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Advanced or Refractory Leukemia, Lymphoma, Multiple MyelomaPhase 1/2NCT00861965

Bioengineered Allogeneic Immune Cells (AlloStim) Not Requiring HLA Donor Match for Blood Cancers

A Phase 1/2 study testing AlloStim-8 in people with Advanced or Refractory Leukemia, Lymphoma, Multiple Myeloma, run by Mirror Biologics, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase I/II clinical investigation is designed to determine the safety and anti-tumor effects of intravenous administration of the experimental immunotherapy drug, called AlloStim. The active ingredient of AlloStim is living, human immune cells that have been differentiated and expanded outside the body. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AlloStim-8
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
Jan 2010to Apr 2011
Phase
Phase 1/2
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

  • Histologically confirmed hematological malignancy of 1 of the following types:
  • Acute Myeloid Leukemia (AML) meeting the following criteria:
  • Relapsed or primary refractory disease with ≤ 10% blasts in the peripheral blood and ≤ 20% blasts in the bone marrow.
  • Acute Lymphoblastic Leukemia (ALL) meeting the following criteria:
  • Relapsed or primarily refractory disease with ≤ 10% blasts in the peripheral blood and ≤ 20% blasts in the bone marrow
  • Chronic Myeloid Leukemia (CML)* with an inadequate response to imatinib meeting 1 of the following criteria:
Show all 39Show fewer
  • Second or subsequent chronic phase
  • Accelerated phase [*Patients with CML in blast crisis (> 30% promyelocytes and myeloblasts in the bone marrow) are not eligible]
  • Non-Hodgkin's Lymphoma (NHL) including Mantle Cell Lymphoma (MCL) meeting 1 of the following criteria:
  • Primary refractory disease or in refractory relapse
  • Relapsed disease after autologous stem cell transplantation
  • Chemosensitive relapsed disease without CR to standard salvage therapy AND no option for autologous stem cell transplantation due to blood or marrow involvement or failure to harvest sufficient autologous stem cells.
  • Chronic Lymphocytic Leukemia (CLL) meeting both of the following criteria:
  • Stage III or IV disease
  • Refractory to fludarabine, Rituxan® and Campath® or refuses
  • Multiple Myeloma (MM) meeting 1 of the following criteria:
  • Primary refractory disease or in refractory relapse
  • Relapsed disease after autologous stem cell transplantation
  • Hodgkin's Disease
  • Relapsed after prior autologous transplant or after 2 or more combination chemotherapy regimens and ineligible for autologous stem cell transplant.
  • EBV driven lymphoproliferative disorders in immunocompetent patients progressing despite standard therapies, including:
  • T-cell Non-Hodgkin's Lymphoma
  • Burkitt's Lymphoma
  • EBV+ Hodgkin's Disease
  • Ability to comprehend the investigational nature of the study and provide informed consent.
  • Measurable or evaluable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of <2.
  • Age 18 years or older
  • Expected survival 6 months or longer
  • No radiation or chemotherapy in previous 2 weeks
  • No immunotherapy in the previous 4 weeks
  • Absence of active infection within 2 weeks
  • Adequate hepatic function, with total bilirubin level less than 1.2 times the upper limit of normal (ULN) and aspartate and alanine aminotransferase levels less than 2.5 times the ULN prior to infusion
  • Adequate bone marrow function defined as a white blood cell count of at least 2 x 109/L (2000/µL), absolute neutrophil count of at least 1 x 109/L (1000/µL), hemoglobin level of at least 80 g/L (8.0 g/dL), and a platelet count of at least 50 x 109/L (50,000/µL) priot to infusion. Patients who are transfusion- or growth factor-dependent are allowed, provided these values could be achieved with transfusion.
  • Adequate cardiovascular function defined as no ischemia, no new conduction system abnormalities, no class 3 or 4 New York Heart Association congestive heart failure, and no myocardial infarction in the previous 6 months. A ≥45% left ventricular ejection fraction (LVEF) required in the previous 6 months.
  • Adequate kidney function defined as serum creatinine level 1.5 mg/dL or less, or an estimated creatinine clearance level of at least 60 mL/min prior to infusion.
  • Adequate lung function defined as pulse oxymetry greater than or equal to 92% on room air prior to infusion, DLco≥50%, FEV1 and FVC ≥50% within 2 weeks
  • No known allergy to murine products or HAMA testing results within normal limits
  • No known allergy to bovine products

Who cannot join

  • No pregnancy or breast feeding
  • No known human immunodeficiency virus (HIV+)
  • No seropositivity or active viral hepatitis (HBV+, HCV+)
  • No prior allogeneic transplant (cell or organ)
  • No serious concomitant medical or psychiatric conditions that could interfere with treatment.
  • No EBV-induced lymphomas associated with immunosuppression, including patients with iatrogenic immunodeficiencies (such as organ transplant) or HIV-related immunodefiency.
  • No chronic myelogenous leukemia in blast crisis.
  • No myelodysplastic syndromes with refractory anemia

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Immunovative Clinical Research, Inc

    Carlsbad, California, 92010

Other trials in United States

About this study

Official title: A Phase I/II Study of Polyclonally Activated, Intentionally Mis-Matched, Allogeneic Th1 Memory Cells (AlloStimTM) in Patients With Relapsed or Refractory Hematological Malignancy Without Prior Conditioning

This phase I/II clinical investigation is designed to determine the safety and anti-tumor effects of intravenous administration of the experimental immunotherapy drug, called AlloStim. The active ingredient of AlloStim is living, human immune cells that have been differentiated and expanded outside the body. Because AlloStim does not require HLA match, it is being evaluated as an alternative to allogeneic bone marrow/stem cell transplantation.

Read the detailed description

AlloStim is being tested to determine if it might elicit the same anti-tumor mechanism that occurs in allogeneic bone marrow/stem cell transplant (BMT) procedures, without the toxicity associated with graft vs. host disease (GVHD). In allogeneic BMT settings, patients are first conditioned to weaken the immune system in order to enable the engraftment of allogeneic donor cells. Patients require a matched-tissue donor in this setting in order to enable engraftment and also to minimize GVHD toxicity. While allogeneic BMT is a potentially curatve therapy, the treatment-related mortality, mostly related to GVHD toxicity, is high. This toxicity limits the clinical utility of this procedure. AlloStim is being tested to determine if it might be a less toxic alternative to allogeneic BMT.

In this protocol, patients are not conditioned with chemotherapy prior to treatment. Therefore, the allogeneic cells in AlloStim are expected to be rejected by the patient's immune system within 24-48 hours of infusion.

Being tested
AlloStim-8
Keywords
Leukemia, Lymphoma, Multiple Myeloma
Medical subject headings
Leukemia, Lymphoma, Multiple Myeloma

What participants receive

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

  • AlloStim-8Biological

    intravenous infusion of mis-matched AlloStim-8

  • AlloStim-8Biological

    intravenous infusion of AlloStim-8 on day 7

  • AlloStim-8Biological

    intravenous infusion of AlloStim-8 on day 14

  • AlloStim-8Biological

    intravenous infusion of AlloStim-8 on day 21

Study groups in NCT00861965
Study groupRoleWhat they receive
TreatmentExperimentalAlloStim-8
Receives: Biological: AlloStim-8

What is being measured

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

  1. To evaluate the safety of administration of an intravenous AlloStim-9 infusion and to define any drug-related toxicity and reversibility of such toxicity

    Measured: 7 days

  2. evaluate the safety of administration of up to three consecutive daily intravenous AlloStim-8 booster infusions in patients that previously received a infusion of AlloStim-9 and to define any drug-related toxicity and reversibility of such toxicity

    Measured: 90 days

Secondary outcomes (1)

  1. evaluate the anti-tumor effect of AlloStim infusions by evaluating the objective response rates

    Measured: 90 days

Timeline

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

  1. First posted16 Mar 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionMar 2011
  4. Study completionApr 2011

Why it stopped: withdrawn due to poor recruitment

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00861965
Sponsor's protocol ID
ITL-001-HM
Status last verified
Apr 2015
First submitted
12 Mar 2009
Last updated
22 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Har-Noy M, Zeira M, Weiss L, Fingerut E, Or R, Slavin S. Allogeneic CD3/CD28 cross-linked Th1 memory cells provide potent adjuvant effects for active immunotherapy of leukemia/lymphoma. Leuk Res. 2009 Apr;33(4):525-38. doi: 10.1016/j.leukres.2008.08.017. Epub 2008 Oct 1.

    PubMed 18834631

  • Har-Noy M, Zeira M, Weiss L, Slavin S. Completely mismatched allogeneic CD3/CD28 cross-linked Th1 memory cells elicit anti-leukemia effects in unconditioned hosts without GVHD toxicity. Leuk Res. 2008 Dec;32(12):1903-13. doi: 10.1016/j.leukres.2008.05.007. Epub 2008 Jun 18.

    PubMed 18565579

  • Har-Noy M, Slavin S. The anti-tumor effect of allogeneic bone marrow/stem cell transplant without graft vs. host disease toxicity and without a matched donor requirement? Med Hypotheses. 2008;70(6):1186-92. doi: 10.1016/j.mehy.2007.10.008. Epub 2007 Dec 3.

    PubMed 18054441

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AlloStim-8 in people with Advanced or Refractory Leukemia, Lymphoma, Multiple Myeloma, run by Mirror Biologics, Inc. at 1 site 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 39 inclusion and 8 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: stopped early, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study was stopped early (reason given: withdrawn due to poor recruitment). 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?

To evaluate the safety of administration of an intravenous AlloStim-9 infusion and to define any drug-related toxicity and reversibility of such toxicity (time frame: 7 days). The study lists 2 primary outcomes in all. 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 NCT00861965, which also lists 3 linked publications.

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 22 Jan 2020.

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