KSH01-R02-101 Solid Tumors

NCT05580796 | Recruiting Early Phase 1

• 1 other identifier: KSH01-R02-101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor

Keywords

Genetic engineering of T-cells

Outcome Measures

Primary Outcomes (2)

• Number of participants in treatment related adverse events assessed by CTCAE v4.0

  To evaluate the safety and tolerance of autologous TCR-T cells in target positive solid tumor subjects.

  about 3 years

• objective remission rate

  To preliminarily evaluate the objective remission rate of autologous TCR-T cells in the treatment of target positive solid tumor subjects (such as esophageal cancer, gastric cancer, head and neck cancer, bladder cancer, melanoma, sarcoma, etc.).

  about 3 years

Secondary Outcomes (5)

• Maximum tolerable dose values

  about 3 years

• Changes in tumor size and time.

  about 5 years

• Concentration of pharmacokinetic values in plasma

  about 3 years

• Concentration of cytokine level value in plasma

  about 3 years

• Concentration of biomarker value in plasma

  about 3 years

Study Arms (1)

TCR-T cells

EXPERIMENTAL

TCR-T cell injection

Drug: KSH01 injection

Interventions

KSH01 injection DRUG

TCR-T cell injection

TCR-T cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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;
• \) Male or female, 18 to 70 years old (including boundary value);
• \) Malignant solid tumors failed to receive standard treatment;
• \) 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)

You may not qualify if:

• \) There is sufficient organ function (no medical support such as blood transfusion and granulocyte colony stimulating factor within 14 days before cell transfusion), which is defined as follows:
• ) Blood system:
• ) Neutrophil count (ANC) is not lower than the lower limit of normal value of the center;
• ) White blood cell (WBC) shall not be lower than the lower limit of normal value of the center;
• ) Platelet count (PLT) shall not be lower than the lower limit of normal value of the center;
• ) Hemoglobin (Hb) shall not be lower than 0.8 \* LLN (lower limit of normal value);
• ) Liver function:
• ) Total bilirubin (TBIL) ≤ 2.0 × Upper limit of normal (ULN), Gilbert disease subjects should be ≤ 3 × ULN；
• ) AST, ALT ≤ 3 × ULN (in the dose expansion stage, the subjects with liver metastasis or liver cancer can be ≤ 5 × ULN）； Alkaline phosphatase (ALP) ≤ 2.5 × ULN (bone metastasis subject, ALP ≤ 5 × ULN）；
• ) Renal function:
• ) Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 ml/min (Cockcroft Gault formula: (\[140 age\] × Weight \[kg\] × \[0.85 for women only\])/(72 × Creatinine (mg/dl));
• ) Qualitative urine protein ≤ 1+; If the urine protein is qualitative ≥ 2+, a 24-hour urine protein quantitative test is required. If the 24-hour urine protein quantitative test is less than 1 g, it is acceptable;
• ) Coagulation function: those not receiving anticoagulation treatment: International normalized ratio (INR), activated partial thromboplastin time (APTT) should be ≤ 1.5 × ULN； Subjects with liver metastasis or liver cancer should be ≤ 2 × ULN；
• \) Physical condition: The score of the Eastern American Cooperative Oncology Group (ECOG) was 0-1;
• \) Expected survival time ≥ 12 weeks;

Sponsors & Collaborators

• TCRx Therapeutics Co.Ltd: lead

Study Sites (1)

Chinese People's Liberation Army (PLA) General Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Central Study Contacts

clinical trials ksh

CONTACT

18994103369; ksh-clinicalt@tcrximmune.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2022
• First Posted: October 14, 2022
• Study Start: October 11, 2022
• Primary Completion: October 11, 2025
• Study Completion (Estimated): October 11, 2027
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)