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DRUG:

NeoTCR-P1

i
Other names: NeoTCR-P1, NeoTCR-P1 adoptive cell therapy, Autologous gene-edited TCR T cell product, Neoepitope specific adoptive T cell therapy, Neoantigen-targeted T cells therapy
Associations
Company:
PACT Pharma
Drug class:
TCR modulator, T lymphocyte replacement
Related drugs:
Associations
over1year
Monitoring of neoantigens and adoptively transferred personalized neoTCR T cell populations in the tumor and PBMCs of patients with solid tumors (AACR 2023)
Background: NeoTCR-P1 is a personalized autologous T cell therapy for treatment of patients with solid tumors... These case studies illustrate for the first time tracking of 3 unique personalized T cell products within a single patient. Shifts in the T cell phenotype of the neoTCR T cell products post-infusion for some, but not all, of the products suggest early signs of T cell engagement with the target.
Clinical • IO biomarker
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CD8 (cluster of differentiation 8) • GZMB (Granzyme B) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
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NeoTCR-P1
over2years
A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors (clinicaltrials.gov)
P1a/1b, N=21, Suspended, PACT Pharma, Inc. | Trial completion date: Dec 2024 --> Aug 2022 | Active, not recruiting --> Suspended | Trial primary completion date: Dec 2022 --> Aug 2022
Trial completion date • Trial suspension • Trial primary completion date • Combination therapy
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IL2 (Interleukin 2)
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Opdivo (nivolumab) • Proleukin (aldesleukin) • NeoTCR-P1
almost3years
A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors (clinicaltrials.gov)
P1a/1b, N=21, Active, not recruiting, PACT Pharma, Inc. | Recruiting --> Active, not recruiting | N=148 --> 21
Enrollment closed • Enrollment change • Combination therapy
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IL2 (Interleukin 2)
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Opdivo (nivolumab) • Proleukin (aldesleukin) • NeoTCR-P1
almost4years
A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors (clinicaltrials.gov)
P1a/1b, N=148, Recruiting, PACT Pharma, Inc. | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2021 --> Dec 2022
Clinical • Trial completion date • Trial primary completion date • Combination therapy
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IL2 (Interleukin 2)
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Opdivo (nivolumab) • Proleukin (aldesleukin) • NeoTCR-P1
over4years
[VIRTUAL] A high-throughput platform to produce neoE-HLA libraries for capturing neoE-specific T cells from the peripheral blood of patients with solid tumors (AACR-II 2020)
This fully personalized NeoTCR-P1 cell therapy is manufactured in fully enclosed, automatable systems for each individual patient with solid tumors. These breakthrough technologies support the on-going Phase 1 clinical trial of personalized engineered autologous NeoTCR-P1 T cell therapies for patients with six different solid tumor types (NCT03970382).
Clinical
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CD8 (cluster of differentiation 8)
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NeoTCR-P1
over4years
[VIRTUAL] A phase Ia/Ib, open-label first-in-human study of the safety, tolerability, and feasibility of gene-edited autologous NeoTCR-T cells (NeoTCR-P1) administered to patients with locally advanced or metastatic solid tumors. (ASCO 2020)
The combination of NeoTCR-P1 dosing plus nivolumab will be tested in a Phase 1b study. This is the first clinical study of an autologous, fully personalized adoptive T cell therapy directed against private tumor-exclusive mutations, generated without using recombinant viral vectors. Research Funding: PACT Pharma
Clinical • P1 data • PD(L)-1 Biomarker
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CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
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Opdivo (nivolumab) • NeoTCR-P1
over4years
[VIRTUAL] A Phase 1a/1b, open-label first-in-human study of the safety, tolerability, and feasibility of gene-edited autologous NeoTCR-T cells (NeoTCR-P1) administered to patients with locally advanced or metastatic solid tumors (AACR-I 2020)
This is the first clinical study of an autologous, fully personalized adoptive T cell therapy directed against private tumor-exclusive mutations, generated without using recombinant viral vectors.
Clinical • P1 data • PD(L)-1 Biomarker
|
CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
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Opdivo (nivolumab) • NeoTCR-P1