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Advanced Solid Tumor CancerPhase 1YK1101NCT07139067

Phase I Clinical Study of YK1101 Injection for the Treatment of Advanced Solid Tumors

A Phase 1 study testing YK1101 cells in people with Advanced Solid Tumor Cancer, run by Peking University at 2 sites 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
Search all trials

Trial summary

A single-arm, open-label, dose exploratory study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-MAGE-A4 T cell receptor-engineered T cell (TCR-T) in advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor Cancer
What is being tested?
YK1101 cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesChina
Study dates
27 Apr 2025to 1 Jul 2028
Phase
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily willing to participate in the study and sign the written informed consent form
  • Age ≥18 years and ≤75 years,male or female .
  • Human leukocyte antigen (HLA)-A*11:01 matched
  • Fresh or formalin-fixed paraffin-embedded (FFPE) samples, immunohistochemistry(IHC)-stained MAGE-A4 positive（+2，≥30%）
  • Histologically-confirmed recurrent/metastatic advanced solid tumors，have failed or relapsed with the standard regimen, or have not tolerated the standard treatment regimen.Including but not limited to synovial sarcoma, myxoid liposarcoma, urothelial carcinoma, esophagogastric junction carcinoma, ovarian carcinoma, esophageal squamous carcinoma, head and neck tumor, non-small cell lung squamous carcinoma, triple negative breast cancer, etc.
  • Patients must have at least one measurable lesion defined by RECIST 1.1.
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  • No systemic anti-tumor therapy received within 2 weeks prior to peripheral blood mononuclear cell (PBMC) collection.
  • European Cooperative Oncology Group (ECOG) ≤1 and expected survival time ≥3 months at screening, 24 hours prior to apheresis (APH), lymphodepletion (LD), and infusion
  • Blood oxygen saturation (finger oxygen detection)≥ 95% in a calm and non oxygenated state.
  • Patients must meet the following criteria at screening and before preconditioning (baseline). If any laboratory test result is abnormal referring to the following criteria, it is acceptable to test one more time within 1week. If the test result is still abnormal, the patient is screen failed:
  • 1）Hematology (no intensive blood transfusion (≥2 times within 1week), platelet transfusion or cell growth factor (except for recombinant erythropoietin) performed within 7days before the test): neutrophils (NE) ≥1.5×109 per liter, lymphocytes (LY) ≥0.5×109per liter (except for before preconditioning), platelets (PLT) ≥75×109per liter and hemoglobin (Hb) ≥8.0 g/dL.
  • 2）Blood chemistry: creatinine clearance ≥40 mL/min, alanine aminotransferase (ALT) ≤2.5×ULN, aspartate aminotransferase (AST) ≤2.5×ULN, total bilirubin (TB) ≤1.5×ULN（Gilbert syndrome or liver metastasis subjects ≤ 3 × ULN）, serum lipase and amylase <1.5 ULN, alkaline phosphatase (ALP) ≤2.5 ULN; for patients with bone or hepatic metastasis, AST, ALT and ALP <5ULN.
  • 3）Prothrombin time ≤ULN+4 seconds. 11. Women of childbearing potential must have negative serum pregnancy test result at screening and before preconditioning and agree to use an effective and reliable contraceptive method for at least 1 year after the last study treatment. Te acceptable methods include bilateral tubal ligation/bilateral salpingectomy or bilateral tubal occlusion; any approved oral, injection or implantation of hormone; or barrier contraceptive method: condoms containing spermicidal .

Who cannot join

  • Pregnant or lactating women.
  • HIV, treponema pallidum or HCV serology is positive.
  • Patients with any uncontrolled active infection, including, but not limited to, active tuberculosis or HBV infection (HBsAg positive or HBV DNA positive).
  • Patients with symptomatic central nervous metastases.
  • Patients with AEs induced by previous treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤1, except for alopecia and other tolerable events judged by the investigator or permitted laboratory abnormalities according to the protocol.
  • Patient allergic or intolerant to preconditioning drugs, including, but not limited to, fudarabine and cyclophosphamide ; allergic to the components of YK1101; penicillin allergy history confrmed by positive skin test; or any severe allergy history-for example, anaphylactic shock.
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  • Patients who have undergone coronary artery reconstruction in the past.
  • The patient's tumor lesion invades large blood vessels and has a significant risk of bleeding.
  • Thrombosis and embolism occurred 6 months before cell transfusion.
  • Patients who have undergone major surgery or severe trauma within 4weeks before apheresis .
  • Patients who have a history of organ transplantation or are waiting for organ transplantation.
  • Patients with other serious diseases that may restrict them from participating in this study, such as poorly controlled diabetes (glycosylated hemoglobin HbA1c >8% undertreatment), poorly controlled hypertension judged by the investigator (blood pressure >160mmHg/100mmHg), severe cardiac insufficiency (left ventricular ejection fraction <50%), myocardial infarction or unstable arrhythmia or unstable angina pectoris, pulmonary embolism, chronic obstructive pulmonary disease, interstitial lung disease or clinically significant lung function test abnormalities in the past 6months.
  • Patients who are expected to continue using immunosuppressive therapy during the trial (excluding physiological replacement therapy with glucocorticoids, such as prednisone<10mg/d or equivalent doses)
  • Patients who require long-term use of aspirin or anticoagulant drugs.
  • Patients who have participated in other intervention clinical trials within 2 weeks.
  • Patients with adverse drug addiction or a history of drug abuse.
  • Patients who are unable or unwilling to comply with the clinical protocol, by the investigator's judgment.

Trial locations and contacts

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

Lin Shen contact

（86）10-88196561

linshenpku@163.com

China2 sites, 2 recruiting

  • Department of GI Oncology, Peking University Cancer Hospital Recruiting Beijing, Beijing, China, 100142

    Beijing

    Lin Shen Shen, MD,phD, (86)10-88196561, linshenpku@163.com

    Lin Shen, MD,phD

    Not yet recruiting

  • Peking University Cancer Hospital & Institute

    Beijing

    Recruiting

Other trials in China

About this study

A single-arm, open-label, dose exploratory study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-MAGE-A4 T cell receptor-engineered T cell (TCR-T) in advanced solid tumors.

Read the detailed description

This study is a single-arm, open-label, dose escalation/dose regimen finding study to assess the safety and pharmacokinetics of T-cell receptor-engineered T cell (TCR-T) targeting melanoma-associated antigen-4 (MAGE-A4) and to obtain the preliminary efficacy results in subjects who have been diagnosed with advanced solid tumors with positive MAGE-A4 expression.

Being tested
YK1101 cells
Keywords
Biological: TCR-T therapy, Phase I

What participants receive

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

  • YK1101 cellsBiological

    Drug: Fludarabine + Cyclophosphamide

Study groups in NCT07139067
Study groupRoleWhat they receive
YK1101 cellsExperimentalBiological: YK1101 cells Drug: Fludarabine + Cyclophosphamide
Receives: Biological: YK1101 cells

What is being measured

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

  1. Dose-limiting toxicity (DLT)

    Dose-limiting toxicity

    Measured: 28 days

  2. Treatment related AEs

    Treatment related AEs

    Measured: 28 days

Secondary outcomes (4)

  1. Antitumor efficacy-Objective response rate (ORR)

    The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%).

    Measured: 2 years

  2. Antitumor efficacy-Progression-free survival (PFS)

    The period from the day when the subject receives the infusion of cells to the first recorded tumor progression (whether treated or not) or death of any cause, which occurs first.

    Measured: 2 years

  3. Antitumor efficacy-Overall survival (OS)

    The period from the first infusion to any cause of death

    Measured: 2 years

  4. Antitumor efficacy-Duration of response (DOR)

    The period from the first evaluation of CR or PR to the first evaluation of PD or death of any cause

    Measured: 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 posted24 Aug 2025
  2. Study start27 Apr 2025
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Jul 2028 (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
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07139067
Sponsor's protocol ID
YK1101
Acronym
YK1101
Status last verified
Jun 2025
First submitted
18 Aug 2025
Last updated
24 Aug 2025
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 Phase 1 study testing YK1101 cells in people with Advanced Solid Tumor Cancer, run by Peking University at 2 sites 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 13 inclusion and 17 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 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Lin Shen (（86）10-88196561, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: 28 days). 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 NCT07139067.

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 24 Aug 2025.

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