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CAR T-cell Therapy
RAPA-201 Immunotherapy for Solid Cancers
Phase 1 & 2
Recruiting
Research Sponsored by Rapa Therapeutics LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Exposure to an anti-PD-(L)1 monoclonal antibody therapeutic in the most recent line of prior therapy
Must have a potential source of autologous T cells potentially sufficient to manufacture RAPA-201 cells, as defined by a circulating absolute lymphocyte count (ALC) of ≥ 300 cells/μL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one (1) year after the last dose of rapa-201 cells.
Awards & highlights
Study Summary
This trial is a study of a new cancer treatment called RAPA-201. RAPA-201 is a second-generation immunotherapy product consisting of reprogrammed autologous CD4+ and CD8+ T cells of Th1/Tc1 cytokine phenotype. The study will evaluate the adoptive transfer of RAPA-201 cells in patients with advanced metastatic, recurrent, and unresectable solid tumors that have recurred or relapsed after prior immune therapy.
Who is the study for?
This trial is for adults with advanced solid tumors that have not responded to prior treatments including anti-PD-(L)1 therapy. Participants must be in relatively good health, with a performance status of ≤ 2 and adequate organ function. They should not have central nervous system metastasis or other active cancers, and must agree to use contraception if applicable.Check my eligibility
What is being tested?
The study tests RAPA-201 T cell therapy combined with standard chemotherapy (carboplatin + paclitaxel). It's designed for patients whose tumors didn't respond to checkpoint inhibitor therapies. The goal is to see if this new treatment can shrink the tumors in patients who've already tried other treatments.See study design
What are the potential side effects?
Potential side effects include typical chemotherapy-related issues like fatigue, nausea, low blood counts leading to increased infection risk, as well as possible immune-related reactions from the novel T cell therapy which could affect different organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was treated with an anti-PD-(L)1 drug in my last treatment.
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My blood has enough lymphocytes to make a specific cancer treatment.
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My heart pumps well, with an ejection fraction of 40% or higher.
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I do not have a history of unusual bleeding.
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My kidneys are functioning well.
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My cancer has returned or spread and cannot be removed by surgery after at least one treatment.
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My solid tumor is treatable with carboplatin and paclitaxel before T cell therapy.
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My cancer did not respond or came back within a year after treatment with an anti-PD-(L)1 drug.
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I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one (1) year after the last dose of rapa-201 cells.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one (1) year after the last dose of rapa-201 cells.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety of RAPA-201 Cell Therapy
Secondary outcome measures
Overall Response Rate
Progression Free Survival (PFS) and Overall Survival (OS)
Quality of Life (QOL)
Other outcome measures
T Cell Immune Reconstitution
Trial Design
1Treatment groups
Experimental Treatment
Group I: Administration of RAPA-201 cellsExperimental Treatment2 Interventions
RAPA-201 cells will be administered at a target flat dose of 400 x 10^6 cells per infusion.
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Who is running the clinical trial?
Rapa Therapeutics LLCLead Sponsor
4 Previous Clinical Trials
69 Total Patients Enrolled
Daniel Fowler, M.D.Study DirectorRapa Therapeutics LLC
3 Previous Clinical Trials
69 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your AST and ALT levels should be less than 3 times the upper limit of normal.Your absolute neutrophil count is at least 1500 cells per microliter.Your bilirubin level should be less than 1.5 mg/dL, unless you have Gilbert's disease.Your platelet count should be at least 100,000 cells per microliter.I have HIV, hepatitis B, or C but it's under control with treatment.I have not had a heart attack in the last 6 months.I have severe heart failure.I was treated with an anti-PD-(L)1 drug in my last treatment.My blood has enough lymphocytes to make a specific cancer treatment.It's been over two weeks since my last cancer treatment or surgery.My heart pumps well, with an ejection fraction of 40% or higher.I do not have a history of unusual bleeding.My kidneys are functioning well.My cancer has returned or spread and cannot be removed by surgery after at least one treatment.I do not have any active cancer except for non-melanoma skin cancer.You are not expected to live more than 4 months.I am of childbearing age and not willing to use birth control.My solid tumor is treatable with carboplatin and paclitaxel before T cell therapy.My brain metastasis has been treated.I have either undergone or refused recommended treatments for my condition.My cancer did not respond or came back within a year after treatment with an anti-PD-(L)1 drug.My high blood pressure is not under control.Your hemoglobin level is at least 8 grams per microliter.I can take care of myself and am up and about more than half of my waking hours.I have a solid tumor with genetic changes and have either been treated for it or officially refused treatment.You have a disease that can be measured and monitored using specific criteria.I have not had a stroke in the last 6 months.I have recovered from major side effects of previous treatments.I have uncontrolled chest pain due to heart disease.Your lung function test shows that your ability to transfer oxygen into your blood is at least 50%.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Administration of RAPA-201 cells
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please discuss the potential hazards related to RAPA-201 Rapamycin Resistant T Cells?
"Despite being in the second phase of trials, RAPA-201 Rapamycin Resistant T Cells have received a safety score of 2 due to available evidence. Yet, there is yet no proof that it works as intended."
Answered by AI
To what extent is enrollment being sought for this clinical experiment?
"Affirmative. Clinicaltrials.gov indicates that, since its initial posting on August 1st 2021 and last update on December 23rd 2021 , this study is actively seeking out 22 participants at one site."
Answered by AI
What health-related issues has RAPA-201 Rapamycin Resistant T Cells been utilized to treat?
"Rejection of liver transplants can be combatted with RAPA-201 Rapamycin Resistant T Cells. This medication is also efficacious in treating diseases, kidney issues and renal angiomyolipomas."
Answered by AI
Is enrollment in this trial still an option for potential participants?
"Indeed. The records hosted on clinicaltrials.gov demonstrate that this research is presently recruiting volunteers. This endeavour was created in August 2021 and recently revised during December of the same year. 22 subjects need to be enrolled from 1 particular location."
Answered by AI
Could you please provide a list of studies that have previously explored the efficacy of RAPA-201 Rapamycin Resistant T Cells?
"Presently, 125 trials are being conducted to evaluate the efficacy of RAPA-201 Rapamycin Resistant T Cells. 13 out of these studies have reached Phase 3 and many facilities in Cincinnati, Ohio are contributing their findings. Altogether, 1074 sites around the globe are running experiments for this therapy."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
What portion of applicants met pre-screening criteria?
Met criteria
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