NW-301 TCR-T in Patients With Advanced Solid Tumor

ConditionTumor, Solid
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPeking University

About this trial

An open label, two cohorts, multiple dose exploratory clinical study to independently evaluate the safety, efficacy, and pharmacokinetics of autologous anti-KRAS G12V/G12D mutation T-cell Receptor T cell in advanced solid tumor

Eligibility criteria

Qualifiers

Aged 18 to 75 years, male or female; Subjects with pathologically confirmed Pancreatic Cancer and Colorectal Cancer and Lung Adenocarcinoma Cancer and have been failed to stand of care systemic treatment or have been untolerated to stand of care systemic treatment; HLA-A*11:01 positive Tumor tissue samples. sample was positive for KRAS G12V or G12D mutation; Estimated life expectancy > 12 weeks; According to the RECIST 1.1, there is at least one measurable tumor lesion; ECOG physical status score 0 ~ 1; Sufficient venous access for mononuclear cell collection (abbreviation: apheresis) Subjects should have adequate organ functions before screening and pre-treatment (at baseline).

Disqualifiers

Received the following therapy/treatment : Cytotoxic chemotherapy within 1 week prior to leukapheresis or lymphodepleting chemotherapy , Immune therapy (including monoclonal antibody therapy, checkpoint inhibitors) within 2 weeks prior to leukapheresis and within 1 week prior to lymphodepleting chemotherapy Corticosteroids within 2 weeks prior to leukapheresis and within 72 hrs prior to lymphodepleting chemotherapy Immunosuppressive drugs within 2 weeks prior to leukapheresis and within 1 week prior to lymphodepleting chemotherapy Tyrosine kinase inhibitor (TKI) (e.g. pazopanib) within 1 week prior to leukapheresis and within 1 week prior to lymphodepleting chemotherapy KRAS G12V mutation targetted therapy prior to leukapheresis and lymphodepleting chemotherapy in KRAS G12V mutation cohort KRAS G12D mutation targetted therapy prior to leukapheresis and lymphodepleting chemotherapy in KRAS G12D mutation cohort Anti-cancer Vaccine, Gene therapy using an integrating vector , Investigational treatment or interventional clinical trial prior to leukapheresis and lymphodepleting chemotherapy Major surgery prior to leukapheresis History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study.

Trial design

Treatments tested in this trial

  • NW-301V
  • Drug: NW-301D

Treatment groups

44 Participants
are divided into 2 treatment groups

Sponsors and collaborators