RAPA-201 Therapy of Solid Tumors

Launched by RAPA THERAPEUTICS LLC · Nov 22, 2021

Keywords

ClinConnect Summary

The RAPA-201 clinical trial is studying a new type of immunotherapy for patients with advanced solid tumors, including various types of lung, breast, gastric, and head and neck cancers, among others. This therapy uses specially modified immune cells, known as RAPA-201 cells, which are designed to better fight cancer. The goal of the trial is to see how effective this therapy is when combined with standard chemotherapy (carboplatin and paclitaxel) in patients whose cancer has not responded to previous treatments, particularly those involving a type of medication called PD-1 inhibitors.

To participate in this trial, patients must be at least 18 years old and have a specific type of solid tumor that has returned after at least one prior treatment. They should also have received prior therapy with an anti-PD-1 drug and show that their cancer is no longer responding to treatment. Participants will undergo six rounds of chemotherapy followed by the infusion of RAPA-201 cells. Throughout the trial, patients will be closely monitored for their response to the therapy as well as any potential side effects. This study is important because it seeks to find new ways to help patients whose cancers are resistant to current treatments, and it offers hope for better outcomes in a challenging situation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patients ≥ 18 years of age.
• • 2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• • 3. Advanced metastatic, recurrent, and unresectable solid tumor that has relapsed after ≥ one prior line of therapy.
• • 4. 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 documentation of refusal to receive such regimens.
• • 5. 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 provided written documentation of refusal to receive such regimens.
• • 6. Exposure to an anti-PD-(L)1 monoclonal antibody therapeutic in the most recent line of prior therapy.
• • 7. 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 initiation of anti-PD-(L)1-containing therapy.
• 8. Solid tumor disease types that are eligible for enrollment consist of:
• • 1. head and neck cancer (squamous cell carcinoma of oral cavity, larynx, nasopharynx, and other sites);
• • 2. malignant melanoma;
• • 3. small cell carcinoma, thoracic and extra-thoracic; and,
• • 4. non-small cell lung cancer.
• • 9. Presence of measurable disease to permit monitoring by RECISTv1.1 Criteria.
• • 10. 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.
• • 11. Patients must be ≥ two weeks from last solid tumor cancer chemotherapy, major surgery, radiation therapy and/or participation in investigational trials.
• • 12. Patients must have recovered from clinical toxicities (resolution of CTCAE (v5) toxicity to a value of ≤ 2).
• • 13. Ejection fraction (EF) by MUGA or 2-D echocardiogram within institution normal limits, with an EF level of ≥ 40%.
• • 14. Calculated creatinine clearance of ≥ 60 mL/min/1.73 m\^2.
• • 15. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 x upper limit of normal.
• • 16. ANC (Absolute neutrophil count) of ≥ 1500 cells/μL.
• • 17. Platelet count ≥ 100,000 cells/μL.
• • 18. Hemoglobin count ≥ 8 grams/μL.
• • 19. Bilirubin ≤ 1.5 mg/dL (except if due to Gilbert's disease).
• • 20. Corrected DLCO ≥ 50% (Pulmonary Function Test)
• • 21. No history of abnormal bleeding tendency (as defined by any inherited coagulation defect, or history of internal bleeding).
• • 22. 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 prejudice to future medical care.
• Exclusion Criteria:
• • 1. Other active malignancy (except non-melanoma skin cancer).
• • 2. Life expectancy \< 4 months.
• • 3. Seropositivity for HIV, hepatitis B, or hepatitis C, unless such conditions are in stable condition using adequate treatment.
• • 4. Uncontrolled hypertension.
• • 5. History of cerebrovascular accident within 6 months of enrollment.
• • 6. Myocardial infarction within 6 months prior to enrollment.
• • 7. NYHA class III/IV congestive heart failure.
• • 8. Uncontrolled angina/ischemic heart disease.
• • 9. Cancer metastasis to the central nervous system, unless such metastasis has been adequately treated.
• • 10. Pregnant or breastfeeding patients.
• • 11. Patients of childbearing age, or males who have a partner of childbearing potential, who are unwilling to practice contraception.
• • 12. 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.