-15 mg vial is used and 100 ul is administered; at the 1.5 mg dose, 200 ul of the BB MPI 03-15 mg vial is used; at the 3 mg dose, 200 ul of the BB MPI 03-30 mg is used.

  • MontanideDrug

    Also called Emulsion

    Drug: Montanide Other Names: mineral oil, USP BB-MPI-03 is emulsified with Montanide and administered intradermally (ID) within 1-2 cm of the 2 sargramostim injection sites 1-3 minutes after sargramostim administration.

    Subjects and the injection sites are to be monitored for 1 hour after sargramostim and BB-MPI-03 emulsion administration.

Study groups in NCT02240537
Study groupRoleWhat they receive
Open Label Treatment ArmExperimentalBB-MPI-03 peptides plus montanide plus sargramostim
Receives: Drug: Sargramostim; Drug: BB-MPI-03; Drug: Montanide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    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.

    Measured: 6 months treatment, 6 months follow-up

Secondary outcomes (2)

  1. 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.

    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).

    Measured: 12 Months

  2. 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.

    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

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2016 (estimated)
  4. Study completionJun 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02240537
Sponsor's protocol ID
BBMPI03-Hem-01
Acronym
BBMPI03
Status last verified
Apr 2016
First submitted
9 Sep 2014
Last updated
19 Apr 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sargramostim, BB-MPI-03 and Montanide in people with Acute Myelogenous Leukemia (AML) and Multiple Myeloma (MM), run by Benovus Bio, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 6 months treatment, 6 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02240537.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.

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