deltatrials
Recruiting PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT05144698

RAPA-201 Therapy of Solid Tumors

Phase I/II Trial of Autologous Rapamycin-Resistant Th1/Tc1 (RAPA-201) Cell Therapy of PD-(L)1 Resistant Solid Tumors

Sponsor: Rapa Therapeutics LLC

Conditions Esophageal Squamous Cell Carcinoma Head and Neck Cancer Malignant Melanoma Small Cell and Non-small Cell Lung Cancer Solid Tumor Squamous Cell Carcinoma of Larynx Squamous Cell Carcinoma of Nasopharynx Squamous Cell Carcinoma of Oral Cavity Squamous Cell Carcinoma of Other Specified Sites of Skin
Interventions Chemotherapy Prior to RAPA-201 Therapy Pembrolizumab (PD-1 Blocking Antibody) RAPA-201 Rapamycin Resistant T Cells
Updated 7 times since 2022 Last updated: May 9, 2025 Started: Aug 1, 2021 Primary completion: Jan 1, 2026 Completion: Dec 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE1/PHASE2 clinical study on Esophageal Squamous Cell Carcinoma and Head and Neck Cancer, this trial is actively recruiting participants. The trial is conducted by Rapa Therapeutics LLC and has accumulated 7 data snapshots since 2021. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2022 – ~Apr 2023 · 15 months · monthly snapshotRecruiting~Apr 2023 – ~Jul 2024 · 15 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotRecruiting~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshotRecruiting~Feb 2025 – ~May 2025 · 3 months · monthly snapshotRecruiting~May 2025 – ~Jun 2025 · 31 days · monthly snapshotRecruiting~Jun 2025 – present · 13 months · monthly snapshotRecruiting

Change History

7 versions recorded

  1. Jun 2025 — Present [monthly]

    Recruiting PHASE1/PHASE2

  2. May 2025 — Jun 2025 [monthly]

    Recruiting PHASE1/PHASE2

  3. Feb 2025 — May 2025 [monthly]

    Recruiting PHASE1/PHASE2

  4. Sep 2024 — Feb 2025 [monthly]

    Recruiting PHASE1/PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE1/PHASE2

    Phase: PHASE1_PHASE2 → PHASE1/PHASE2

▶ Show 2 earlier versions

  1. Apr 2023 — Jul 2024 [monthly]

    Recruiting PHASE1_PHASE2

    Phase: PHASE2 → PHASE1_PHASE2

  2. Jan 2022 — Apr 2023 [monthly]

    Recruiting PHASE2

    First recorded

Aug 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Rapa Therapeutics LLC
Data source: Rapa Therapeutics LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations