RE001 T Cell Injection for the Treatment of KRAS G12V Mutated Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHenan Cancer Hospital
About this trial
At present, there is an urgent need for new drugs for kirsten rat sarcoma viral oncogene (KRAS) mutant tumors in clinic. Preclinical studies support the specificity, safety and anti-tumor activity of RE001. Previous similar studies suggest the feasibility of T cell receptor engineered T cell therapy (TCR-T) treatment, and measures have been taken to ensure the safe administration of RE001 and the close monitoring and management of adverse events. To sum up, RE001 has controllable safety and anti-tumor activity on KRAS mutant solid tumor, which can be preliminarily studied to provide support for clinical research of patients with advanced solid tumor.
Eligibility criteria
Qualifiers
Subjects voluntarily participate in the study and sign informed consent;
Age ≥18 years old and ≤75 years old;
Advanced malignant solid tumors with clear pathological diagnosis;
Standard therapies failed or cannot be tolerated or lacks effective treatments;
Disqualifiers
Those who have received major surgery, conventional chemotherapy, large-area radiotherapy, immunotherapy or biological therapy anti-tumor treatment within 4 weeks before entering the trial;
Previous use of drugs targeting KRAS G12V mutations, including previous participation in cell therapy with similar targets Cellular testing and small molecule inhibitors targeting KRAS G12V mutations, etc.;
Allergic reactions are known to occur to any ingredient (such as dimethyl sulfoxide, cyclophosphamide, fludarabine) or structurally similar compounds treated in this trial;
Failure to recover from adverse reactions related to previous surgery or treatment to < Grade 2 CTCAEV5.0;
Trial design
Treatments tested in this trial
- RE001 T cell
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov