Solid TumorEarly Phase 1NCT05580796

KSH01-R02-101 Solid Tumors

A Early Phase 1 study testing KSH01 injection in people with Solid Tumor, 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 tolerance 2. . objective response rate Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Solid Tumor
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: 11 Oct 2022to 11 Oct 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

Who may be able to join

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)
5). All toxic reactions caused by previous anti-tumor treatment are alleviated to grade 0-1 (according to NCI CTCAE version 5.0) or to an acceptable level of inclusion/exclusion criteria. Other poisons such as alopecia and vitiligo that researchers believe do not pose a safety risk to subjects
6) 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:

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6.1) Blood system:
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);
6.2) Liver function:
6.2.1) Total bilirubin (TBIL) ≤ 2.0 × Upper limit of normal (ULN), Gilbert disease subjects should be ≤ 3 × ULN；
6.2.2) 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）；
6.3) Renal function:
6.3.1) 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));
6.3.2) 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;
6.4) 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；
7) Physical condition: The score of the Eastern American Cooperative Oncology Group (ECOG) was 0-1;
8) Expected survival time ≥ 12 weeks;
9) According to RECIST 1.1, there is at least one measurable lesion (dose expansion stage) or evaluable lesion (dose increase stage);
10) After evaluation, enough PBMC cells can be collected from the subjects to prepare autologous TCR-T cells;
11) After evaluation, the prepared autologous TCR-T cells are sufficient in quantity and qualified in quality, and can be used for clinical reinfusion of corresponding dose;
12) The blood pregnancy result of female subjects with fertility within 3 days before cell transfusion was negative, and they were willing to sign informed consent from the end of the last medication to 6 months, keep abstinence or take medically approved effective contraceptive measures (such as intrauterine device, pregnancy avoidance device);
13) Male subjects are willing to keep abstinence or take medically approved effective contraceptive measures within 6 months from signing the informed consent form to the end of the last medication, and do not donate sperm during this period;
14) All subjects should provide tumor tissue samples that can be used for target analysis, which should be archived samples or fresh biopsy samples (bone biopsy samples are not accepted). Only those with positive target expression can enter the study.

Who cannot join

1) History of serious allergic diseases, allergic history of serious drugs (including non marketed test drugs) or known allergy to any component of the proposed drugs (including pre-treatment drugs) in this protocol;
2) Previous coronary artery reconstruction;
3) Evidence of major haemorrhagic disorder or other obvious bleeding risks:
3.1) Previous history of intracranial hemorrhage or intracerebral hemorrhage;
3.2) The tumor focus invades large vessels and has obvious risk of bleeding;
3.3) Thrombosis or embolism occurred within 6 months before cell transfusion;

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3.4) Clinically significant hemoptysis or tumor hemorrhage occurred within 1 month before cell transfusion;
3.5) Anticoagulant therapy (except low molecular weight heparin) for therapeutic purposes was used within 2 weeks before cell transfusion;
3.6) Within 10 days before cell reinfusion, they have used antiplatelet drugs, such as aspirin (>325 mg/day), clopidogrel (>75 mg/day), dipyridamole, ticlopidine or cilostazol;
4) Have received the following treatments or drugs before cell reinfusion:
4.1) Unhealed wound, ulcer or fracture within 28 days before cell reinfusion;
4.2) Inoculate live attenuated vaccine within 28 days before cell reinfusion;
4.3) The cells were treated with nitrosourea or mitomycin C within 6 weeks before reinfusion; Oral fluorouracil therapy was received 2 weeks before cell reinfusion or within 5 half lives of the drug (whichever is longer);
4.4) Within 2 weeks before cell reinfusion, the patient has received corticosteroids, or it is estimated that corticosteroids may be required during blood collection, cell collection or cell reinfusion; Except for the following cases: short-term (≤ 7 days) prednisone with a dose not higher than 10 mg/d or equivalent dose is used to prevent or treat non autoimmune conditions; Corticosteroids for local, nasal, intraocular, articular cavity or inhalation;
5) It is known that there is leptomeningeal metastasis, or uncontrolled or symptomatic central nervous system metastasis, with clinical symptoms, brain edema, spinal cord compression and/or progressive growth. Subjects with a history of central nervous system metastasis or spinal cord compression can be accepted if they have definitely received treatment and stopped using anticonvulsants and steroids 8 weeks before cell reinfusion, and their clinical manifestations are determined to be stable by the investigator;
6) Presence of any form of primary immunodeficiency;
7) Presence of any active autoimmune disease, Or asthmatic subjects who have a history of autoimmune diseases and are expected to relapse (including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, and asthma requiring medical intervention with bronchodilators. The following cases are excluded: type 1 diabetes; skin diseases that do not require systemic treatment [such as vitiligo, psoriasis, alopecia] ； Hypothyroidism requiring only hormone replacement therapy; Asthma that has been completely relieved in childhood does not need any intervention in adulthood; Or other patients who are expected to have no relapse under the condition of no external trigger);
8) Within 6 months before cell reinfusion, the following conditions occurred: myocardial infarction, severe/unstable angina, arrhythmia with clinical significance and requiring clinical intervention, cerebrovascular accident/stroke, transient ischemic attack, subarachnoid hemorrhage, and cardiac insufficiency with NYHA grade ≥ II;
9) At present, there are uncontrollable pleural, pericardial and peritoneal effusion;
10) Before cell reinfusion, there were:
10.1) congenital long QT syndrome
10.2) pacemaker use
10.3) left ventricular ejection fraction (LVEF)<50%
10.4) QTcF interval>480 msec (QTcF=QT/(RR ^ 0.33)
10.5) cardiac troponin I or T>2.0 ULN
10.6) poorly controlled diabetes mellitus (fasting glucose ≥ 13.3 mM)
10.7) poorly controlled hypertension (systolic pressure ≥ 160 mmHg and/or diastolic pressure ≥ 100 mmHg);
10.8) Forced expiratory volume in the first second (FEV1) ≤ 60% or oxygen therapy is required;
11) During screening or before cell reinfusion, fever of unknown cause occurred>38.5 ° C (according to the judgment of the investigator, fever caused by tumor can be included in the group);
12) History of allograft transplantation is known;
13) Known history of alcohol abuse, psychotropic substance abuse or drug abuse;
14) Have a clear history of neurological or mental disorders, such as epilepsy, dementia, schizophrenia, etc;
15) Known to have acquired immunodeficiency syndrome (AIDS);
16) Serious active virus, bacterial infection or uncontrolled systemic fungal infection are known;
17) Virology test results (HIV, CMV, HSV, HPV, EBV, syphilis) are positive;
18) HBsAg positive or HBcAb positive, and HBV-DNA>200 IU/mL; HCV Ab is positive, and HCV RNA is higher than the lower detection limit of the research center;
19) According to the judgment of the investigator, the basic condition of the subject may increase the risk of receiving the test drug treatment, or the interpretation of the toxic reaction and adverse event may cause confusion;
20) It is expected to receive any other form of anti-tumor drug treatment during the study period;
21) Women in pregnancy or lactation;
22) Other investigators consider 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

Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, 100000
JingChao Liu, 18115621929, liujc@tcrximmune.cn
Recruiting

Other trials in China

About this study

Official title: Investigator Initiated Clinical Trial on the Tolerance, Safety and Preliminary Efficacy of KSH01-TCRT Injection in Solid Tumor Subjects

. safety and tolerance
. objective response rate

Read the detailed description

. To evaluate the safety and tolerance of autologous TCR-T cells in target positive solid tumor patients.
. Preliminary evaluation of objective response rate (ORR) of autologous TCR-T cells in target positive solid tumor patients (such as esophageal cancer, gastric cancer, head and neck cancer, bladder cancer, melanoma, sarcoma, etc.)

Conditions: Solid Tumor
Being tested: KSH01 injection
Keywords: Genetic engineering of T-cells

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 NCT05580796
Study group	Role	What they receive
TCR-T cells	Experimental	TCR-T cell injection Receives: Drug: KSH01 injection

What is being measured

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

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.
Measured: 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.).
Measured: about 3 years

Secondary outcomes (5)

Maximum tolerable dose values
Maximum tolerable dose values
Measured: about 3 years
Changes in tumor size and time.
Preliminary evaluation of anti-tumor efficacy of autologous TCR-T cells in solid tumor subjects
Measured: about 5 years
Concentration of pharmacokinetic values in plasma
To evaluate the pharmacokinetics of autologous TCR-T cells in solid tumor subjects
Measured: about 3 years
Concentration of cytokine level value in plasma
To evaluate the cytokine level of autologous TCR-T cells in solid tumor patients during treatment
Measured: about 3 years
Concentration of biomarker value in plasma
Evaluation of biomarker characteristics of autologous TCR-T cells in solid tumor subjects
Measured: about 3 years

Timeline

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

11 Oct 202211 Oct 2027

First posted14 Oct 2022
Study start11 Oct 2022
Primary completion11 Oct 2027 (estimated)
Study completion11 Oct 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid TumorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: NCT05580796
Sponsor's protocol ID: KSH01-R02-101
Status last verified: Oct 2026
First submitted: 8 Oct 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

Interested in taking part?

JingChao Liu

18115621929

liujc@tcrximmune.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 1
A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
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RecruitingPhase 1
Personalized KXV01 Lentinvivo (TCR) Injection as the Therapy for Advanced Solid Tumors
Advanced Solid Tumors
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigator Initiated Clinical Trial on the Tolerance, Safety and Preliminary Efficacy of KSH01-TCRT Injection in Solid Tumor Subjects
ClinicalTrials.gov ID: NCT05580796
Acronym / sponsor ID: KSH01-R02-101
Conditions: Solid Tumor
Keywords: Genetic engineering of T-cells
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 50 participants (estimated)
Lead sponsor: TCRx Therapeutics Co.LtdIndustry (pharma, biotech, devices)
Study start: 11 Oct 2022 (actual)
Primary completion: 11 Oct 2027 (estimated)
Study completion: 11 Oct 2027 (estimated)
First posted: 14 Oct 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

. safety and tolerance
. objective response rate

Detailed description

. To evaluate the safety and tolerance of autologous TCR-T cells in target positive solid tumor patients.
. Preliminary evaluation of objective response rate (ORR) of autologous TCR-T cells in target positive solid tumor patients (such as esophageal cancer, gastric cancer, head and neck cancer, bladder cancer, melanoma, sarcoma, etc.)

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TCR-T cells	Experimental	Drug: KSH01 injectionTCR-T cell injection

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (26 listed)

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)
5). All toxic reactions caused by previous anti-tumor treatment are alleviated to grade 0-1 (according to NCI CTCAE version 5.0) or to an acceptable level of inclusion/exclusion criteria. Other poisons such as alopecia and vitiligo that researchers believe do not pose a safety risk to subjects

Key exclusion criteria (40 listed)

1) History of serious allergic diseases, allergic history of serious drugs (including non marketed test drugs) or known allergy to any component of the proposed drugs (including pre-treatment drugs) in this protocol;
2) Previous coronary artery reconstruction;
3) Evidence of major haemorrhagic disorder or other obvious bleeding risks:
3.1) Previous history of intracranial hemorrhage or intracerebral hemorrhage;
3.2) The tumor focus invades large vessels and has obvious risk of bleeding;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KSH01 injectionTCR-T cell injection	Drug	TCR-T cells

Primary outcome

Number of participants in treatment related adverse events assessed by CTCAE v4.0
Time frame: about 3 years
To evaluate the safety and tolerance of autologous TCR-T cells in target positive solid tumor subjects.
objective remission rate
Time frame: about 3 years
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.).

5 secondary outcomes

Maximum tolerable dose values
Time frame: about 3 years
Changes in tumor size and time.
Time frame: about 5 years
Concentration of pharmacokinetic values in plasma
Time frame: about 3 years
Concentration of cytokine level value in plasma
Time frame: about 3 years
Concentration of biomarker value in plasma
Time frame: about 3 years

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
Individual participant dataSharing planned: No

Related trials for Solid Tumor

RecruitingPhase 1
A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
RecruitingPhase 1
Personalized KXV01 Lentinvivo (TCR) Injection as the Therapy for Advanced Solid Tumors
Advanced Solid Tumors
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

JingChao Liu contact

18115621929

liujc@tcrximmune.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing KSH01 injection in people with Solid Tumor, 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?

The sponsor lists 26 inclusion and 40 exclusion criteria. 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 in treatment related adverse events assessed by CTCAE v4.0 (time frame: about 3 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 NCT05580796.

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.