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AzTrials

Metastatic Colorectal CancerPhase 2STIMVAXNCT04444622

Immunotherapy for Third Line Metastatic Colorectal Cancer

A Phase 2 study testing AlloStim in people with Metastatic Colorectal Cancer, run by Mirror Biologics, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase IIB multi-site, open label study of a next generation immunotherapy for third-line MSI-S metastatic colorectal cancer using an "off-the-shelf", non-genetically manipulated living immune cell product (AlloStim) derived from the blood of healthy donors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
AlloStim
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
4 sitesUnited States
Study dates
12 Jul 2021to 31 Mar 2025
Phase
Phase 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

  • Adult males and female subjects aged 18-80 years at screening visit
  • Pathologically confirmed diagnosis of colorectal adenocarcinoma
  • Presenting with metastatic disease:
  • Previous treatment failure of two previous lines of active systemic chemotherapy:
  • Previous chemotherapy must have included an oxaliplatin-containing (e.g. FOLFOX) and an irinotecan-containing (e.g. FOLFIRI) regimen
  • With or without bevacizumab
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  • Administered in adjuvant setting or for treatment of metastatic disease
  • If KRAS wild type, must have at least one prior anti-EGFR therapy
  • Treatment failure can be due to disease progression or toxicity
  • Disease progression on second line therapy must be documented radiologically and must have occurred during or within 30 days following the last administration of treatment for metastatic disease
  • ECOG performance score: 0-1
  • Adequate hematological function:
  • Absolute granulocyte count ≥ 1,200/mm3
  • Platelet count ≥ 100,000/mm3
  • PT/INR ≤ 1.5 or correctable to <1.5 at time of interventional procedures
  • Hemoglobin ≥ 9 g/dL (may be corrected by transfusion)
  • Adequate Organ Function:
  • Creatinine ≤ 1.5 mg/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN *
  • Aspartate aminotransferase (AST) or (SGOT) ≤ 2.5 times ULN *
  • Alanine aminotransferase (ALT) or (SGPT) ≤ 2.5 times ULN * *or ≤5x ULN if liver involvement
  • EKG without clinically relevant abnormalities
  • Female subjects: Not pregnant or lactating
  • Patients with child bearing potential must agree to use adequate contraception
  • Study specific informed consent in the native language of the subject.

Who cannot join

  • high frequency microsatellite instability (MSI-H)
  • Bowel obstruction or high risk for obstruction if tumors become inflamed
  • Moderate or severe ascites requiring medical intervention
  • Clinical evidence or radiological evidence of brain metastasis or leptomeningeal involvement
  • Peritoneal carcinomatosis
  • Symptomatic asthma or COPD
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  • Pulmonary lymphangitis or symptomatic pleural effusion (grade ≥ 2) that results in pulmonary dysfunction requiring active treatment; or, oxygen saturation <92% on room air
  • Bevacizumab (Avastin®) treatment within 6 weeks of baseline scheduled biopsy procedure
  • Any of the following mood disorders: active major depressive episode, history of suicidal attempt or ideation
  • Prior allogeneic bone marrow/stem cell or solid organ transplant
  • Chronic use (> 2 weeks) of greater than physiologic doses of a corticosteroid agent (dose equivalent to > 5 mg/day of prednisone) within 30 days of the first day of study drug treatment
  • Topical corticosteroids are permitted
  • Prior diagnosis of an active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, autoimmune thyroid disease, uveitis).
  • Well controlled Type I diabetes allowed
  • Prior experimental therapy
  • History of blood transfusion reactions
  • Progressive viral or bacterial infection
  • All infections must be resolved and the subject must remain afebrile for seven days without antibiotics prior to being placed on study
  • Cardiac disease of symptomatic nature
  • History of HIV positivity or AIDS
  • Concurrent medication known to interfere with platelet function or coagulation (e.g., aspirin, ibuprofen, clopidogrel, or warfarin) unless such medications can be discontinued for an appropriate time period based on the drug half-life and known activity (e.g., aspirin for 7 days) prior to biopsy procedures
  • History of severe hypersensitivity to monoclonal antibody drugs
  • Psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude study participation.
  • Subjects that lack ability to provide consent for themselves.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Summit Health

    Florham Park, New Jersey, 07932

  • Mt. Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Hirschfield Oncology Center

    The Bronx, New York, 10469

Other trials in United States

About this study

Official title: Phase IIB Open-Label Study to Assess the Safety and Efficacy of STIMVAX® as Third-line Therapy for Metastatic Colorectal Cancer

This is a Phase IIB multi-site, open label study of a next generation immunotherapy for third-line MSI-S metastatic colorectal cancer using an "off-the-shelf", non-genetically manipulated living immune cell product (AlloStim) derived from the blood of healthy donors.

Read the detailed description

This is a Phase IIB open label immunotherapy protocol called "StimVax". The protocol design is based upon information obtained from a previous Phase IIA dose level and dose frequency ranging study. The population targeted is MSI-S metastatic colorectal cancer previously treated with two lines of chemotherapy regimens, one containing oxaliplatin and the other containing irinotecan. This population is not considered to be responsive to immunotherapy.

The study drug is called "AlloStim". AlloStim is an "off-the-shelf", non-genetically-manipulated, living immune cell immunotherapy. AlloStim is derived from precursors purified from the blood of healthy donors and grown and differentiated in specialized bioreactors in the laboratory. Because the donors are intentionally mis-matched to the host, AlloStim is completely eliminated by the host in a non-toxic rejection response within 24h of administration.

Unlike autologous immune cell therapies, like CAR-T cells or TIL cells, AlloStim is allogeneic and is not intended to directly kill tumors. Rather, the novel AlloStim mechanism is designed to modify and train the host immune system to kill tumors and prevent tumor growth and spread. Uniquely, the AlloStim mechanism is also designed to increase Th1/Th2 balance, activate innate effector cells (such as NK and NKT), counter-regulate the immune suppressive and immune evasion mechanisms that tumors use to evade immune elimination both systemically and in the tumor microenvironment.

The AlloStim mechanism creates self-amplifying waves of temporal and spatial immune effects that can lead to an initial non-specific cellular innate NK cell immune response followed by a tumor-specific killer T-cell immune response specific for the host tumor through a combination of immune processes called "allo-priming" and "in-situ vaccination".

Being tested
AlloStim
Keywords
immunotherapy, cancer vaccine, colorectal cancer, AlloStim, MSI-S
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • AlloStimBiological

    Also called StimVax

    Living bioengineered, non-genetically manipulated, activated Th1-like immune cells differentiated and expanded from precursor cells purified from blood of healthy unrelated donors

Study groups in NCT04444622
Study groupRoleWhat they receive
AlloStimExperimentalAlloStim is administered in three cycles: Cycle 1 Day 0: 0.5ml ID AlloStim® Day 7: 0.5ml ID AlloStim® Day 14: 0.5ml ID AlloStim® Day 21: 0.5ml ID AlloStim® Day 28: 0.5ml ID AlloStim® Cycle 2 Day 42: 0.5ml ID AlloStim® Day 49: 0.5ml ID AlloStim® Day 56: 0.5ml ID AlloStim® Day 63: 0.5ml ID AlloStim® Day 70: 0.5ml ID AlloStim® + 3ml IV AlloStim® Cycle 3 Day 84: 0.5ml ID AlloStim® Day 91: 0.5ml ID AlloStim® Day 98: 0.5ml ID AlloStim® Day 105: 0.5ml ID AlloStim® Day 112: 0.5ml ID AlloStim® + 3ml IV AlloStim®
Receives: Biological: AlloStim

What is being measured

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

  1. Overall Survival

    measurement of the survival on experimental treatment

    Measured: date of death from any cause, whichever came first, assessed up to 12 months from accrual

  2. Incidents of Adverse Events (AE)

    to evaluate safety and tolerability

    Measured: day 0 to 1 year

Timeline

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

  1. First posted23 Jun 2020
  2. Study start12 Jul 2021
  3. Primary completion31 Mar 2025
  4. Study completion31 Mar 2025

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04444622
Sponsor's protocol ID
ITL-032-MCRC3-STIM
Acronym
STIMVAX
Status last verified
Oct 2025
First submitted
19 Jun 2020
Last updated
20 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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 2 study testing AlloStim in people with Metastatic Colorectal Cancer, run by Mirror Biologics, Inc. at 4 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 26 inclusion and 24 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: finished, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall Survival (time frame: date of death from any cause, whichever came first, assessed up to 12 months from accrual). 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 NCT04444622, which also lists 1 linked publication.

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 20 Oct 2025.

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