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TCR-T CellsEarly Phase 1KSH01-TCRTNCT05539833

KSH01-TCRT Solid Tumors

A Early Phase 1 study testing KSH01 injection in people with TCR-T Cells and Refractory Solid Tumors, run by TCRx Therapeutics Co.Ltd at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
KSH01 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
19 Aug 2022to 31 Jul 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  1. Inclusion Criteria:
  • 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;
  • Dose expansion phase: target-positive subjects who progressed on first-line therapy;
  • HLA-A*02 positive and tumor target positive (target tumor cell staining intensity is divided into 0, 1+, 2+, 3+, >30% of cancer cells express 2+ or 3+ positive positive for the target)
  • All toxicities caused by previous anti-tumor therapy were relieved to grade 0-1 (according to NCI CTCAE version 5.0) or to an acceptable level for inclusion/exclusion criteria. Except for other toxicities such as alopecia and vitiligo that the researchers believe do not pose a safety risk to the subjects;
  • Sufficient organ function (without receiving medical support such as blood transfusion and granulocyte colony-stimulating factor within 14 days before cell reinfusion), defined as follows:
  • Blood system:
  • 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);
  • Liver function:
  • Total bilirubin (TBIL) ≤ 2.0 × upper limit of normal (ULN), Gilbert disease subjects should be ≤ 3 × ULN;
  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤3×ULN (in the dose expansion phase, subjects with liver metastases or liver cancer can be ≤5×ULN); alkaline phosphatase (ALP) ≤2.5× ULN (subjects with bone metastases, 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)));
  • The qualitative urine protein is ≤1+; if the qualitative urine protein is ≥2+, a 24-hour urine protein quantitative examination is required, and if the 24-hour urine protein quantitative <1 g, it is acceptable;
  • Coagulation function: Those who did not receive anticoagulation therapy: International normalized ratio (INR), activated partial thromboplastin time (APTT) should be less than or equal to 1.5×ULN; patients with liver metastasis or liver cancer should be less than or equal to 2×ULN;
  • Physical status: Eastern Cooperative Oncology Group (ECOG) score of 0-1;
  • Expected survival period ≥ 12 weeks;
  • According to RECIST 1.1 criteria, there is at least one measurable lesion (dose expansion phase) or an evaluable lesion (dose escalation phase);
  • After assessment, enough PBMC cells can be collected in the subject to prepare autologous TCR-T cells;
  • After evaluation, the prepared autologous TCR-T cells are of sufficient quantity and qualified quality, and can be used for clinical reinfusion of the corresponding dose;
  • Female subjects with fertile potential have a negative blood pregnancy result within 3 days before the cell reinfusion, and are willing to abstain from sex or take medically approved high-efficiency drugs from the time of signing the informed consent to 6 months after the end of the last medication. contraceptive measures (eg, IUDs, condoms);
  • Male subjects are willing to keep abstinence or take medically approved high-efficiency contraceptive measures from the time of signing the informed consent to 6 months after the end of the last medication, and do not donate sperm during this period.
  • All subjects are required to provide tumor tissue specimens that can be used for target analysis, which must be archived specimens or fresh biopsy specimens (bone biopsy specimens are not accepted). Only those with positive target expression can enter the study.
  1. Exclusion Criteria:
  • History of severe allergic diseases, severe drug allergy (including unmarketed test drugs), or known allergy to any component of the recommended drugs (including pretreatment drugs) in this program;
  • Those who have received coronary artery reconstruction in the past;
  • Evidence of significant bleeding disorders or other significant bleeding risk:
  • History of intracranial hemorrhage or intraspinal hemorrhage;
  • Tumor lesions invade large blood vessels and have obvious bleeding risk;
  • Thrombosis or embolism occurred within 6 months before cell reinfusion;
  • Clinically significant hemoptysis or tumor hemorrhage occurred within 1 month before cell reinfusion;
  • Anticoagulant therapy for therapeutic purposes (except low molecular weight heparin) has been used within 2 weeks before cell reinfusion;
  • Antiplatelet drugs, such as aspirin (>325 mg/day), clopidogrel (>75 mg/day), dipyridamole, ticlopidine or cilostazine, were used within 10 days before cell reinfusion azoles, etc.;
  • Received the following treatments or drugs before cell reinfusion:
  • Unhealed wounds, ulcers or fractures within 28 days before cell reinfusion;
  • Inoculated with live attenuated vaccine within 28 days before cell reinfusion;
  • Received nitrosourea or mitomycin C treatment within 6 weeks before cell infusion; received oral fluorouracil treatment 2 weeks before cell infusion or within ●half-lives of the drug (whichever is longer) ;
  • Received corticosteroids within 2 weeks before cell reinfusion, or it is expected that corticosteroid treatment may be required during blood collection, cell collection or cell reinfusion; except for the following cases: short time (≤7 days), dose not higher than 10 mg/d prednisone or equivalent dose of corticosteroids for the prevention or treatment of non-autoimmune conditions; topical, intranasal, intraocular, intraarticular or inhaled corticosteroids;
  • Known leptomeningeal metastases, or uncontrolled or symptomatic central nervous system metastases manifested by clinical symptoms, cerebral edema, spinal cord compression, and/or progressive growth. Subjects with a history of central nervous system metastasis or spinal cord compression are acceptable if they have clearly received treatment and are clinically stable after 8 weeks of discontinuation of anticonvulsants and steroids before cell reinfusion;
  • The existence of any form of primary immunodeficiency;
  • There is any active autoimmune disease, or there is a history of autoimmune disease and relapse is expected (including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, need for bronchial Asthma subjects medically intervened with dilators, except for the following: type 1 diabetes; skin conditions not requiring systemic therapy [eg, vitiligo, psoriasis, alopecia]; hypothyroidism only receiving hormone replacement therapy; childhood Asthma in complete remission without any intervention in adulthood; or others not expected to relapse in the absence of external triggers);
  • Within 6 months before cell reinfusion, the following conditions have occurred: myocardial infarction, severe/unstable angina, clinically significant arrhythmia requiring clinical intervention, cerebrovascular accident/stroke, transient ischemic attack, Subarachnoid hemorrhage, cardiac insufficiency with New York Heart Association (NYHA) class ≥ II;
  • There is currently uncontrollable pleural, pericardial, and ascites effusion;
  • Before cell reinfusion, there are:
  • Congenital Long QT Syndrome
  • Use of a pacemaker
  • Left Ventricular Ejection Fraction (LVEF) < 50%
  • QTcF interval>480 msec (QTcF=QT/(RR^0.33))
  • Cardiac troponin I or T >2.0 ULN
  • Poorly controlled diabetes (fasting blood glucose ≥ 13.3 mM)
  • Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
  • Forced expiratory volume in the first second (FEV1) ≤ 60% or those who need supplemental oxygen therapy;
  • Unexplained fever >38.5°C during screening or before cell reinfusion (fever due to tumor can be included in the group as judged by the investigator);
  • Known history of allogeneic organ transplantation;
  • Known history of alcohol abuse, psychotropic substance abuse or drug abuse;
  • Have a clear history of neurological or mental disorders, such as epilepsy, dementia, schizophrenia, etc.;
  • Known to have acquired immunodeficiency syndrome (AIDS);
  • Known severe active viral, bacterial infection, or uncontrolled systemic fungal infection;
  • Positive virological test results (HIV, CMV, HSV, HPV, EBV, syphilis);
  • HBsAg positive or HBcAb positive, and HBV-DNA > 200 IU/mL; HCV-Ab positive, and HCV-RNA higher than the detection limit of the research center;
  • According to the judgment of the investigator, the underlying condition of the subject may increase the risk of receiving the experimental drug treatment, or cause confusion in the interpretation of the toxic reactions and adverse events;
  • Expected to receive any other form of antitumor drug treatment during the study period;
  • Women who are pregnant or breastfeeding;
  • Other investigators deem it inappropriate to participate in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

JingChao Liu contact

18115621929

liujc@tcrximmune.cn

China1 site, 1 recruiting

  • The first affiliated hospital of Guang Xi medical university

    Nanning, Guangxi, 530000

    JingChao Liu, 18115621929, liujc@tcrximmune.cn

    Recruiting

Other trials in China

About this study

Official title: A Single-arm, Prospective Clinical Study of KSH01-TCR-T in the Treatment of Refractory/Recurrent Solid Tumors

  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.
Being tested
KSH01 injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KSH01 injectionDrug

    TCR-T cell injection

Study groups in NCT05539833
Study groupRoleWhat they receive
TCR-T cellsExperimentalNot described
Receives: Drug: KSH01 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with treatment-related adverse events assessed by CTCAE v4.0.

    Subject safety

    Measured: about 2 years

  2. Changes in overall tumor diameter.

    tumor efficacy

    Measured: about 2 years

Secondary outcomes (5)

  1. Anti-tumor efficacy

    Subject survival time

    Measured: about 5 years

  2. Pharmacokinetic profile

    Pharmacokinetic Values of blood test values

    Measured: about 2 years

  3. Cytokine profile

    Cytokine values of blood test values

    Measured: about 2 years

  4. Biomarker Features profile

    Biomarker Features values of blood test values

    Measured: about 2 years

  5. Maximum tolerated dose in subjects.

    Subject safety

    Measured: about 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2022
  2. Study start19 Aug 2022
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05539833
Sponsor's protocol ID
KSH01-TCRT-01
Acronym
KSH01-TCRT
Status last verified
Oct 2026
First submitted
7 Sep 2022
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing KSH01 injection in people with TCR-T Cells and Refractory Solid Tumors, run by TCRx Therapeutics Co.Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact JingChao Liu (18115621929, liujc@tcrximmune.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related adverse events assessed by CTCAE v4.0. (time frame: about 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05539833.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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