Malignant Solid TumorPhase 1/2NCT03551795
Clinical Research on Comprehensive Treatment of Tuberculosis With Malignant Solid Tumor
A Phase 1/2 study testing Infusion of iNKT cells in people with Malignant Solid Tumor, run by Xiaoyan Zhang at 1 site in China.
Trial summary
Invariant Natural killer T (iNKT) cells are a unique subset of lymphocytes that express homogeneous TCR recognizing KRN7000 which was up-regulated by many kinds of cancer cells.The hypothesis of the investigators is that immunotherapy strategy of infusion of iNKT cells may resist inflection and decrease the tumor… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Malignant Solid Tumor
- What is being tested?
- Infusion of iNKT cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Mar 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytologically diagnosis of tuberculosis with malignant solid tumor
- Patients' tumor tissue (formalin-fixed, paraffin-embedded) must be sufficient for diagnosis of cancer by a certified Laboratory of Pathology
- Laboratory values within the following ranges prior to receiving treatment of study agent: Hemoglobin≧8.0 g/dL, Neutrophils count≧1E9/L, Lymphocytes count≧lower limit of institutional normal, Platelet count≧50E9/L, Serum creatinine≦2.0 mg/dL, Serum bilirubin≦2 x upper limit of institutional normal, AST/ALT≦2 x upper limit of institutional normal
- No dyspnea at rest. Oxygen saturation ≥90% on room air
- No genetic disease
- Fertile females/males must consent to use contraceptives during participation of the trial. Women of child bearing potential must have a negative pregnancy test prior to receiving treatment of study agent within 7 days
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- Patients must have a Karnofsky performance status greater than or equal to 80%
- Able and willing to give witnessed, written informed consent form prior to receiving any study related procedure
- Agrees to participate in long-term follow-up for up to 1 years, if received NKT infusion
Who cannot join
- Organ dysfunction,such as significant cardiovascular disease, myocardial infarction within the past six months, unstable angina, coronary angioplasty within the past six months, uncontrolled atrial or ventricular cardiac arrhythmias; Child-Pugh C; Renal function failure or uremia; Respiratory failure; Disturbance of consciousness; Renal failure.
- Suffering from lymphoma or leukemia
- Serious infections requiring antibiotics, bleeding disorders
- Patients with myelodysplastic syndrome (MDS)
- History of immunodeficiency disease or autoimmune disease
- Positive HIV antigen and antibody, Hepatitis B surface antigen and Hepatitis C PCR within 21 days prior to enrollment
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- Within concurrent chemotherapy
- Concurrent other medical condition that would prevent the patient from undergoing protocol-based therapy
- Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent
- Pregnant or breast-feeding patients
- Can't give informed consent
- Lack of availability for follow-up assessment
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Public Health Clinical Center, Fudan University
Shanghai, 201508
About this study
Invariant Natural killer T (iNKT) cells are a unique subset of lymphocytes that express homogeneous TCR recognizing KRN7000 which was up-regulated by many kinds of cancer cells.The hypothesis of the investigators is that immunotherapy strategy of infusion of iNKT cells may resist inflection and decrease the tumor burden and improve overall survival. The purpose of this study is to assess the safety and efficacy of treatment of tuberculosis with malignant solid tumor by infusing of iNKT cells.
Read the detailed description
Treatment of tuberculosis with malignant solid tumor is great unsolved challenge to the physicians. Efficacy of conventional treatment, such as surgery, radiotherapy and chemotherapy is limited. AS novel therapy, immunotherapy shows great prospects.
Human iNKT cells can directly lysis tumor cells by a perforin-dependent mechanism,and intracellular granzyme B expression may also potentiate cell killing. Tumor cells expressing CD1d may be especially susceptible to direct NKT cell lysis. iNKT cells play important role in immune regulation by secreting various cytokines. Expansion method of iNKT cells in vitro is developed as published in the patent of the investigators. Infusion of iNKT cells has been proved safe in mice.
In this clinical trial, the safety and efficacy of the immunotherapy of infusion of iNKT cells are assessed.
- Conditions
- Malignant Solid Tumor
- Being tested
- Infusion of iNKT cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion of iNKT cellsBiological
The eligible patients receive twice infusions of iNKT cells(1E8~1E10) in one course of treatment.
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | The eligible patient receive the experimental infusion of iNKT cells. Receives: Biological: Infusion of iNKT cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Change of target focus confirmed by CT or MRI
Measured: up to 4 months post-infection
Secondary outcomes (1)
Incidence of adverse events related to the infusion of cells
The incidence of adverse events following infusion of iNKT cells
Measured: 28 days post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start1 Jan 2018
- Primary completion30 Dec 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaoyan Zhang
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Xiaoyan Zhang, Shanghai Public Health Clinical Center
- Investigators
- Qing J Xu, Ph.D, Study chair, Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jin Shan, Shanghai 201508, P.R. China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551795
- Sponsor's protocol ID
- iNKT20180427V1.1
- Status last verified
- May 2022
- First submitted
- 1 May 2018
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on Comprehensive Treatment of Tuberculosis With Malignant Solid Tumor
- ClinicalTrials.gov ID
- NCT03551795
- Acronym / sponsor ID
- iNKT20180427V1.1
- Conditions
- Malignant Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Xiaoyan ZhangOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 11 Jun 2018 (actual)
- 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.
Invariant Natural killer T (iNKT) cells are a unique subset of lymphocytes that express homogeneous TCR recognizing KRN7000 which was up-regulated by many kinds of cancer cells.The hypothesis of the investigators is that immunotherapy strategy of infusion of iNKT cells may resist inflection and decrease the tumor burden and improve overall survival. The purpose of this study is to assess the safety and efficacy of treatment of tuberculosis with malignant solid tumor by infusing of iNKT cells.
Detailed description
Treatment of tuberculosis with malignant solid tumor is great unsolved challenge to the physicians. Efficacy of conventional treatment, such as surgery, radiotherapy and chemotherapy is limited. AS novel therapy, immunotherapy shows great prospects.
Human iNKT cells can directly lysis tumor cells by a perforin-dependent mechanism,and intracellular granzyme B expression may also potentiate cell killing. Tumor cells expressing CD1d may be especially susceptible to direct NKT cell lysis. iNKT cells play important role in immune regulation by secreting various cytokines. Expansion method of iNKT cells in vitro is developed as published in the patent of the investigators. Infusion of iNKT cells has been proved safe in mice.
In this clinical trial, the safety and efficacy of the immunotherapy of infusion of iNKT cells are assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Biological: Infusion of iNKT cellsThe eligible patient receive the experimental infusion of iNKT cells. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histological or cytologically diagnosis of tuberculosis with malignant solid tumor
- Patients' tumor tissue (formalin-fixed, paraffin-embedded) must be sufficient for diagnosis of cancer by a certified Laboratory of Pathology
- Laboratory values within the following ranges prior to receiving treatment of study agent: Hemoglobin≧8.0 g/dL, Neutrophils count≧1E9/L, Lymphocytes count≧lower limit of institutional normal, Platelet count≧50E9/L, Serum creatinine≦2.0 mg/dL, Serum bilirubin≦2 x upper limit of institutional normal, AST/ALT≦2 x upper limit of institutional normal
- No dyspnea at rest. Oxygen saturation ≥90% on room air
- No genetic disease
Key exclusion criteria (12 listed)
- Organ dysfunction,such as significant cardiovascular disease, myocardial infarction within the past six months, unstable angina, coronary angioplasty within the past six months, uncontrolled atrial or ventricular cardiac arrhythmias; Child-Pugh C; Renal function failure or uremia; Respiratory failure; Disturbance of consciousness; Renal failure.
- Suffering from lymphoma or leukemia
- Serious infections requiring antibiotics, bleeding disorders
- Patients with myelodysplastic syndrome (MDS)
- History of immunodeficiency disease or autoimmune disease
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 |
|---|---|---|
| Infusion of iNKT cellsThe eligible patients receive twice infusions of iNKT cells(1E8~1E10) in one course of treatment. | Biological | treatment |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 4 months post-infection
Change of target focus confirmed by CT or MRI
1 secondary outcome
Incidence of adverse events related to the infusion of cells
Time frame: 28 days post-infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: No
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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.
Qing J Xu, Ph.D study chair
Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jin Shan, Shanghai 201508, P.R. China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Infusion of iNKT cells in people with Malignant Solid Tumor, run by Xiaoyan Zhang 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 9 inclusion and 12 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: finished, as of the sponsor's last update on 9 May 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to 4 months post-infection). 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 9 May 2022.