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Lung Neoplasm MalignantPhase 1/2NCT03525782

Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for NSCLC

A Phase 1/2 study testing CAR-T Cells, CAR-T combining PD-1 Knockout and PD-1 knockout in people with Lung Neoplasm Malignant and Non-small Cell Lung Cancer, run by The First Affiliated Hospital of Guangdong Pharmaceutical University at 3 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The study is to assess the safety and efficacy of the anti-MUC1 CAR T cells and /or PD-1 knockout engineered T cells for patients with advanced non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
CAR-T Cells, CAR-T combining PD-1 Knockout and PD-1 knockout
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
3 sitesChina
Study dates
1 Feb 2018to 31 Jan 2022
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

  • MUC1 is expressed in malignancy tissues by immuno-histochemical (IHC).
  • Eastern cooperative oncology group (ECOG) performance status of 0-1 or karnofsky performance status (KPS) score is higher than 60.
  • Patients have a life expectancy > 12 weeks.
  • Adequate venous access for apheresis or venous sampling, and no other contraindications for leukapheresis.
  • Negative pregnancy test for females of child-bearing potentials.
  • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase < 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.
  • Signed informed consent form.

Who cannot join

  • Number of T cells is less than 10% or the amplification of the T cells via artificial antigen presenting cell (aAPC) stimulation is less than 5 times.
  • Patients with symptomatic central nervous system (CNS) involvement.
  • Pregnant or nursing women.
  • Known HIV infection.
  • Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
  • History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin.
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  • Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
  • Previously treatment with any gene therapy products.
  • The existence of unstable or active ulcers or gastrointestinal bleeding. Patients with portal vein vascular invasion or extrahepatic, are excluded from this study.
  • Patients with a history of organ transplantation or are waiting for organ transplantation.

Trial locations and contacts

3 sites in 1 country.

China3 sites, 3 recruiting

  • First Affiliated Hospital of Guangdong Pharmaceutical University

    Guangzhou, Guangdong, 510080

    Guobiao Huang, 86-20-39352064, 153706227@qq.com

    Recruiting

  • Professor Size Chen

    Guangzhou, Guangdong, 510080

    Size Chen, MD,PhD, +8613720956393, 13720956393@139.com

    Zhizhou Huang, MSc, +8613268258980, hzhizhou@sina.com

    Recruiting

  • Professor Size Chen

    Guangzhou, Guangdong, 510080

    Size Chen, MD,PhD, +8613720956393, 13720956393@139.com

    Yiguang Lin, MD, PhD

    Recruiting

Other trials in China

About this study

Official title: A Clinical Study of Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for Patients With Advanced Non-small Cell Lung Cancer

The study is to assess the safety and efficacy of the anti-MUC1 CAR T cells and /or PD-1 knockout engineered T cells for patients with advanced non-small cell lung cancer.

Read the detailed description

This is a combined phase 1 and 2 clinical study. The study is to assess the safety and efficacy of the anti-MUC1 CAR T cells and /or PD-1 knockout engineered T cells for patients with advanced non-small cell lung cancer. The treatment outcomes will be compared.

Being tested
CAR-T Cells, CAR-T combining PD-1 Knockout, PD-1 knockout, PD-1 mAb, Sham control
Keywords
CAR-T cell therapy, MUC+, PD-1 Knockout, Non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • CAR-T CellsBiological

    Using the T cells from the patients to produce anti-MUC1 CAR-T Cells and then the cells will be infused back to the patients.

  • CAR-T combining PD-1 KnockoutCombination product

    Using the T cells from the patients to prepare anti-MUC1 CAR-T Cells and PD-1 knockout T cells, then the cells will be infused back to the patients

  • PD-1 knockoutBiological

    Using the T cells from the patients to prepare PD-1 knockout T cells, then the cells will be infused back to the patients

  • PD-1 mAbDrug

    Also called Keytruda

    Patients will be treated with an identical course with a FDA approved monoclonal antibody against PD-1

  • Sham controlOther

    Patient's T cell will treated ex vivo with modification and then infused back in a similar time course.

Study groups in NCT03525782
Study groupRoleWhat they receive
CAR-TExperimentalAnti-MUC1 CAR-T cells will be prepared ex vivo and infused back to the patients.
Receives: Biological: CAR-T Cells
CAR-T combining PD-1 knockoutExperimentalAnti-MUC1 CAR-T cells and PD-1 knockout Engineered T cells will be prepared ex vivo and infused back to the patients.
Receives: Biological: CAR-T Cells; Combination Product: CAR-T combining PD-1 Knockout; Biological: PD-1 knockout
PD-1 knockoutExperimentalPD-1 knockout Engineered T cells will be prepared ex vivo and infused back to the patients.
Receives: Biological: PD-1 knockout
PD-1 mAbActive comparatorPatients will be treated with a FDA approved monoclonal antibody for an identical course of treatment. This group will serve as PD-1 antibody treated group.
Receives: Drug: PD-1 mAb
Sham ControlPlacebo comparatorPatient's T cells will be separate without genetic or engineered modification ex vivo and infused back to the patients.
Receives: Other: Sham control

What is being measured

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

  1. Number of participants with adverse events and dose limiting toxicities as assessed by CTCAE v4.0

    Safety and tolerability of dose of CART-cells and PD-1 Knockout T cells will be assessed using CTCAE v4.0.

    Measured: approximately 6 months

Secondary outcomes (4)

  1. Response Rate

    Will be assessed according to the revised RECIST guideline v1.1

    Measured: 6 months

  2. Overall Survival - OS

    Measure the time from enrollment to death

    Measured: Up to 24 months

  3. Progression free survival - PFS

    Time from enrollment to date of first documented progression or date of death.

    Measured: Up to 12 months

  4. Median CAR-T cell persistence

    Will be measured by quantitative RT-PCR

    Measured: 4 years

Timeline

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

  1. First posted16 May 2018
  2. Study start1 Feb 2018
  3. Primary completion31 Jan 2021 (estimated)
  4. Study completion31 Jan 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
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03525782
Sponsor's protocol ID
2018-006
Status last verified
May 2018
First submitted
26 Apr 2018
Last updated
16 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Barr T, Ma S, Li Z, Yu J. Recent advances and remaining challenges in lung cancer therapy. Chin Med J (Engl). 2024 Mar 5;137(5):533-546. doi: 10.1097/CM9.0000000000002991. Epub 2024 Feb 7.

    PubMed 38321811

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CAR-T Cells, CAR-T combining PD-1 Knockout and PD-1 knockout in people with Lung Neoplasm Malignant and Non-small Cell Lung Cancer, run by The First Affiliated Hospital of Guangdong Pharmaceutical University at 3 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 7 inclusion and 10 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 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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. Some participants in this study may receive a placebo. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events and dose limiting toxicities as assessed by CTCAE v4.0 (time frame: approximately 6 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 NCT03525782, which also lists 1 linked publication.

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 16 May 2018.

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