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Intrahepatic CholangiocarcinomaPhase 1/2NCT03633773

Safety and Efficacy Evaluation of MUC-1 CART in the Treatment of Intrahepatic Cholangiocarcinoma

A Phase 1/2 study testing MUC-1 CART cell immunotherapy in people with Intrahepatic Cholangiocarcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Intrahepatic cholangiocarcinoma (ICC) is one of the most common liver malignancies. Surgical treatment is the first choice. However, for patients without surgical indications, the benefits of conventional chemoradiotherapy are limited. CART is one of the fastest developed treatments in recent years. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Intrahepatic Cholangiocarcinoma
What is being tested?
MUC-1 CART cell immunotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
1 Jul 2018to 31 Dec 2024
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-65 years old.
  • The expression of ST glycosylated MUC-1 was more than 1+ in immunohistochemistry(IHC) by applicant-approved laboratory.
  • Histopathology or cytology confirmed intrahepatic cholangiocarcinoma.
  • Patients who are unable to perform surgery or are not suitable for surgery, or who have recurrence after surgery, or who are unwilling to undergo chemotherapy.
  • With at least one extracranial measurable lesion according to RECIST 1.1 edition.
  • The expected survival time is more than 60 days.
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  • The main organs are functional and meet the following criteria:
  • 1) ECOG physical fitness score was 0~1 or KPS score >70. 2) Routine blood tests were in accordance with the following criteria: HB (>90 g/L) (no blood transfusion within 14 days), ANC (>1.5 x10^9/L), PLT (> 80 x10^9/L), lymphocyte (> 0.7 x10^9/L), LY (> 15%), Alb (> 2.8 g/dL), serum lipase and amylase < 1.5^ULN (upper limit of normal value).
  • 3) Biochemical examination should meet the following criteria: TBIL < 1.5x ULN (upper limit of normal value); ALT < 2.5 xULN; serum Cr<1 xULN; endogenous creatinine clearance > 50ml/min (Cockcroft-Gault formula).
  • 4) Cardiac ejection fraction >55%. 8. No active hemorrhagic disease or severe coagulation dysfunction. 9. No allergy to the contrast media. 10. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days before enrollment, and the results are negative, and are willing to use appropriate contraception methods during the experiment and 8 weeks after the last CART.
  • 11. The volunteers voluntarily joined the study, signed informed consent, and had good compliance and follow-up.

Who cannot join

  • The transduction efficiency of T cells was <10% or T cells expanded less than 5 times after culture.
  • Chimeric antigen receptor therapy or other transgenic T cell therapy.
  • Pregnant or lactating women.
  • In the first 4 weeks before the start of the study, they took part in other drug clinical trials.
  • Patients with hypertension who can not be well controlled by a single antihypertensive drug (SBP> 140 mmHg, DBP> 90 mmHg), myocarditis or congenital heart disease, myocardial ischemia or infarction above grade I, arrhythmia above grade I (including QT interval < 440 ms) or cardiac insufficiency.
  • Long term unhealed wounds or fractures.
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  • With a history of psychotropic substance abuse and unable to quit or have a history of mental disorders.
  • Past and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc.
  • With uncontrollable fungi, bacteria, viruses or other infections, or need antibacterial treatment. The presence of simple urinary tract infections and uncomplicated bacterial pharyngitis is allowed after consultation with a medical supervisor, if there is a response to active therapy.
  • According to the NCI-CTCAE 4.0 standard, the patients who had used chemotherapy in the past had grade 2 hematological toxicity or grade 3 non-hematological toxicity.
  • With a history of HIV or hepatitis B or hepatitis C virus infection.
  • There are any indwelling catheters or drainage tubes (e.g. percutaneous nephrostomy, Frey's catheter, bile drainage or pleural/peritoneal/pericardial catheter). The use of dedicated central venous catheters is permitted.
  • With brain metastases.
  • With a history or disease of CNS, such as epileptic seizures, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS.
  • With a major immunodeficiency.
  • The main therapeutic drugs in this study (including fludarabine, cyclophosphamide, sodium mesylate, tropizumab and anti-infective drugs used during pretreatment) had a history of severe hypersensitivity.
  • In the first 6 months of admission, there was a history of deep venous thrombosis or pulmonary embolism.
  • History of autoimmune diseases (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that cause terminal organ injury or require systemic immunosuppressive/systemic disease-regulating drugs.
  • With any diseases that may interfere with the safety or efficacy of treatment.

Trial locations and contacts

1 site in 1 country.

Tingbo Liang, MD PhD contact

8613666676128

liangtingbo@zju.edu.cn

Qi Zhang, MD contact

8613819137113

zhangqi86@gmail.com

China1 site, 1 recruiting

  • The second affiliated hospital of Zhejiang University

    Hangzhou, Zhejiang, 310009

    Qi Zhang, MD, 8613819137113

    Recruiting

Other trials in China

About this study

Intrahepatic cholangiocarcinoma (ICC) is one of the most common liver malignancies. Surgical treatment is the first choice. However, for patients without surgical indications, the benefits of conventional chemoradiotherapy are limited. CART is one of the fastest developed treatments in recent years. MUC-1 CART can target abnormal glycosylation of MUC-1 and then killing tumor specifically. Here, investigators intend to evaluate the safety and efficacy of MUC-1 CART in intrahepatic cholangiocarcinoma.

Read the detailed description

Investigators chose MUC-1 positive intrahepatic cholangiocarcinoma patients with one measurable lesion at least. After general assessment, MUC-1 CART treatment was given to the participants. Objective remission rate, disease control rate, duration of overall response, progression-free survival, overall survival, drugs related side effects and other endpoints events were recorded and analyzed, to assess the MUC-1 CART could or couldn't effectively control the progress of intrahepatic cholangiocarcinoma.

Being tested
MUC-1 CART cell immunotherapy
Keywords
ICC, Mucin-1, CAR-T, Immunotherapy
Medical subject headings
Cholangiocarcinoma, Medullary cystic kidney disease 1

What participants receive

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

  • MUC-1 CART cell immunotherapyBiological

    After fludarabine and cyclophosphamide pre-chemotherapy，MUC-1 CART immunotherapy is given. A decent interval later, levels of specific antibodies, CART cells and serum cytokines will be assessed.

Study groups in NCT03633773
Study groupRoleWhat they receive
MUC-1 CARTExperimentalPatients are given fludarabine and cyclophosphamide as pretreatment before MUC-1 CART immunotherapy. After treatment, specific antibodies, CART cells and serum levels of cytokines will be assessed.
Receives: Biological: MUC-1 CART cell immunotherapy

What is being measured

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

  1. Disease control rate

    Percentage of patients whose cancer doesn't progress after treatment

    Measured: Up to approximately 12 months

Secondary outcomes (9)

  1. Objective response rate

    Percentage of patients whose cancer shrinks or disappears after treatment

    Measured: Up to approximately 12 months

  2. Duration of overall response

    The time of initial response until documented tumor progression.

    Measured: Up to approximately 12 months

  3. Progression-free survival

    The percentage of people does not get worse for a period of time after diagnosis

    Measured: Up to approximately 12 months

  4. Overall survival

    The percentage of people still alive for a given period of time after diagnosis

    Measured: Up to approximately 12 months

  5. Common Toxicity Criteria for Adverse Effects

    According to Common Toxicity Criteria for Adverse Effects version 4

    Measured: Up to approximately 12 months

  6. EORTC QLQ - PAN26

    Assessed by the European Organization for Research and Treatment of Cancer Quality of Life

    Measured: Up to approximately 12 months

  7. Anti-MUC1 CART cell antibody

    Serum level of anti-MUC1 CART cell antibody

    Measured: Up to approximately 12 months

  8. MUC1 CART cell

    Serum level of MUC-1 CART cell

    Measured: Up to approximately 12 months

  9. Related cytokine

    Serum level of related cytokine(like IL-2、IL-6、TNF-α、IFNγ and so on)

    Measured: Up to approximately 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 posted16 Aug 2018
  2. Study start1 Jul 2018
  3. Primary completion31 Aug 2023 (estimated)
  4. Study completion31 Dec 2024 (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
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03633773
Sponsor's protocol ID
SAHZJU-Y2018-078
Status last verified
Aug 2018
First submitted
14 Aug 2018
Last updated
22 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MUC-1 CART cell immunotherapy in people with Intrahepatic Cholangiocarcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 11 inclusion and 19 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 22 Aug 2018. 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 Tingbo Liang, MD PhD (8613666676128, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease control rate (time frame: Up to approximately 12 months). 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 NCT03633773.

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 22 Aug 2018.

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