- |||||||||| Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, library TCR-T-cell therapy / Alaunos Therap
Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date, IO biomarker, Gene therapy, Metastases: Non-Viral TCR Gene Therapy (clinicaltrials.gov) - Mar 12, 2024
P2, N=0, Withdrawn,
N=210 --> 0 | Trial completion date: Dec 2029 --> Mar 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2028 --> Mar 2024
- |||||||||| library TCR-T-cell therapy / Alaunos Therap
hunTR™: a hyperplex platform for the discovery of neoantigen-reactive T-cell receptors (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_564;
In addition, hunTR is applicable for personalized TCR-T therapy such that most solid tumor patients could be eligible for mutation-targeted cell therapy. Ethics Approval Human-derived specimens were obtained through a commercial source that adheres to all applicable regulations and guidelines of the relevant countries including the US.
- |||||||||| Proleukin (aldesleukin) / Clinigen, Novartis, Prometheus, library TCR-T-cell therapy / Alaunos Therap
First-in-human phase 1/2 study of autologous T cells engineered using the Sleeping Beauty System transposon/transposase to express T-cell receptors (TCRs) reactive against cancer-specific mutations in patients with advanced solid tumors. (Available On Demand; 328b) - Apr 28, 2022 - Abstract #ASCO2022ASCO_1738;
P1/2
Given the number and complexity of different neoantigen/HLA combinations on solid tumors, a TCR library approach is warranted...During the Treatment Period, patients will undergo lymphodepletion with cyclophosphamide and fludarabine...In Arm B, if initiated by protocol, subjects will also receive aldesleukin (interleukin-2) infusion starting on Day 0 (within 24 hours of TCR-T cell product infusion) at 720K IU/kg, every eight hours for up to 4 days...Clinical and radiologic response will be assessed at 6 and 12 weeks after TCR-T cell drug product infusion and every 12 weeks thereafter until up to 2 years or study discontinuation (e.g., disease progression, initiation of new anti-cancer therapy, consent withdrawn), whichever occurs first. All subjects will continue to be followed in the Long-Term Follow-up Protocol for up to 15 years post-TCR-T cell drug product infusion.
- |||||||||| Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, library TCR-T-cell therapy / Alaunos Therap
Enrollment open, IO biomarker, Gene therapy, Metastases: Non-Viral TCR Gene Therapy (clinicaltrials.gov) - Feb 10, 2022
P2, N=210, Recruiting,
The TCR library directed against RAS hotspot mutations described here recognize RAS mutations found in about 45% of the Caucasian population and about 60% of the Asian population and represent promising reagents for "off-the-shelf" adoptive cell therapies (ACT). Suspended --> Recruiting
- |||||||||| Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, library TCR-T-cell therapy / Alaunos Therap
Trial suspension, IO biomarker, Gene therapy, Metastases: Non-Viral TCR Gene Therapy (clinicaltrials.gov) - Jan 26, 2021
P2, N=210, Suspended,
Suspended --> Recruiting Not yet recruiting --> Suspended
- |||||||||| Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, library TCR-T-cell therapy / Alaunos Therap
Enrollment open, IO biomarker, Gene therapy, Metastases: Non-Viral TCR Gene Therapy (clinicaltrials.gov) - Oct 15, 2019
P2, N=210, Recruiting,
Not yet recruiting --> Suspended Not yet recruiting --> Recruiting
- |||||||||| Proleukin (aldesleukin) / Merck (MSD), Novartis, Iovance Biotherap, library TCR-T-cell therapy / Alaunos Therap
New P2 trial, IO biomarker, Gene therapy, Metastases: Non-Viral TCR Gene Therapy (clinicaltrials.gov) - Sep 24, 2019
P2, N=210, Not yet recruiting,
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