RAPA-201 Therapy for Advanced Solid Tumors

This study is testing a new type of immunotherapy called RAPA-201 for people with advanced solid tumors, including lung cancer and head and neck cancer. RAPA-201 uses your own immune cells (T cells) that have been specially reprogrammed to fight cancer. Before receiving RAPA-201, you would have chemotherapy with Carboplatin and Paclitaxel. After RAPA-201, you would receive Pembrolizumab, another immunotherapy drug. Researchers want to see how safe RAPA-201 is when given with this chemotherapy and how well it works. This study is for adults aged 18 and older whose cancer has returned or spread after previous treatments. The study plans to enroll 37 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 37 participants, but the phase and current status are not specified.
What's involved
You would receive chemotherapy with Carboplatin and Paclitaxel, followed by RAPA-201 therapy, and then Pembrolizumab. The primary endpoint is measured at an average of 18 months after treatment starts.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for about 18 months after starting treatment to monitor for side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05144698

RAPA-201 Therapy of Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Rapa Therapeutics LLC
~37 participants
Updated 2025-05-14 on ClinicalTrials.gov
What's tested:RAPA-201 Rapamycin Resistant T CellsChemotherapy Prior to RAPA-201 TherapyPembrolizumab (PD-1 Blocking Antibody)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the rate of Treatment Emergent Adverse Events of RAPA-201 using host conditioning of Carboplatin plus Paclitaxel
Measured over Completion of RAPA-201 Therapy plus combination anti-PD1 maintenance therapy; occurs on average at 18-months after treatment initiation
Solid Tumor
Small Cell and Non-small Cell Lung Cancer
Head and Neck Cancer
Squamous Cell Carcinoma of Oral Cavity
Squamous Cell Carcinoma of Larynx
Squamous Cell Carcinoma of Nasopharynx
Squamous Cell Carcinoma of Other Specified Sites of Skin
Malignant Melanoma
Esophageal Squamous Cell Carcinoma
1 sites across 1 states
New Jersey1
  • Daniel Fowler, M.D. · STUDY_DIRECTOR · Rapa Therapeutics LLC

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  • Determine the rate of Treatment Emergent Adverse Events of RAPA-201 using host conditioning of Carboplatin plus PaclitaxelCompletion of RAPA-201 Therapy plus combination anti-PD1 maintenance therapy; occurs on average at 18-months after treatment initiation

    To determine the safety of RAPA-201 cell therapy when used in combination with a carboplatin plus paclitaxel (CP) standard-of-care chemotherapy regimen and in combination with anti-PD1 maintenance therapy. Specifically, the treatment will be determined to be safe if the following parameters are met: (Metric #1) using the metric of "grade 4/grade 5 toxicity toxicity attributable to the RAPA-201 cell therapy": for positive determination of safety, this metric must occur in 1 or fewer patients out of the initial 10 patients.