Phase 2b of RAPA-201 Cell Therapy in Post-PD-(L)-1 Melanoma

NCT06708455 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

  • Malignant Melanoma With Metastasis
  • Malignant Melanoma
  • Malignant Melanoma Stage IIIc
  • Malignant Melanoma Stage IV

Interventions

BIOLOGICAL

RAPA-201 Rapamycin Resistant T Cells

Autologous Rapamycin-Resistant Th1/Tc1 Cells

DRUG

Chemotherapy Prior to RAPA-201 Therapy

Carboplatin + Paclitaxel Regimen (CP Regimen)

Sponsors & Collaborators

  • Rapa Therapeutics LLC

    lead INDUSTRY

Principal Investigators

  • Daniel Fowler, M.D. · Rapa Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-03-01
Primary Completion
2029-03-01
Completion
2029-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06708455 on ClinicalTrials.gov