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    8ms
    A Clinical Study of the Safety and Activity of the Investigational Cell Therapy NEO-PTC-01 in Patients With Advanced Melanoma (clinicaltrials.gov)
    P1, N=22, Terminated, BioNTech US Inc. | Trial completion date: Dec 2029 --> Mar 2025 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2029 --> Mar 2025; Sponsor decision
    Trial completion date • Trial termination • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221
    9ms
    Personalized, autologous neoantigen-specific T cell therapy in metastatic melanoma: a phase 1 trial. (PubMed, Nat Med)
    We designed BNT221, a personalized, neoantigen-specific autologous T cell product derived from peripheral blood, and tested this in a 3 + 3 dose-finding study with two dose levels (DLs) in patients with locally advanced or metastatic melanoma, disease progression after ICB, measurable disease (Response Evaluation Criteria in Solid Tumors version 1.1) and, where appropriate, BRAF-targeted therapy...Our results provide key insights into this neoantigen-specific adoptive T cell therapy and demonstrate proof of concept for this new therapeutic approach. ClinicalTrials.gov registration: NCT04625205 .
    P1 data • Journal • IO biomarker
    |
    BRAF (B-raf proto-oncogene) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    BNT221
    12ms
    A Clinical Study of the Safety and Activity of the Investigational Cell Therapy NEO-PTC-01 in Patients With Advanced Melanoma (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, BioNTech US Inc. | Trial completion date: Oct 2025 --> Dec 2029 | Trial primary completion date: Oct 2025 --> Dec 2029
    Trial completion date • Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221
    1year
    NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, BioNTech US Inc. | N=72 --> 22
    Enrollment change • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221
    1year
    NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P1, N=72, Active, not recruiting, BioNTech US Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221
    2years
    NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P1, N=72, Recruiting, BioNTech US Inc. | N=52 --> 72
    Enrollment change • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221
    over2years
    NTC-001: A phase I study to test safety and efficacy of BNT221, a non-engineered neoantigen-specific T cell product, in patients with advanced or metastatic melanoma (ESMO 2023)
    Conclusions In this first in human study, BNT221 as a single infusion therapy demonstrated a tolerable safety profile, product persistence, prolonged stable disease, and tumor regressions in patients with checkpoint inhibitor-resistant metastatic melanoma. Additional study is warranted and BNT221 combination with anti-PD-1 is currently underway.
    Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    BNT221
    over2years
    NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P1, N=52, Recruiting, BioNTech US Inc. | Trial primary completion date: Nov 2023 --> Oct 2025
    Trial primary completion date • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221
    almost3years
    NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P1, N=52, Recruiting, BioNTech US Inc. | Trial completion date: Nov 2023 --> Dec 2025
    Trial completion date • Metastases
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221
    over4years
    NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P1, N=52, Recruiting, BioNTech US Inc. | N=32 --> 52
    Clinical • Enrollment change
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221
    over4years
    [VIRTUAL] BNT221, an autologous neoantigen specific T cell product for adoptive cell therapy of metastatic melanoma (CIMT 2021)
    Conclusions NEO-STIM is a novel platform that is capable of generating ex vivo T cell responses to high-quality neoantigen- targets. A first in human study with this adoptive cell therapy, BNT221, in patients with metastatic melanoma is now underway.
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    BNT221
    5years
    NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma (clinicaltrials.gov)
    P1, N=32, Recruiting, BioNTech US Inc.
    Clinical • New P1 trial
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation
    |
    BNT221