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Research Study Utilizing Expanded Multi-antigen Specific Lymphocytes for the Treatment of Solid Tumors

Study acronym: REST
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Completion date: Dec 2025 to Dec 2027v14
  2. Minor Primary completion date changed from estimate of Sep 2024 to Apr 18, 2022 Start date: Nov 2016 to Oct 12, 2016v13 Show 1 more changeShow less
    • Start date: Nov 2016 to Oct 12, 2016
  3. Notable Primary completion date: Sep 2023 to Sep 2024 Completion date: Dec 2024 to Dec 2025v12 Show 1 more changeShow less
    • Completion date: Dec 2024 to Dec 2025
  4. Notable Primary completion date: Sep 2022 to Sep 2023 Completion date: Dec 2023 to Dec 2024v11 Show 1 more changeShow less
    • Completion date: Dec 2023 to Dec 2024
  5. Minor Re-verified, no change to tracked fieldsv10
Show 8 earlier versionsHide 8 earlier versions
  1. Minor Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 32 to confirmed 28 · Site details revisedv9 Show 2 more changesShow less
    • Enrollment target: estimated 32 to confirmed 28
    • Site details revised
  2. Minor Re-verified, no change to tracked fieldsv8
  3. Notable Primary completion date: Sep 2020 to Sep 2022 Completion date: Dec 2020 to Dec 2023 · Eligibility criteria expanded, about 35 words · Study description expanded, about 22 words · 1 morev7 Show 4 more changesShow less
    • Completion date: Dec 2020 to Dec 2023
    • Eligibility criteria expanded, about 35 words
    • Study description expanded, about 22 words
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  4. Notable Primary completion date: May 2019 to Sep 2020 Completion date: Apr 2020 to Dec 2020v6 Show 1 more changeShow less
    • Completion date: Apr 2020 to Dec 2020
  5. Minor Start date: Oct 2016 to Nov 2016 Secondary endpoints: details revised at 1 of 1 entry · Study description shortened, about 72 words · Eligibility criteria shortened, about 5 wordsv5 Show 3 more changesShow less
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description shortened, about 72 words
    • Eligibility criteria shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  6. Minor Eligibility criteria shortened, about 2 wordsv4 See this version in full on ClinicalTrials.gov ↗
  7. Minor Re-verified, no change to tracked fieldsv3
  8. Notable Trial status: Not Yet Recruiting to Recruiting Start date: Jun 2016 to Oct 2016 · Study sites: 0 to 1v2 Show 2 more changesShow less
    • Start date: Jun 2016 to Oct 2016
    • Study sites: 0 to 1
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Patients with high-risk solid tumors, those that are refractory to standard up front therapy or relapse after completion of therapy, have a very poor prognosis despite attempts to induce remission with salvage regimen. Novel therapies are critical for this patient population with high-risk cancer. The ability of tumors to be recognized and lysed by the immune system offers a unique opportunity to aid in tumor eradication by expanding and activating these anti-tumor cells. Through this ability to harness sophisticated and specific immunotherapy, residual or relapsed disease that is resistant to chemotherapy and/or radiotherapy could be eradicated. Prior studies have suggested both safety of expanded specific T cells and efficacy in the setting of melanoma, lymphoma or viral eradication. While this therapy has previously been limited by the versatility of the tumor to down-regulate antigens and evade a single immune-target, the use of multi-antigen specific T cells may permit better and more durable anti-tumor immunity. Thus, the investigators propose to infuse these specific multi-antigen anti-tumor T lymphocytes into patients with high risk solid tumors. This trial will be conducted to demonstrate safety of these cells and generate efficacy and biology data that may be important for future studies that may enhance tumor immunotherapy.
Trial Details
NCT Number NCT02789228
Lead Sponsor Children's National Research Institute
Conditions Solid Tumors
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov