Health TrialsbyHealthPanel

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

ConditionsKRAS G12VKRAS G12DSolid Tumor
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • TCR-T cells

    Biological/Vaccine

    TCR-T cell injection will be administered intravenously after lymphodepletion.

  • Fludarabine

    Drug

    Fludarabine is used for lymphodepletion.

  • Cyclophosphamide

    Drug

    Cyclophosphamide is used for lymphodepletion.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: TCR-T cellsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Adverse Events (AEs)

Incidence and severity of adverse events

Time frame
1 year
2

Serious Adverse Events (SAEs)

Incidence and severity of serious adverse events

Time frame
1 year

Secondary outcomes

1

Objective Response Rate (ORR)

The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1

Time frame
1 year
2

Disease Control Rate (DCR)

The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1

Time frame
1 year
3

Duration of response (DOR)

DOR is defined as the time from the first evaluation of a tumor as CR or PR to the first evaluation as progressive disease (PD) or death from any cause

Time frame
1 year
4

Time to response (TTR)

TTR is defined as the time between cell infusion and initial disease assessment as CR or PR

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Shanghai Bintie Biotechnology Co., Ltd

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: