Recurrent PD-L1+ Malignant TumorsPhase 1NCT02930967
Chimeric Switch Receptor Modified T Cells for Patients With PD-L1+ Recurrent or Metastatic Malignant Tumors
A Phase 1 study testing autologous CSR T in people with Recurrent PD-L1+ Malignant Tumors and Metastatic PD-L1+ Malignant Tumors, run by China Meitan General Hospital at 1 site in China.
Trial summary
A Chimeric Switch Receptor, which was constructed by fusing the PD1 extracellular ligand binding domain to the CD28 intracellular costimulatory domain, was designed to target PD-L 1 positive tumors . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Recurrent PD-L1+ Malignant Tumors, Metastatic PD-L1+ Malignant Tumors
- What is being tested?
- autologous CSR T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Aug 2019
- Phase
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with PD-L1 positive, recurrent or metastatic malignant tumors , including but not limited to pancreatic cancer, renal cancer, colorectal cancer, lymphoma, breast cancer and lung cancer;
- measurable tumors by RECIST1.1 standard;
- patients are 18 to 70 years old;
- life expectancy > 3months;
- KPS ≥70;
- satisfactory major organ functions: adequate heart function with LVEF≥50%; no obvious abnormities in ECG; pulse oximetry ≥ 90%; cockcroft-gault creatinine clearance≥40 ml/min; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3ULN; Bilirubin ≤2.0 mg/dl ;
- Blood: Hgb ≥ 80 g/L, ANC ≥ 1×10^9/L, PLT ≥ 50×10^9/L;
- women of reproductive potential must have a negative pregnancy test. Male and female of reproductive potential must agree to use birth control during the study and one year post study.
Who cannot join
- patients with a prior history of autoimmune disease or other diseases who need long-term use of systemic hormone drug or immunosuppressive therapy
- active infection.
- HIV positive.
- active hepatitis B virus infection or hepatitis C virus infection.
- currently enrolled in other study.
- patients, in the opinion of investigators, may not be eligible or are not able to comply with the study.
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- patients with allergic disease, or are allergic to T cell products or other biological agents used in the study.
- patients whose tumors have metastasized to bone, or have clinical signs of bone metastasis, such as bone and joint pain.
- patients with brain metastasis, or have clinical signs of brain metastasis, such as loss of self-consciousness.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China Meitan General Hospital
Beijing, 100028
Shidong Wei, MD, +86-13146634751, liqinghe9644679@163.com
About this study
Official title: A Safety and Efficacy Study of Chimeric Switch Receptor Modified T Cells in Patients With Recurrent or Metastatic Malignant Tumors
A Chimeric Switch Receptor, which was constructed by fusing the PD1 extracellular ligand binding domain to the CD28 intracellular costimulatory domain, was designed to target PD-L 1 positive tumors . In this single-arm, open-label, one center, dose escalation clinical study, the main purpose is to determine the safety and efficacy of infusion of autologous Chimeric Switch Receptor modified T cells (CSR T) in adult patients with PD-L1 positive, recurrent or metastatic malignant tumors.
- Being tested
- autologous CSR T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous CSR TBiological
Patients will be received a three-day regimen of chemotherapy consisting of cyclophosphamide aimed to deplete the lymphocytes. 1 to 4 days after lymphodepletion, a prescribed dose of CSR T cells will be intravenously infused to patient in a three-day split-dose regimen (day0,10%; day1, 30%; day2, 60%).
| Study group | Role | What they receive |
|---|---|---|
| CSR T cells | Experimental | A dose escalation clinical study aimed to assess the safety and efficacy of CSR T cells in patients with PD-L1 positive tumors.
CSR T dosage ranging from: 5×10^4 /kg to 1×10^7 /kg will be tested. Receives: Biological: autologous CSR T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by incidents of treatment related adverse events as assessed by CTCAE V4.0.
safety of infusion of autologous CSR T cells with cyclophosphamide as lymphodepleting chemotherapy
Measured: 2 years
Secondary outcomes (5)
treatment response rate of CSR T cell infusion
defined as the proportion of patients who achieved complete remission (CR), partial remission (PR), stable disease (SD), or progressive disease (PD).
Measured: 4 weeks
overall survival rate
Measured: 2 years
progression-free survival
Measured: 6 months
proliferation of CSR T cells in patients
Measured: 2 years
Persistence of CSR T cells in patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent PD-L1+ Malignant TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Meitan General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Marino Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, Jinwen Sun, China Meitan General Hospital
- Investigators
- Jinwen Sun, MD, Principal investigator, China Meitan General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930967
- Sponsor's protocol ID
- K16-3
- Status last verified
- Oct 2016
- First submitted
- 10 Oct 2016
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of Chimeric Switch Receptor Modified T Cells in Patients With Recurrent or Metastatic Malignant Tumors
- ClinicalTrials.gov ID
- NCT02930967
- Acronym / sponsor ID
- K16-3
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- China Meitan General HospitalUniversity, hospital or other
- Collaborators
- Marino Biotechnology Co., Ltd.
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 12 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Chimeric Switch Receptor, which was constructed by fusing the PD1 extracellular ligand binding domain to the CD28 intracellular costimulatory domain, was designed to target PD-L 1 positive tumors . In this single-arm, open-label, one center, dose escalation clinical study, the main purpose is to determine the safety and efficacy of infusion of autologous Chimeric Switch Receptor modified T cells (CSR T) in adult patients with PD-L1 positive, recurrent or metastatic malignant tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CSR T cells | Experimental | Biological: autologous CSR TA dose escalation clinical study aimed to assess the safety and efficacy of CSR T cells in patients with PD-L1 positive tumors. CSR T dosage ranging from: 5×10^4 /kg to 1×10^7 /kg will be tested. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with PD-L1 positive, recurrent or metastatic malignant tumors , including but not limited to pancreatic cancer, renal cancer, colorectal cancer, lymphoma, breast cancer and lung cancer;
- measurable tumors by RECIST1.1 standard;
- patients are 18 to 70 years old;
- life expectancy > 3months;
- KPS ≥70;
Key exclusion criteria (9 listed)
- patients with a prior history of autoimmune disease or other diseases who need long-term use of systemic hormone drug or immunosuppressive therapy
- active infection.
- HIV positive.
- active hepatitis B virus infection or hepatitis C virus infection.
- currently enrolled in other study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous CSR TPatients will be received a three-day regimen of chemotherapy consisting of cyclophosphamide aimed to deplete the lymphocytes. 1 to 4 days after lymphodepletion, a prescribed dose of CSR T cells will be intravenously infused to patient in a three-day split-dose regimen (day0,10%; day1, 30%; day2, 60%). | Biological | CSR T cells |
Primary outcome
Safety as assessed by incidents of treatment related adverse events as assessed by CTCAE V4.0.
Time frame: 2 years
safety of infusion of autologous CSR T cells with cyclophosphamide as lymphodepleting chemotherapy
5 secondary outcomes
treatment response rate of CSR T cell infusion
Time frame: 4 weeks
overall survival rate
Time frame: 2 years
progression-free survival
Time frame: 6 months
proliferation of CSR T cells in patients
Time frame: 2 years
Persistence of CSR T cells in patients
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jinwen Sun, MD principal investigator
China Meitan General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing autologous CSR T in people with Recurrent PD-L1+ Malignant Tumors and Metastatic PD-L1+ Malignant Tumors, run by China Meitan General 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 8 inclusion and 9 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 12 Oct 2016. 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?
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.
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 Shidong Wei, MD (+86-13146634751, liqinghe9644679@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as assessed by incidents of treatment related adverse events as assessed by CTCAE V4.0. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Oct 2016.