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RAPA-201 Therapy of Solid Tumors
NCT05144698 · View on ClinicalTrials.gov ↗
Study Summary
The therapy of solid tumors has been revolutionized by immune therapy, in particular, approaches that activate immune T cells in a polyclonal manner through blockade of checkpoint pathways such as PD-1 by administration of monoclonal antibodies. In this study, the investigators will evaluate the adoptive transfer of RAPA-201 cells, which are checkpoint-deficient polyclonal T cells that represent an analogous yet distinct immune therapy treatment platform for solid tumors. The administration of polyclonal, metabolically-fit RAPA-201 cells is a novel adoptive T cell therapy approach that is suitable for regenerative medicine efforts. RAPA-201 is a novel immunotherapy product consisting of reprogrammed autologous CD4+ and CD8+ T cells of Th1/Tc1 cytokine phenotype. RAPA-201, which have acquired resistance to the mTOR inhibitor temsirolimus, are manufactured ex vivo from peripheral blood mononuclear cells collected from solid tumor patients using a steady-state apheresis. The novel RAPA-201 manufacturing platform, which incorporates both an mTOR inhibitor (temsirolimus) and an anti-cancer Th1/Tc1 polarizing agent (IFN-alpha) generates polyclonal T cells with five key characteristics: 1. Th1/Tc1: polarization to anti-cancer Th1 and Tc1 subsets, with commensurate down-regulation of immune suppressive Th2 and regulatory T (TREG) subsets; 2. T Central Memory: expression of a T central memory (TCM) phenotype, which promotes T cell engraftment and persistence for prolonged anti-tumor effects; 3. Rapamycin-Resistance: acquisition of rapamycin-resistance, which translates into a multi-faceted anti-apoptotic phenotype that improves T cell fitness in the stringent conditions of the tumor microenvironment; 4. T Cell Quiescence: reduced T cell activation, as evidence by reduced expression of the IL-2 receptor CD25, which reduces T cell-mediated cytokine toxicities such as cytokine-release syndrome (CRS) that limit other forms of T cell therapy; and 5. Reduced Checkpoints: multipl
Conditions Studied
Interventions
- BIOLOGICAL RAPA-201 Rapamycin Resistant T Cells
- DRUG Chemotherapy Prior to RAPA-201 Therapy
- DRUG Pembrolizumab (PD-1 Blocking Antibody)
Study Locations (1)
New Jersey
- Hackensack University Medical Center — Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2021-08-01 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05144698
The ClinicalTrials.gov registry entry for NCT05144698 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rapa Therapeutics, which has 29 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 9 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 3 interventions — of which RAPA-201 Rapamycin Resistant T Cells is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05144698 reports 1 study location spanning 1 distinct geographic area — top geographies include New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05144698 about?
NCT05144698 is a clinical study titled "RAPA-201 Therapy of Solid Tumors". The therapy of solid tumors has been revolutionized by immune therapy, in particular, approaches that activate immune T cells in a polyclonal manner through blockade of checkpoint pathways such as PD-1 by administration of monoclonal antibodies. In this study, the investigators will evaluate the ado...
What is the current status of trial NCT05144698?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2021-08-01. Estimated completion is 2026-12-31.
What conditions does trial NCT05144698 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Solid Tumor, Malignant Melanoma, Esophageal Squamous Cell Carcinoma, Squamous Cell Carcinoma of Oral Cavity. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05144698?
The interventions under investigation include: RAPA-201 Rapamycin Resistant T Cells (BIOLOGICAL), Chemotherapy Prior to RAPA-201 Therapy (DRUG), Pembrolizumab (PD-1 Blocking Antibody) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05144698?
This trial is sponsored by Rapa Therapeutics, which has 29 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05144698 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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