NeuroblastomaNCT01802138
A Pilot Study of Activated T Cell Therapy for Refractory/Relapsed Neuroblastoma
A study testing Activated T lymphocyte in people with Neuroblastoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Activated T cell were manufactured through in vitro T cell expansion of autologous T cell. We designed this study to determine the feasibility and safety of Activated T-lymphocyte cell therapy for refractory/relapsed neuroblastoma patients. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Neuroblastoma
- What is being tested?
- Activated T lymphocyte
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to 31 Oct 2018
- Phase
- Interventional
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Informed consent
- Age 21 years or younger
- Histologically confirmed neuroblastoma
- Progressive disease after standard treatment or relapsed patient
- ECOG scale (ECOG-PS) ≤2
- Expected survival at least 3 months
Who cannot join
- Patients with autoimmune disease
- Patients with immunodeficiency
- Other malignancy 5 year prior to this study
- Severe organ dysfunction
- Severe allergic disease
- Severe psychiatric disorder
- Pregnancy or lactating woman
Trial locations and contacts
1 site in 1 country.
About this study
Activated T cell were manufactured through in vitro T cell expansion of autologous T cell. We designed this study to determine the feasibility and safety of Activated T-lymphocyte cell therapy for refractory/relapsed neuroblastoma patients.
- Conditions
- Neuroblastoma
- Being tested
- Activated T lymphocyte
- Keywords
- refractory/relapsed neuroblastoma patients
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated T lymphocyteBiological
Also called Immuncell-LC
intravenous dripping of 200 ml (10^9~2*10^10 lymphocytes) for 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Activated T-lymphocyte | Experimental | This was designed as a single-center, single group clinical trial, and subjects include patients with refractory refractory/relapsed neuroblastoma.
If subjects agree to participate in the clinical trial by signing a written consent, only appropriate subjects, who meet the criteria on the examinations and tests, will undergo this clinical trial. To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 3 weeks before administration. Subjects should visit to hospital according to the protocol and receive a study drug. Therapeutic response rate, overall survival rate, time to progression should be investigated. Receives: Biological: Activated T lymphocyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
T cell count after in vitro expansion
T cell count after in vitro expansion
Evaluation of safety
Measured: up to 13 weeks
Secondary outcomes (1)
Number of participants who showed response with Response Evaluation Criteria in Solid Tumors criteria
To determine the response rate
To evaluate 1 yr progression free survival and overall survival
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.
- First posted1 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2016
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroblastomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01802138
- Sponsor's protocol ID
- ILC_IIT_03
- Status last verified
- Apr 2019
- First submitted
- 21 Feb 2013
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Activated T Cell Therapy for Refractory/Relapsed Neuroblastoma
- ClinicalTrials.gov ID
- NCT01802138
- Acronym / sponsor ID
- ILC_IIT_03
- Conditions
- Neuroblastoma
- Keywords
- refractory/relapsed neuroblastoma patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2016 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 1 Mar 2013 (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.
Activated T cell were manufactured through in vitro T cell expansion of autologous T cell. We designed this study to determine the feasibility and safety of Activated T-lymphocyte cell therapy for refractory/relapsed neuroblastoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Activated T-lymphocyte | Experimental | Biological: Activated T lymphocyteThis was designed as a single-center, single group clinical trial, and subjects include patients with refractory refractory/relapsed neuroblastoma. If subjects agree to participate in the clinical trial by signing a written consent, only appropriate subjects, who meet the criteria on the examinations and tests, will undergo this clinical trial. To participate in the clinical trial, subject's blood of more than 60 ml should be withdrawn to make a study drug at least 3 weeks before administration. Subjects should visit to hospital according to the protocol and receive a study drug. Therapeutic response rate, overall survival rate, time to progression should be investigated. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Informed consent
- Age 21 years or younger
- Histologically confirmed neuroblastoma
- Progressive disease after standard treatment or relapsed patient
- ECOG scale (ECOG-PS) ≤2
Key exclusion criteria (7 listed)
- Patients with autoimmune disease
- Patients with immunodeficiency
- Other malignancy 5 year prior to this study
- Severe organ dysfunction
- Severe allergic 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 |
|---|---|---|
| Activated T lymphocyteAlso: Immuncell-LCintravenous dripping of 200 ml (10^9~2*10^10 lymphocytes) for 1 hour. | Biological | Activated T-lymphocyte |
Primary outcome
T cell count after in vitro expansion
Time frame: up to 13 weeks
T cell count after in vitro expansion Evaluation of safety
1 secondary outcome
Number of participants who showed response with Response Evaluation Criteria in Solid Tumors criteria
Time frame: up to 1 year
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 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activated T lymphocyte in people with Neuroblastoma, run by Seoul National University Hospital at 1 site in South Korea.
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 6 inclusion and 7 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 Apr 2019. 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 South Korea. 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.
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?
T cell count after in vitro expansion (time frame: up to 13 weeks). 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 Apr 2019.