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New treatment option for Solid Tumor
Official title RAPA-201 Therapy of Solid Tumors
ClinicalTrials.gov ID: NCT05144698
What this study is testing
What is RAPA-201 Rapamycin Resistant T Cells?
RAPA-201 Rapamycin Resistant T Cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor.
Also referred to as RAPA-201 cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female patients ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Advanced metastatic, recurrent, and unresectable solid tumor that has relapsed after ≥ one prior line of therapy.
- Subject must have received prior therapy with disease-specific regimens that have been established to convey a clinical benefit. Alternatively...
- Subject with solid tumors with genetic alterations and mutations (including but not limited to BRAF, BRCA, EGFR mutations, and ALK translocations)...
You likely can't join if
- Other active malignancy (except non-melanoma skin cancer).
- Life expectancy \< 4 months.
- Seropositivity for HIV, hepatitis B, or hepatitis C, unless such conditions are in stable condition using adequate treatment.
- Uncontrolled hypertension.
- History of cerebrovascular accident within 6 months of enrollment.
- Myocardial infarction within 6 months prior to enrollment.
See the full eligibility criteria
- Male or female patients ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Advanced metastatic, recurrent, and unresectable solid tumor that has relapsed after ≥ one prior line of therapy.
- Subject must have received prior therapy with disease-specific regimens that have been established to convey a clinical benefit. Alternatively, subject must have been offered such regimens and provided written...
- Subject with solid tumors with genetic alterations and mutations (including but not limited to BRAF, BRCA, EGFR mutations, and ALK translocations) must have either received targeted therapy for such conditions or...
- Exposure to an anti-PD-(L)1 monoclonal antibody therapeutic in the most recent line of prior therapy.
- Documented refractory status to the most recent regimen, which must include an anti-PD-(L)1 monoclonal antibody, as defined by lack of response after at least two cycles of therapy or relapse within 12-months of...
- Solid tumor disease types that are eligible for enrollment consist of:
- head and neck cancer (squamous cell carcinoma of oral cavity, larynx, nasopharynx, and other sites);
- malignant melanoma;
- small cell carcinoma, thoracic and extra-thoracic; and,
- non-small cell lung cancer.
- Presence of measurable disease to permit monitoring by RECISTv1.1 Criteria.
- 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.
- Patients must be ≥ two weeks from last solid tumor cancer chemotherapy, major surgery, radiation therapy and/or participation in investigational trials.
- Patients must have recovered from clinical toxicities (resolution of CTCAE (v5) toxicity to a value of ≤ 2).
- Ejection fraction (EF) by MUGA or 2-D echocardiogram within institution normal limits, with an EF level of ≥ 40%.
- Calculated creatinine clearance of ≥ 60 mL/min/1.73 m\^2.
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 x upper limit of normal.
- ANC (Absolute neutrophil count) of ≥ 1500 cells/μL.
- Platelet count ≥ 100,000 cells/μL.
- Hemoglobin count ≥ 8 grams/μL.
- Bilirubin ≤ 1.5 mg/dL (except if due to Gilbert's disease).
- Corrected DLCO ≥ 50% (Pulmonary Function Test)
- No history of abnormal bleeding tendency (as defined by any inherited coagulation defect, or history of internal bleeding).
- Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without...
- Other active malignancy (except non-melanoma skin cancer).
- Life expectancy \< 4 months.
- Seropositivity for HIV, hepatitis B, or hepatitis C, unless such conditions are in stable condition using adequate treatment.
- Uncontrolled hypertension.
- History of cerebrovascular accident within 6 months of enrollment.
- Myocardial infarction within 6 months prior to enrollment.
- NYHA class III/IV congestive heart failure.
- Uncontrolled angina/ischemic heart disease.
- Cancer metastasis to the central nervous system, unless such metastasis has been adequately treated.
- Pregnant or breastfeeding patients.
- Patients of childbearing age, or males who have a partner of childbearing potential, who are unwilling to practice contraception.
- Patients may be excluded at the discretion of the PI or if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk.
The study team makes the final eligibility decision.
Where it's taking place
- Hackensack, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hackensack, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.