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Malignant Solid TumorsPhase 1/2NCT06082557

A Study to Observe and Evaluate the Safety and Efficacy of T60c Injection for Treatment of Advanced Solid Tumor Patients

A Phase 1/2 study testing T60c injection in people with Malignant Solid Tumors, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an open-labeled, single-arm, multiple-dose escalation and single-dose expansion clinical study of cell therapy to observe and evaluate the safety and efficacy of T60c injection in the treatment of patients with advanced solid tumors Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Malignant Solid Tumors
What is being tested?
T60c injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
No sites listed yet
Study dates
Oct 2023to Jun 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 and ≤80 years old, gender is not limited;
  • Life expectancy>3 months;
  • The Eastern Oncology Consortium (ECOG) performance status from 0 to 1;
  • Subjects with malignant solid tumors confirmed by pathological diagnosis（who have failed or unable to tolerate in standard treatment(s), or haven't received standard treatment），including：
  • Breast cancer: including hormone receptor positive and triple negative breast cancer;
  • Non-small cell lung cancer, digestive system tumors (esophageal cancer, gastric cancer, colorectal cancer, pancreatic cancer), urinary system tumors (urothelial cancer, prostate cancer), gynecological tumors (cervical cancer, endometrial cancer, ovarian cancer). And the TROP-2 expression rate of tumor tissue in IHC (immuno-histochemistry) staining is ≥ 50%.
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  • The percentage of PD-1positive T lymphocytes in total T lymphocytes is more than 10%, and subjects should voluntarily receive peripheral blood mononuclear cell (PBMCs) apheresis collection.
  • At least one or more measurable lesions (CT slice thickness ≤ 5 mm, maximal diameter ≥ 10 mm, and lymph node with malignant metastasis minimal diameter of ≥15 mm) according by RECIST 1.1.
  • No serious hematological, hepatic, and renal function abnormalities, adequate function defined as :
  • Blood system (no blood transfusion or hematopoietic stimulating factor treatment within 14 days): Neutrophil count (ANC) ≥1.5×109/L, Platelet (PLT) ≥75×109/L, Hemoglobin (Hb) ≥80g/L, Lymphocyte count (LYM) ≥ 60%×lower limit of normal value;
  • Hepatic function: Total bilirubin (TBIL) ≤1.5×ULN, Alanine aminotransferase (ALT) ≤2.5×ULN,, Aspartate aminotransferase (AST) ≤5×ULN of patients with liver metastasis, Creatinine ≤1.5×ULN or creatinine clearance (eGFR) ≥60 mL/min (Cockcroft and Gault formula);
  • Blood coagulation function: Activated partial thrombin time (APTT) ≤1.5×ULN, International normalized ratio (INR) ≤1.5×ULN;
  • Eligible subjects (male or female) must comply with effective contraception methods (hormonal or barrier method or abstinence, etc.) during the trial period at least 90 days after T60c injection treatment; Female subjects of childbearing potential (definition refers to appendix) must undergo a pregnancy test (blood or urine) and the results must be negative within 7 days prior to first use of T60c injection.
  • Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.

Who cannot join

  • Subjects with symptomatic and/or untreated brain metastases (of any size and number); However, subjects may be eligible if they received documented treatment, and the intracranial lesion(s) remain stable for at least 2 months before starting screening;
  • Subjects suffered from other malignant tumors within two years prior screen or concurrent malignancy, except for basal cell skin cancer that has been cured, and in situ malignancies of cervical carcinoma or lung cancer;
  • Subjects received treatment with tislelizumab (excluding other PD-1 monoclonal antibodies) or any PD-L1 monoclonal antibody within the first 12 weeks of screening;
  • Subjects received systemic chemotherapy, radiotherapy, immunotherapy and targeted therapy within 2 weeks before screening; However, the restriction for Nitroso urea or Mitomycin C are within 6 weeks before screening;
  • Subjects received chronic systemic sex hormone treatment for any reason within 12 weeks before screening; However, the use of low-dose glucocorticoid replacement therapy due to adrenal cortex dysfunction is exempted.
  • Subjects received granulocyte Colony-stimulating factor (G-CSF) and Granulocyte-macrophage colony-stimulating factor (GM-CSF) for leukocytosis within 12 weeks before screening;
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  • Subjects received with Trop-2-targeted drug treatment previously;
  • Any active autoimmune disease or autoimmune disease in history, which is included but not limited to: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; and asthma requiring medical intervention by bronchiectasis, etc., except for vitiligo, psoriasis and alopecia without systemic treatment, well controlled type I diabetes, hypothyroidism with normal thyroid function after replacement therapy;
  • Recipients of any organ transplant, including allogeneic stem cell transplants, with exception of transplants requiring no immunosuppression (e.g., corneal transplants, hair transplants);
  • Subjects with any forms of primary immunodeficiency (e.g., severe combined immunodeficiency disease (SCID) and acquired immunodeficiency syndrome (AIDS);
  • Presence of major acute or chronic infections, including:
  • Viral hepatitis, including hepatitis B (HBsAg positive and/or hepatitis B DNA copy number higher than the lower detection threshold of the research center), Hepatitis C, etc.; HIV antibody test positive; Patients with positive Treponema pallidum antibodies;
  • Active bacterial or fungal infections that require systemic treatment;
  • Active tuberculosis infection with clinical symptoms, physical examination or imaging, and laboratory findings;
  • Acute exacerbation of chronic obstructive pulmonary disease or other respiratory diseases;
  • Cardiovascular/Cerebrovascular disease with clinical significance, such as cerebrovascular accident/stroke (<6 months before enrollment), myocardial infarction (<6 months before enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Class II) or severe arrhythmia;
  • Clinically uncontrollable serious cavity effusion which is judged by researchers as unsuitable for inclusion;
  • Subjects received any genetically modified cell therapy in the past;
  • Subjects need anticoagulant treatment (Warfarin or heparin);
  • Subjects need long-term antiplatelet therapy (including but not limited to: aspirin >300mg/d or clopidogrel >75mg/d, etc.);
  • Pregnant or lactating women;
  • Subjects with no/limited capacity for civil conduction, or mental disorders/ poor compliance;
  • Alcoholic or drug abuse;
  • Subjects or its families are incapable to understand the content and objectives of this clinical study;
  • Subjects with other serious or uncontrolled systemic diseases, or other conditions deemed unsuitable for participation in this clinical trial as judged by the investigator.

Trial locations and contacts

No sites are listed yet.

Bing He Xu, Doctor contact

+86 18730279296

xubinghe@cicams.ac.cn

About this study

Official title: A Clinical Study on the Observation and Evaluation on the Safety and Efficacy of T60c Injection in the Treatment of Patients With Advanced Solid Tumors

This is an open-labeled, single-arm, multiple-dose escalation and single-dose expansion clinical study of cell therapy to observe and evaluate the safety and efficacy of T60c injection in the treatment of patients with advanced solid tumors

Being tested
T60c injection

What participants receive

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

  • T60c injectionDrug

    Peripheral blood mononuclear cells (PBMCs) are used for cell preparation. PD-1 positive T cells are isolated from peripheral blood by blood cell apheresis method and transduced with lentivirus loaded with "enhanced receptor" and "TROP2-CAR" (TROP2-chimeric antigen receptor). The obtained T60c is used for one-time intravenous infusion.

Study groups in NCT06082557
Study groupRoleWhat they receive
All the subjects enrolled will receive the experimental intervention, T60c injectionExperimentalNot described
Receives: Drug: T60c injection

What is being measured

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

  1. Objective Response Rate（ORR）

    The number of cases with CR (complete remission) and PR (partial remission) accounted for the total number of evaluable cases

    Measured: 3 months after T60c transfusion

  2. Disease Control Rate(DCR)

    The number of cases with remission and stable lesions after treatment accounted for the total number of evaluable cases

    Measured: 3 months after T60c transfusion

Secondary outcomes (4)

  1. Progression-Free Survival(PFS)

    A time quantum from the day which subject received T60c transfusion to the day which subject was evaluated of the first disease progression or death due to any reasons.

    Measured: From the day of T60c transfusion until the day of first documented progression or death from any cause, whichever came first, assessed up to 27 months.

  2. Objective Response Rate（ORR）

    The number of cases with remission and stable lesions after treatment accounted for the total number of evaluable cases.

    Measured: through study completion, an average of 27 months.

  3. Duration of Response（DOR）

    A time quantum from the day which subject first evaluated as CR or PR to the day which subject was evaluated as PD (progressive disease) or death due to any reasons.

    Measured: From the day that the subject was first evaluated as CR or PR to the day which subject was evaluated as PD or death due to any reasons, assessed up to 27 months.

  4. Overall survival(OS)

    A time quantum from the day subject received T60c transfusion to death due to disease.

    Measured: From the day of T60c transfusion until the day of T60c transfusion to death due to disease, assessed up to 27 months.

Timeline

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

  1. First posted13 Oct 2023
  2. Study startOct 2023 (estimated)
  3. Primary completionMar 2025 (estimated)
  4. Study completionJun 2025 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06082557
Sponsor's protocol ID
T60c-017-2023
Status last verified
Oct 2023
First submitted
22 Sep 2023
Last updated
13 Oct 2023
Results posted
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 1/2 study testing T60c injection in people with Malignant Solid Tumors, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.

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 14 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Bing He Xu, Doctor (+86 18730279296, xubinghe@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate（ORR） (time frame: 3 months after T60c transfusion). 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 NCT06082557.

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 13 Oct 2023.

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