KSH01-R02-101 Solid Tumors

ConditionSolid Tumor
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTCRx Therapeutics Co.Ltd

About this trial

1. . safety and tolerance 2. . objective response rate

Eligibility criteria

Qualifiers

1) Voluntary participation in clinical research; Fully understand the study and voluntarily sign the informed consent form; Willing to follow and able to complete all test procedures;

2) Male or female, 18 to 70 years old (including boundary value);

3) Malignant solid tumors failed to receive standard treatment;

4) HLA-A * 02 is positive and tumor target is positive (the staining intensity of target tumor cells is divided into 0, 1+, 2+, 3+, and more than 30% of cancer cells express 2+or 3+positive as the target is positive)

Disqualifiers

6.1.1) Neutrophil count (ANC) is not lower than the lower limit of normal value of the center;

6.1.2) White blood cell (WBC) shall not be lower than the lower limit of normal value of the center;

6.1.3) Platelet count (PLT) shall not be lower than the lower limit of normal value of the center;

6.1.4) Hemoglobin (Hb) shall not be lower than 0.8 * LLN (lower limit of normal value);

Trial design

Treatments tested in this trial

  • KSH01 injection

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators