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Advanced Solid TumorsEarly Phase 1NCT05194709

Study of Anti-5T4 CAR-NK Cell Therapy in Advanced Solid Tumors

A Early Phase 1 study testing Anti-CAR-NK Cells in people with Advanced Solid Tumors, run by Wuxi People's Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is an interventional, single arm, open-label, investigator-initiated trial (IIT) to evaluate the safety, tolerability, initial efficacy and pharmacokinetics (PK) of anti-5T4 CAR-NK cells in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Solid Tumors
What is being tested?
Anti-CAR-NK Cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
30 Dec 2021to 30 Dec 2022
Phase
Early Phase 1
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

  • Subjects volunteer to participate in this clinical study, are fully aware of the study and have signed the Informed Consent Form (ICF). Subjects are willing to follow and able to complete all trial procedures.
  • Age: adult at the age of 18-80 (both inclusive), female or male.
  • Patients with advanced malignant solid tumors, histologically or cytologically confirmed, who had failed standard therapy, or had no standard therapy, or were not eligible for standard therapy at this stage; tumor biomarkers combined with imaging can be used to diagnose some special advanced tumors.
  • Eastern Cooperative Oncology Group (ECOG) score ≤2 and expected survival time >3 months.
  • Organ function during screening should meet the following criteria:
  • Absolute neutrophil count (ANC)≥0.8×109/L
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  • Platelet (PLT)≥50×109/L
  • Hemoglobin (Hb)≥80g/L
  • Total bilirubin (TBIL)≤2×ULN
  • Alanine aminotransferase (ALT)≤3×ULN; Patients with liver metastasis or liver cancer: ≤5×ULN
  • Aspartate aminotransferase (AST)≤3×ULN; Patients with liver metastasis or liver cancer: ≤5×ULN
  • Creatinine (Cr)≤1.5× ULN
  • Creatinine clearance (Ccr) (to be calculated only when Cr > 1.5× ULN)>50ml/min/1.73m2 (Cockcroft-Gault formula)
  • Activated partial thrombin time (APTT)≤1.5×ULN
  • International normalized ratio (INR)≤1.5×ULN
  • Subjects of reproductive age and their partners should agree to have no family planning and to use effective contraceptive methods (hormonal or barrier methods or abstinence, etc.) for 6 months from signing the ICF until the last dose of the study drug is administered; women of reproductive age should not be pregnant or breastfeeding.

Who cannot join

  • Have received systemic antitumor therapy, including chemotherapy, immunotherapy, and radical radiotherapy, within 1 week prior to their first use of the study drug.
  • Have participated in other clinical trials and received any unmarketed investigational drug or treatment within 4 weeks prior to first use of the study drug.
  • Any prior adoptive cellular immunotherapy.
  • Have undergone major organ surgery (excluding needle biopsy or surgery related to this indication) within 4 weeks prior to their first use of the study drug, or required elective surgery during the study period.
  • Patients with severe infections that cannot be controlled.
  • Patients with a known history of human immunodeficiency virus (HIV) infection, or a history of organ transplantation.
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  • Have active autoimmune diseases or have had autoimmune diseases that are likely to recur (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, vasculitis, psoriasis, etc.). Except in the following cases: type 1 diabetes that was well controlled with hormone replacement therapy, hypothyroidism, skin conditions that did not require systemic therapy (e.g., vitiligo), and other conditions that were well controlled and that the investigator determined were less likely to recur (e.g., childhood asthma in remission).
  • Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
  • There are serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia, and Ⅱ-Ⅲ degree atrioventricular block, which need clinical intervention;
  • The mean QT interval corrected by Fridericia method (QTcF) is prolonged (male>450ms, female>470ms);
  • Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or above cardiovascular and cerebrovascular events occurring within 6 months before the first administration;
  • Patients with heart failure or left ventricular ejection fraction (LVEF) < 50% in the New York Heart Association (NYHA) classification ≥II;
  • Hypertension beyond clinical control.
  • Adverse effects of previous antineoplastic therapy have not returned to CTCAE grade 5.0≤2 (except for toxicity that the investigator determined to be of no safety risk, such as alopecia, hypothyroidism stabilized by hormone replacement therapy).
  • Central nervous system metastases with clinical symptoms.
  • Had other malignant tumors in the past 3 years, excluding skin basal cell carcinoma, ductal carcinoma in situ and cervical carcinoma in situ with a radical surgery.
  • Have a history of alcohol or drug abuse or mental disorder.
  • The investigator considered that the subjects had a history of other serious systemic diseases or other reasons that made them unsuitable for the study.

Trial locations and contacts

1 site in 1 country.

Peihua Lu, MD contact

+8613583991399

lyzlyylxm@163.com

China1 site, 1 recruiting

  • Wuxi People's Hospital

    Wuxi, Jiangsu

    Peihua Lu, MD, +8613583991399, lyzlyylxm@163.com

    Recruiting

Other trials in China

About this study

Official title: Clinical Trial of Anti-5T4 Oncofetal Trophoblast Glycoprotein (5T4) Conjugated Antibody Redirecting Natural Killer (CAR-NK) Cells in Advanced Solid Tumors

This study is an interventional, single arm, open-label, investigator-initiated trial (IIT) to evaluate the safety, tolerability, initial efficacy and pharmacokinetics (PK) of anti-5T4 CAR-NK cells in patients with advanced solid tumors.

Read the detailed description

The treatment cycle in this study is 21 days. The administration of CAR-NK cell will be performed on day 1 and day 3 of each cycle. Subjects will be treated continuously until the criteria for termination of treatment are met. In this study, the dose escalation design is adopted. The first administration dose in the first cycle is 3.0×10^9 cells. If no adverse events were observed, the second administration dose in the first cycle would be 4.0×10^9 cells, and each administration dose in the second cycle and thereafter would be 4.0×10^9 cells.

Being tested
Anti-CAR-NK Cells

What participants receive

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

  • Anti-CAR-NK CellsBiological

    The administration of CAR-NK cell will be performed on day 1 and day 3 of each cycle (21 days). The first administration dose in the first cycle is 3.0×10^9 cells. If no adverse events were observed, the second administration dose in the first cycle would be 4.0×10^9 cells, and each administration dose in the second cycle and thereafter would be 4.0×10^9 cells.

Study groups in NCT05194709
Study groupRoleWhat they receive
Anti-5T4 CAR-NK CellsExperimentalNot described
Receives: Biological: Anti-CAR-NK Cells

What is being measured

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

  1. Number of Adverse Events (AEs)

    To evaluate the safety and tolerability of anti-5T4 CAR-NK cells

    Measured: From day 1 to day 90 after the last dose

Secondary outcomes (6)

  1. Objective response rate (ORR)

    To determine the anti-tumor effectivity of anti-5T4 CAR-NK cells

    Measured: Up to 1 year after infusion

  2. Progression-free survival (PFS)

    To determine the anti-tumor effectivity of anti-5T4 CAR-NK cells

    Measured: Up to 1 year after infusion

  3. Overall survival (OS)

    To determine the anti-tumor effectivity of anti-5T4 CAR-NK cells

    Measured: Up to 1 year after infusion

  4. Disease control rate (DCR)

    To determine the anti-tumor effectivity of anti-5T4 CAR-NK cells

    Measured: Up to 1 year after infusion

  5. Cytokine release

    Blood samples will be collected at specified time points to detect the cytokine (IL-1β, IL-2, IL-4, IL-6, IL-10, IFN-γ, hsCRP) concentration (pg/mL)

    Measured: Up to 1 year

  6. Lymphocyte subtype

    Blood samples will be collected at specified time points to analyze the lymphocyte subtypes (CD3, CD4, CD8, CD19, CD56)

    Measured: Up to 1 year

Timeline

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

  1. First posted18 Jan 2022
  2. Study start30 Dec 2021
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Dec 2022 (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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05194709
Sponsor's protocol ID
IBR854-T01
Other IDs
WX-IBR-8
Status last verified
Jan 2022
First submitted
4 Jan 2022
Last updated
2 Feb 2022
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 Anti-CAR-NK Cells in people with Advanced Solid Tumors, run by Wuxi People's Hospital 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 16 inclusion and 18 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 2 Feb 2022. 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?

Results are not available in the source record.

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

Contact Peihua Lu, MD (+8613583991399, lyzlyylxm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse Events (AEs) (time frame: From day 1 to day 90 after the last dose). 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 NCT05194709.

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 2 Feb 2022.

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