T Cell Receptor Gene-Engineered T Cell Therapy Targeting KRAS Mutations in the Treatment of Subjects With Advanced Solid Tumor

ConditionTumor, Solid
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTao Zhang

About this trial

An open label, two-cohort, dose-escalation clinical study to evaluate the safety, anti-tumor activity and pharmacokinetics/pharmacodynamic (PK/PD) of NW-301V and NW-301D in subjects with advanced solid tumor.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18-75 years

Diagnosis of pathologically or histologically confirmed unresectable or advanced solid tumor, and have no standard treatment options available or unable to tolerate the currently available standard treatments

HLA-A*11:01positive

Tumor has KRAS G12V (NW-301V cohort) or G12D (NW-301D cohort) mutation

Disqualifiers

Received the following treatments: Cytotoxic chemotherapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Treatment with antibodies (including but not limited to those with monoclonal antibodies and immune checkpoint inhibitors) or other biologic therapy within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion; Immunosuppressive agents (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutic agents, mycophenolate mofetil, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL-6, or anti-IL-6 receptor) within 2 weeks prior to apheresis and within 1 week prior to lymphodepletion

History of allergic reactions to cyclophosphamide, fludarabine, or any other chemical or biological components of the drugs used in this study

History of chronic or recurrent severe autoimmune disease, or active immune disease requiring treatment with steroids or other immunosuppressive agents within 1 year prior to enrollment

Have symptomic CNS metastases

Trial design

Design model

Parallel

Treatments tested in this trial

  • NW-301V

    Drug

    TCR-T cell targeting KRAS G12V mutation

  • NW-301D

    Drug

    TCR-T cell targeting KRAS G12D mutation

Treatment groups

9 Participants
are divided into 2 treatment groups
Group A: NW-301VExperimental treatment 1 intervention
Group B: NW-301DExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

Safety

Time frame
28 days of single infusion

Secondary outcomes

1

Objective response rate (ORR)

Complete response (CR) and partial response (PR) based on best overall response (BOR), locally assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Time frame
through the completion of the study, with average of 2 years
2

Duration of response (DOR)

CR and PR, locally assessed using RECIST v1.1

Time frame
through the completion of the study, with average of 2 years

Other outcomes

Sponsors and contacts

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

Tao Zhang

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Sponsor institution

Neowise Biotechnology

Collaborator