NCT04444622 (STIMVAX) is a Phase 2 clinical trial of AlloStim in Metastatic Colorectal Cancer, sponsored by Mirror Biologics, Inc..

Who is sponsoring NCT04444622?

NCT04444622 is sponsored by Mirror Biologics, Inc..

What drugs are being tested in NCT04444622?

Interventions in NCT04444622: AlloStim.

What condition does NCT04444622 study?

NCT04444622 studies Metastatic Colorectal Cancer.

Is NCT04444622 still recruiting?

NCT04444622 is currently completed. Last updated 20 October 2025.

Last reviewed 2025-10-20 · How we verify

NCT04444622: STIMVAX

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Immunotherapy for Third Line Metastatic Colorectal Cancer

Completed Phase 2 Last updated 20 October 2025

What this trial tests

Phase 2 trial testing AlloStim in Metastatic Colorectal Cancer in 29 participants. Completed in 31 March 2025.

Timeline

12 July 2021

Primary endpoint
31 March 2025

31 March 2025

Quick facts

Lead sponsor	Mirror Biologics, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	12 July 2021
Primary completion	31 March 2025
Estimated completion	31 March 2025
Sites	4 locations across United States

Drugs / interventions tested

AlloStim — full drug profile →

Conditions studied

Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →

Sponsor

Mirror Biologics, Inc. — full company profile →

Who can join

18 and older, any sex, with Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Intratumor heterogeneity: the hidden barrier to immunotherapy against MSI tumors from the perspective of IFN-γ signaling and tumor-infiltrating lymphocytes.
Wu W, Liu Y, Zeng S, Han Y, et al · · 2021 · cited 62× · PMID 34620200 · DOI 10.1186/s13045-021-01166-3
STING Protein-Based In Situ Vaccine Synergizes CD4+ T, CD8+ T, and NK Cells for Tumor Eradication.
He Y, Hong C, Huang S, Kaskow JA, et al · · 2023 · cited 13× · PMID 37015729 · DOI 10.1002/adhm.202300688
Breaking barriers: Smart vaccine platforms for cancer immunomodulation.
Gomari MM, Ghantabpour T, Pourgholam N, Rostami N, et al · · 2025 · cited 5× · PMID 39901621 · DOI 10.1002/cac2.70002
Clinical Applications of Combined Immunotherapy Approaches in Gastrointestinal Cancer: A Case-Based Review.
Eralp Y, Ates U. · · 2023 · cited 2× · PMID 37896948 · DOI 10.3390/vaccines11101545
Immunotherapy for precision medicine in colorectal cancer.
Cao M, Xu M, Bairmani Z, Bashir B, et al · · 2025 · PMID 41040627 · DOI 10.1080/23808993.2025.2560303
AlloStim® Immunotherapy Demonstrates Strong Survival Signal in Third-Line Microsatellite Stable Metastatic Colorectal Cancer: Results of a Phase 2B Clinical Trial
Hirschfeld A, Al Hallak MN, Cusnir M, Yang X, et al · · 2025 · DOI 10.20944/preprints202508.1292.v1
Objective Response after Immune Checkpoint Inhibitors in a Chemotherapy-Refractory pMMR/MSS Metastatic Rectal Cancer Patient Primed with Experimental AlloStim® Immunotherapy.
Hirschfeld A, Gurell D, Har-Noy M. · · 2024 · DOI 10.21203/rs.3.rs-4166800/v1
Harnessing allogeneic CD4+ T cells to reinvigorate host endogenous antitumor immunity.
Mochizuki K. · · 2023 · PMID 37880140 · DOI 10.5387/fms.23-00001

Verify or expand the search:

Other trials of AlloStim

Trials testing the same drug.

NCT04441047 — Universal Anti-Viral Vaccine for Healthy Elderly Adults · Phase 1, PHASE2 · completed

Other recruiting trials for Metastatic Colorectal Cancer

Currently open trials in the same condition.

NCT07416552 — A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC) · Phase 1 · recruiting
NCT07314294 — Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients · Phase 2 · recruiting
NCT06856837 — - IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Misma · Phase 2 · recruiting
NCT06959550 — Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorect · Phase 2 · recruiting
NCT06808685 — Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie · recruiting

Other Mirror Biologics, Inc. trials

Trials by the same sponsor.

NCT05033522 — Immunotherapy for Advanced Liver Cancer · Phase 2, PHASE3 · suspended
NCT04441047 — Universal Anti-Viral Vaccine for Healthy Elderly Adults · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04444622 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Mirror Biologics, Inc.
Last refreshed: 20 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04444622.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing