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Advanced Solid TumorPhase 1/2NCT05944185

Phase I/II Study of αPD1-MSLN-CAR T Cells in MSLN-positive Advanced Solid Tumors

A Phase 1/2 study testing αPD1-MSLN-CAR T Cells in people with Advanced Solid Tumor, run by Shanghai Cell Therapy Group Co.,Ltd at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

An open, multicenter, phase I/II study to evaluate the safety, tolerability, and effectiveness of αPD1-MSLN-CAR T cells in patients With MSLN-positive advanced solid tumors Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
αPD1-MSLN-CAR T Cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteChina
Study dates
Sep 2023to Sep 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have a histological or cytological diagnosis of advanced solid tumors#
  • Patients must have failed established standard medical anti-cancer therapies#
  • Greater than or equal to 18 years of age and less than or equal to 70 years of age on day of signing informed consent#
  • Life expectancy >3 months#
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
  • Subjects must meet blood coagulation parameters and have adequate venous peripheral access for apheresis. Patients must also have adequate mononuclear cells for CAR T cell manufacturing#
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  • Staining of MSLN must be greater than 50% of the cells in the tumor tissue and with apparent expression in the membrane. PD-L1 expression must be positive. Tissue obtained for the biopsy must be ≤1 year prior to enrollment for screening, not have been previously irradiated or exposed to chemotherapy. If unavailable, new tissue material from a recently obtained surgical or diagnostic biopsy is mandatory for this trial#
  • Satisfactory organ and bone marrow function as defined by the following:
  • Adequate bone marrow function in the opinion of the Investigator for lymphocyte-depleting chemotherapy: absolute neutrophil count must be greater than ≥ 1.5×109/L, lymphocyte count must be greater than ≥ 0.5×109/L, platelets must be greater than ≥ 90×109/ L, hemoglobin must be greater than ≥ 90g/L without transfusion within 7 days or dependency on EPO;
  • Total bilirubin must be less than or equal to two times (≤2.0x) the institutional normal upper limit; transaminases, serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST), must be less than or equal to 2.5 times (≤2.5x) the institutional normal upper limit (≤2.5x if there is hepatic metastasis);
  • Creatinine must be less than or equal to one and one half times (≤ 1.5x) the institutional normal upper limit or eGFR ≥ 60ml/ min/1.73m^2 [eGFR=186×#age#-0.203×SCr-1.154#mg/dl#,for female the eGFR shoud be timed by 0.742];
  • International normalized ratio (INR) or the PT is not greater than one and one half times (≤ 1.5) the upper limit of normal;
  • Lung function: ≤ CTCAE grade 1 dyspnea and SaO2≥ 91%
  • Cardiac function: cardiac ejection fraction (LVEF) must be greater than fifty percent (≥50%) by echocardiogram or MUGA one month before enrollment.
  • Subjects must have measureable disease as defined by RECIST 1.1 criteria;
  • Subjects sufficiently understand the trial and willingly sign the informed consent;
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  • For concurrent medication:
  • Systemic therapeutic corticosteroids must be stopped 72 hours before CAR-T infusion. However, patients using physiologic replacement doses of corticosteroids, or its equivalent, will be considered eligible;
  • Immunosuppressive therapy must be stopped within four (4) weeks prior to enrollment;
  • Male and Female subjects agree to use approved contraceptive methods (e.g. birth control pills, barrier device, intrauterine device, abstinence) during the study and for at least 12 months following the last dose of the study cell infusion and until no CAR-T cells can be detected after two consecutive PCR tests.

Who cannot join

  • Prior therapy with targeted therapy or cell therapy against MSLN#
  • Prior therapy with any gene therapy (including CAR-T cell therapy) or any T cell therapy home and abroad#
  • Active bacteria, viral or fungal infection, and not contained after antiinfective therapy (positive results in the blood ≤72 hours before infusion);
  • Patient is positive for Syphilis, Human Immunodeficiency Virus (HIV) , active Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA (qualitative) is detected);
  • Patient has a medical condition such as autoimmune disease or organ transplantation that requires chronic systemic steroid therapy or requires any other form of immunosuppressive medication;
  • History of severe cardiac or pulmonary disease, including hypertension that cannot be controlled by medication, and any of the conditions occurred within the past 6 months: congestive heart failure (New York Heart Association functional classification ≥3), cardiac angioplasty and stents, myocardial infarction, unstable angina, or other clinically significant heart disease#
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  • Detectable clinically relevant central nervous system (CNS) metastases and/or pathology such as epilepsy/seizure, brain Ischemia/ hemorrhage, dementia, cerebellar disease, or autoimmune disease affecting central nervous system#
  • Patient has a history or current evidence of any condition such as neurotic, psychiatric, immune, metabolic and infectious disease, on any therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator#
  • Patient has a known history of a hematologic malignancy, or of another malignant primary solid tumor concurrently, with the exception of :
  • Patients with in situ cervical cancer or breast cancer with no evidence of disease for ≥ 3 years after curative treatments;
  • Patients who underwent successful definitive resection of in situ cancer with no evidence of disease for ≥5 years;
  • Has had chemotherapy, radioactive, small molecules, biological cancer therapy, immunotherapy or other investigational drugs within 4 weeks prior to the initiation of the study#
  • Pregnant or breastfeeding women;
  • Investigators think that patient has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study and cooperation with the requirements of the trial, uncontrolled medical, psychological, familial, sociological, or geographical conditions, or is not in the best interest of the patient to participate.

Trial locations and contacts

1 site in 1 country.

Jie Wang contact

13910704669

zlhuxi@163.com

Jianchun Duan contact

13811259820

China1 site

  • National Cancer Center Cancer Hospital Chinese Academy of Medical Sciences

    Beijing

    Jie Wang, 13811259820, zlhuxi@163.com

Other trials in China

About this study

An open, multicenter, phase I/II study to evaluate the safety, tolerability, and effectiveness of αPD1-MSLN-CAR T cells in patients With MSLN-positive advanced solid tumors

Being tested
αPD1-MSLN-CAR T Cells

What participants receive

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

  • αPD1-MSLN-CAR T CellsDrug

    αPD1-MSLN-CAR T Cells

Study groups in NCT05944185
Study groupRoleWhat they receive
CAR T cellsExperimentalNot described
Receives: Drug: αPD1-MSLN-CAR T Cells

What is being measured

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

  1. Phase Ib: Incidence of Treatment Related adverse events (AEs)

    Incidence of treatment related AEs, AEs of special interest and serious adverse events(SAEs).

    Measured: Up to 12 months

  2. Phase Ib: Identification of Maximum Tolerated Dose (MTD)

    Incidence of dose-limiting toxicities (DLTs)

    Measured: day1-day28

  3. Phase II: Objective Response Rate (ORR), as assessed by IRC

    The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.

    Measured: Up to 12 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 Jul 2023
  2. Study startSep 2023 (estimated)
  3. Primary completionSep 2024 (estimated)
  4. Study completionSep 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
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05944185
Sponsor's protocol ID
BZDS1901-CTP-I/II-01
Status last verified
Jul 2023
First submitted
6 Jul 2023
Last updated
14 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing αPD1-MSLN-CAR T Cells in people with Advanced Solid Tumor, run by Shanghai Cell Therapy Group 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 21 inclusion and 14 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 14 Jul 2023. 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 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 Jie Wang (13910704669, zlhuxi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib: Incidence of Treatment Related adverse events (AEs) (time frame: Up to 12 months). The study lists 3 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 NCT05944185.

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 14 Jul 2023.

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