Basic Information


GTO ID GTC0487
Trial ID NCT03970382
Disease Colorectal Cancer | Breast Cancer | Ovarian Cancer | Melanoma | Lung Non-Small Cell Carcinoma
Altered gene Neoantigen
Therapeutic/Target gene Target gene
TherapyTCR-T cell
Treatment Neoantigen TCR-T cells
HLAHLA class I
PhasePhase1
Recruitment statusSuspended
TitleA 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 as a Single Agent or in Combination With Anti-PD-1 to Patients With Locally Advanced or Metastatic Solid Tumors
Year2019
CountryUnited States
Company sponsorPACT Pharma, Inc.
Other ID(s)PACT-0101

Clinical Result

Cohort1: dose level 1
Administration route infusion
Dosage 0.2~5.4E9 cells
Donor type autologous
Pts 8
Age Adult, Older_Adult
Lymph depletion Yes
Adverse reactions 1/8(CRS)
References PMID: 36356599
Cohort2: dose level 2
Administration route infusion
Dosage 0.4~1.96E9 cells
Donor type autologous
Pts 3
Age Adult, Older_Adult
Lymph depletion Yes
Adverse reactions no TCR related AEs
References PMID: 36356599
Cohort3: dose level 3
Administration route infusion
Dosage 0.4~1.3E9 cells
Donor type autologous
Pts 2
Age Adult, Older_Adult
Lymph depletion Yes
Adverse reactions no TCR related AEs
References PMID: 36356599
Cohort4: dose level 4
Administration route infusion
Dosage 4E8 cells
Donor type autologous
Pts 1
Age Adult, Older_Adult
Lymph depletion Yes
Adverse reactions no TCR related AEs
References PMID: 36356599
Cohort5: dose level 5
Administration route infusion
Dosage 4E9 cells
Donor type autologous
Pts 1
Age Adult, Older_Adult
Lymph depletion Yes
Adverse reactions no TCR related AEs
References PMID: 36356599
Cohort6: dose level 6
Administration route infusion
Dosage 1.96E9 cells
Donor type autologous
Pts 1
Age Adult, Older_Adult
Lymph depletion Yes
Adverse reactions 1/1(encephalopathy)
References PMID: 36356599

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