KSH01-TCRT Solid Tumors
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTCRx Therapeutics Co.Ltd
About this trial
1\) Safety and efficacy of TCR-T cells in subjects with refractory/relapsed solid tumors. 2) The activation and proliferation of TCR-T cells in the subject, and the survival time.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily participate in clinical research; fully understand this research and sign informed consent voluntarily; be willing to follow and have the ability to complete all experimental procedures;
Male or female, aged 18 to 70 years (inclusive);
Subjects with advanced malignant solid tumors confirmed by histology or cytology;
Dose escalation phase: subjects who have no standard treatment, or who have failed or relapsed after standard treatment, or who cannot tolerate standard treatment with positive target expression;
Disqualifiers
The neutrophil count (ANC) is not lower than the lower limit of the normal value of the center;
White blood cells (WBC) are not lower than the lower limit of the normal value of the center;
Platelet count (PLT) is not lower than the lower limit of normal value in our center;
Hemoglobin (Hb) not less than 0.8*LLN (lower limit of normal);
Trial design
Design model
Single group
Treatments tested in this trial
KSH01 injection
DrugTCR-T cell injection
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: TCR-T cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with treatment-related adverse events assessed by CTCAE v4.0.
Subject safety
Time frame
about 2 years2
Changes in overall tumor diameter.
tumor efficacy
Time frame
about 2 yearsSecondary outcomes
1
Anti-tumor efficacy
Subject survival time
Time frame
about 5 years2
Pharmacokinetic profile
Pharmacokinetic Values of blood test values
Time frame
about 2 years3
Cytokine profile
Cytokine values of blood test values
Time frame
about 2 years4
Biomarker Features profile
Biomarker Features values of blood test values
Time frame
about 2 yearsSponsors and contacts
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Source ClinicalTrials.gov