Evidence map›Paper›PMID 39875173›Full record

Trial reportJournal for immunotherapy of cancer2025

Rapamycin-resistant polyclonal Th1/Tc1 cell therapy (RAPA-201) safely induces disease remissions in relapsed, refractory multiple myeloma.

Binod Dhakal, Parameswaran Hari, Saurabh Chhabra, Aniko Szabo, Lawrence G Lum, Deborah D Glass, Jee Hyun Park, Michele Donato, David S Siegel, Tania C Felizardo and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04176380 (Phase II Trial of Autologous Rapamycin-Resistant Th1/Tc1), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT04176380 phase2completednot on this map

Phase II Trial of Autologous Rapamycin-Resistant Th1/Tc1 (RAPA-201) Cell Therapy of Relapsed, Refractory Multiple Myeloma

TypeinterventionalSponsorRapa Therapeutics LLCRan2020 to 2023Enrolled15ConditionsRelapsed, Refractory Multiple MyelomaArmsRAPA-201 Autologous T cells
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

11 authors.

Binod DhakalMedical College of Wisconsin, Milwaukee, Wisconsin, USA bdhakal@mcw.edu.ORCID http://orcid.org/0000-0002-4377-9742
Parameswaran HariMedical College of Wisconsin, Milwaukee, Wisconsin, USA.
Saurabh ChhabraMedical College of Wisconsin, Milwaukee, Wisconsin, USA.
Aniko SzaboMedical College of Wisconsin, Milwaukee, Wisconsin, USA.
Lawrence G LumUniversity of Virginia, Charlottesville, Virginia, USA.ORCID http://orcid.org/0000-0001-7561-6035
Deborah D GlassRapa Therapeutics, Rockville, Maryland, USA.
Jee Hyun ParkRapa Therapeutics, Rockville, Maryland, USA.
Michele DonatoHackensack University Medical Center, Hackensack, New Jersey, USA.
David S SiegelHackensack University Medical Center, Hackensack, New Jersey, USA.
Tania C FelizardoRapa Therapeutics, Rockville, Maryland, USA.
Daniel H FowlerRapa Therapeutics, Rockville, Maryland, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPolyclonal autologous T cells that are epigenetically reprogrammed through mTOR inhibition and IFN-α polarization (RAPA-201) represent a novel approach to the adoptive T cell therapy of cancer. Ex vivo inhibition of mTOR results causes a shift towards T central memory (T

methodsThe clinical trial (NCT04176380) evaluated RAPA-201 therapy in combination with fludarabine-sparing low-dose host conditioning for the treatment of patients with relapsed, refractory multiple myeloma (RRMM).

resultsFrom December 2020 to December 2022, 14 patients with RRMM received a median of three RAPA-201 infusions (median dose, 80×10

conclusionsConsistent with our hypothesis, ex vivo manufacturing using mTOR inhibition and IFN-α polarization consistently yielded a novel RAPA-201 DP that possessed a desirable phenotype relative to cytokine phenotype, memory status, and checkpoint expression. RAPA-201 recipients had preservation of T cell counts and Th1 cytokine secretion yet had increased T cell receptor clonality that associates with antitumor responses in the setting of monoclonal antibody checkpoint therapy. RAPA-201 therapy overcomes previous barriers to effective autologous polyclonal T-cell therapy, as it is feasible to manufacture, exquisitely safe to administer, and mediates remission in patients with RRMM. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT04176380.

Indexed as

Immunotherapy, AdoptiveMultiple MyelomaSirolimusTh1 CellsAdultAgedDrug Resistance, NeoplasmFemaleHumansMaleMiddle AgedRemission InductionSirolimusImmunotherapyMultiple Myeloma

Identifiers

PMID39875173
PMCPMC11781102

What Socratic holds

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Registered trials

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.