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NCT05144698 · ClinicalTrials.gov registry record · Phase 1
RAPA-201 Therapy of Solid Tumors
A Phase 1 study of Head and Neck Cancer and Solid Tumor, sponsored by Rapa Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT05144698 is a Phase 1 study of Head and Neck Cancer and Solid Tumor that is actively recruiting participants, run by Rapa Therapeutics. The registered enrollment target is 37 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05144698, a Phase 1 study of Head and Neck Cancer and Solid Tumor, is actively recruiting participants, sponsored by Rapa Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (86% lower). The listed sponsor is Rapa Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.
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.
NCT05144698 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.
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.
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).
Who is sponsoring clinical trial NCT05144698?
This trial is sponsored by Rapa Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
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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