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.
RAPA-201 Therapy of Solid Tumors
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Daniel Fowler, M.D. · STUDY_DIRECTOR · Rapa Therapeutics LLC
Who to contact
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What this trial measures
- 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.