Immunotherapy for Third Line Metastatic Colorectal Cancer

NCT04444622 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: ITL-032-MCRC3-STIM
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Metastatic Colorectal Cancer

Keywords

immunotherapy; cancer vaccine; colorectal cancer; AlloStim; MSI-S

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  measurement of the survival on experimental treatment

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

• Incidents of Adverse Events (AE)

  to evaluate safety and tolerability

  day 0 to 1 year

Study Arms (1)

AlloStim

EXPERIMENTAL

AlloStim 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®

Biological: AlloStim

Interventions

AlloStim BIOLOGICAL

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

Also known as: StimVax

AlloStim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mirror Biologics, Inc.: lead

Study Sites (4)

Mt. Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Summit Health

Florham Park, New Jersey, 07932, United States

Location

Hirschfield Oncology Center

The Bronx, New York, 10469, United States

Location

Related Publications (1)

• 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.

  PMID: 18054441 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 23, 2020
• Study Start: July 12, 2021
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (4)