TCR-T Cell Therapy for KRAS Mutation in Advanced Solid Tumors

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University

About this trial

This is a single-arm, Multicenter, open-label clinical study aimed at evaluating the safety and efficacy of TCR-T injection in patients with advanced solid tumors induced by KRAS mutations.

Eligibility criteria

Qualifiers

Voluntary signing of an informed consent form (ICF);

Males or females, aged 18-70 years (inclusive);

Subjects with advanced solid tumors confirmed by histology/cytology, have failed with standard treatment, or intolerant to standard treatment, or no standard treatment exists:1)Colorectal cancer:failed or intolerant to at least two lines of standard treatment.2)Non-small cell lung cancer:Absence of the following gene mutations (Epidermal Growth Factor Receptor[EGFR]、Anaplastic Lymphoma Kinase[ALK] 、 Proto-oncogene tyrosine-protein kinase 1[ROS1]) and having failed or intolerant to platinum-based chemotherapy and/or immunotherapy and/or anti-angiogenic therapy.3)Other advanced solid tumors:failed with standard treatment, or intolerant to standard treatment, or no standard treatment exist.

At least one measurable lesion (according to Response Evaluation Criteria in Solid Tumors[RECIST], version 1.1);

Disqualifiers

Other malignancies (except non-melanoma skin cancer with the disease-free survival of more than 5 years and cervical carcinoma in situ, bladder cancer, or breast cancer);

History of organ transplantation;

A history of mental disorders, which may affect compliance with this protocol or lead to failure in signing the ICF;

A history of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis and systemic lupus erythematosus) requiring systemic immunosuppressive/systemic disease-modulating drugs;

Trial design

Treatments tested in this trial

  • TCR-T cells
  • Fludarabine
  • Cyclophosphamide

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators

Sun Yat-sen University

Lead sponsor

Shanghai Bintie Biotechnology Co., Ltd

Collaborator