Phase 2 Trial of Autologous Rapamycin-Resistant Th1/Tc1 (RAPA-201) Cell Therapy of PD-(L)1 Resistant Malignant Melanoma
Rapa Therapeutics LLC
Summary
The protocol is a Simon's 2-stage, non-randomized, open label, multi-site, phase 2 trial for patients with advanced metastatic, recurrent and unresectable malignant melanoma that has recurred or relapsed after prior anti-PD-(L)1 therapy.
Description
The therapy of solid tumors, including melanoma, 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 the PD-1/PD-L1 pathway \[PD-(L)1\] by administration of monoclonal antibodies. In this study, we 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 the therapy of malignant melanoma that is refractory to anti-PD-(L)1 therapy. RAPA-201 is a second-g…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female patients ≥ 18 years of age. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of ≥ 3 months. 3. Patients with unresectable or metastatic melanoma (Stage IIIc or Stage IV). 4. Prior to enrollment, 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 the anti-PD- (L)1-containing therapy. 5. For patients with BRAF V600 mutation-posi…
Interventions
- BiologicalRAPA-201 Rapamycin Resistant T Cells
Autologous Rapamycin-Resistant Th1/Tc1 Cells
- DrugChemotherapy Prior to RAPA-201 Therapy
Carboplatin + Paclitaxel Regimen (CP Regimen)
Location
- Hackensack University Medical CenterHackensack, New Jersey