Evidence mapPaperPMID 42335577Full record

ArticleTranslational oncology2026

Clinical translation of an immunomodulatory cell therapy that is designed to convert "cold" tumors to "hot": A phase 2B trial in 3L MSS/pMMR metastatic colorectal cancer.

A Hirschfeld, M N Al Hallak, M Cusnir, X Yang, P Piyapan, W Lausoontornsiri, R Shane, M Har-Noy

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Article in Translational oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

A HirschfeldHirschfeld Oncology, Brooklyn NY, USA.
M N Al HallakKarmanos Cancer Institute, Wayne State University, Detroit MI, USA.
M CusnirMount Sinai Medical Center, Miami, FL, USA.
X YangMirror Biologics, Inc., Tampa, FL, USA.
P PiyapanSamitivej Sukhumvit Hospital, Bangkok, Thailand.
W LausoontornsiriSamitivej Sukhumvit Hospital, Bangkok, Thailand.
R ShaneMirror Biologics, Inc., Tampa, FL, USA.
M Har-NoyImmunovative Therapies, Ltd., Jerusalem, Israel. Electronic address: harnoy@immunovative.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA translational immunotherapy framework was designed to initiate sequential spatial and temporal immunomodulatory cascades using living, allogeneic, activated memory Th1 cells (AlloStim®), hypothesized to promote an immunomodulatory cascade in immunologically "cold" tumors. Microsatellite stable/proficient mismatch repair (MSS/pMMR) metastatic colorectal cancer (CRC) represents an immunotherapy-refractory "cold" tumor archetype with historically low response rates.

methodsTo evaluate this framework, a Phase 2B, single-arm, multi-center proof-of-concept trial was conducted in third-line MSS/pMMR metastatic CRC patients, utilizing overall survival (OS) as the primary endpoint. AlloStim® was administered via a sequential schedule of weekly intradermal priming and subsequent intravenous infusions over three 5-week cycles, followed by optional monthly intravenous boosters.

resultsTwenty-nine patients were enrolled (18 death events, 11 censored cases [37.9%]). The median OS was 16.4 months (492 days; 95% CI: 8.6-20.8 months). To account for non-proportional hazards, Restricted Mean Survival Time (RMST) evaluated at a 32-month temporal horizon demonstrated an average cohort life expectancy of 16.1 months (482 days; 95% CI: 12.3-19.8 months). Concurrently, 89% of evaluable patients met RECIST 1.1 criteria for progressive disease at Day 119, highlighting a profound survival-radiological discordance. The protocol was well tolerated; only 4% of total adverse events were ≥ Grade 3.

conclusionThis study provides indirect clinical observations supporting the hypothesis that an active immunomodulatory framework may elicit an encouraging survival signal and extended life expectancy in refractory metastatic MSS/pMMR CRC, despite conventional radiological progression. These findings justify evaluation in a prospective, randomized controlled trial powered to validate this translational strategy.

Indexed as

Cold/hot tumorImmunological cell deathImmunotherapyIn-situ vaccinationMetastatic colorectal cancerMicrosatellite stableNeoantigen cancer vaccineProficient mis-match repair

Identifiers

PMID42335577
PMCPMC13320496

What Socratic holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.