PsoriasisPhase 1/2NCT01894373
Autologous Cytokine Induced Killer Cells (CIK) for Patients With Severe Psoriasis
A Phase 1/2 study testing Adoptive Immunotherapy and CIK in people with Psoriasis and Adoptive Immunotherapy, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
to determine the therapeutic roles of CIK cells on patients with psoriasis Read more about this study
- Who is it for?
- Ages 12 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis, Adoptive Immunotherapy
- What is being tested?
- Adoptive Immunotherapy and CIK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Jun 2017
- 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 12 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Have ever had a physician's diagnosis of chronic moderate to severe plaque psoriasis and be a candidate for treatment with CIK Are being treated with or initiating CIK therapy at the time of enrollment Be able to provide written informed consent Be willing and able to fully to participate for the duration of patient follow-up (5 years)
Who cannot join
- PUVA or Grenz ray therapy within 4 weeks prior to randomisation. UVB therapy within 2 weeks prior to randomisation. Systemic treatment with biological therapies (marketed or otherwise) with a possible effect on psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 3 months prior to randomisation.
- Systemic treatment other than biologicals with a possible effect on psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, hydroxycarbamide, azathioprine, meth-otrexate, cyclosporine, other immunosuppressants) within 4 weeks prior to randomisation.
- Any topical treatment of the scalp (except for medicated shampoos and emollients) within 2 weeks prior to randomisation (medicated shampoos/emollients are not allowed during the double-blind phase). Shampoos containing corticosteroids, e.g. Clobex®, are not allowed within 2 weeks prior to randomisation.
- Planned use of topical treatment for psoriasis of the trunk or limbs, besides study medication, during the study with the exceptions of: • emollient • medications used to treat psoriasis of the skin folds and/or genitals (any medication may be used for this purpose apart from Class 1-5 corticosteroids.
- Topical treatment of the face with Class 1-5 corticosteroids within 2 weeks prior to randomisation.
- Planned initiation of, or changes to, concomitant medication that could affect psoriasis (e.g., beta blockers, anti-malaria drugs, lithium) during the double-blind phase of the study.
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- Treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to randomisation.
- Planned use of chemical treatments of the hair (eg relaxers, 'perms', or colourings) during the double-blind phase of the study.
- Current diagnosis of erythrodermic, exfoliative or pustular psoriasis. Patients with any of the following conditions also present on psoriatic areas of the scalp or trunk/limbs: viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis or syphilis, rosacea, acne rosacea, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers or wounds.
- Other inflammatory skin diseases that may confound the evaluation of psoriasis of the scalp or trunk/limbs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autologous Cytokine Induced Killer Cells as Adjuvant Adoptive Immunotherapy in Patients With Psoriasis
to determine the therapeutic roles of CIK cells on patients with psoriasis
- Conditions
- Psoriasis, Adoptive Immunotherapy
- Being tested
- Adoptive Immunotherapy, CIK
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adoptive ImmunotherapyDrug
Biological: in vitro expanded Cytokine Induced Killer (CIK) cells Procedure: Infusion of autologous CIK cells
CIKBiological
| Study group | Role | What they receive |
|---|---|---|
| CIK, psoriasis | Experimental | Not described Receives: Drug: Adoptive Immunotherapy; Biological: CIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
therapeutic roles of CIK on psoriasis
changes of area and extent of skin lesions
Measured: 1 year
Secondary outcomes (1)
Occurrence of study related adverse events
adverse effect after CIK cell infusion
Measured: within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startJun 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
- Investigators
- Han weidong, doctor, Study director, Institute of immunology，Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894373
- Sponsor's protocol ID
- HWD301
- Status last verified
- Jun 2015
- First submitted
- 27 Jun 2013
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dai H, Zhou Y, Tong C, Guo Y, Shi F, Wang Y, Shen P. Restoration of CD3+CD56+ cell level improves skin lesions in severe psoriasis: A pilot clinical study of adoptive immunotherapy for patients with psoriasis using autologous cytokine-induced killer cells. Cytotherapy. 2018 Sep;20(9):1155-1163. doi: 10.1016/j.jcyt.2018.07.003. Epub 2018 Aug 9.
PubMed 30100374
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Cytokine Induced Killer Cells as Adjuvant Adoptive Immunotherapy in Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT01894373
- Acronym / sponsor ID
- HWD301
- Conditions
- Psoriasis, Adoptive Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 10 Jul 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.
to determine the therapeutic roles of CIK cells on patients with psoriasis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CIK, psoriasis | Experimental | Drug: Adoptive Immunotherapy, Biological: CIK |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Have ever had a physician's diagnosis of chronic moderate to severe plaque psoriasis and be a candidate for treatment with CIK Are being treated with or initiating CIK therapy at the time of enrollment Be able to provide written informed consent Be willing and able to fully to participate for the duration of patient follow-up (5 years)
Key exclusion criteria (10 listed)
- PUVA or Grenz ray therapy within 4 weeks prior to randomisation. UVB therapy within 2 weeks prior to randomisation. Systemic treatment with biological therapies (marketed or otherwise) with a possible effect on psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 3 months prior to randomisation.
- Systemic treatment other than biologicals with a possible effect on psoriasis (e.g., corticosteroids, vitamin D analogues, retinoids, hydroxycarbamide, azathioprine, meth-otrexate, cyclosporine, other immunosuppressants) within 4 weeks prior to randomisation.
- Any topical treatment of the scalp (except for medicated shampoos and emollients) within 2 weeks prior to randomisation (medicated shampoos/emollients are not allowed during the double-blind phase). Shampoos containing corticosteroids, e.g. Clobex®, are not allowed within 2 weeks prior to randomisation.
- Planned use of topical treatment for psoriasis of the trunk or limbs, besides study medication, during the study with the exceptions of: • emollient • medications used to treat psoriasis of the skin folds and/or genitals (any medication may be used for this purpose apart from Class 1-5 corticosteroids.
- Topical treatment of the face with Class 1-5 corticosteroids within 2 weeks prior to randomisation.
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 |
|---|---|---|
| Adoptive ImmunotherapyBiological: in vitro expanded Cytokine Induced Killer (CIK) cells Procedure: Infusion of autologous CIK cells | Drug | CIK, psoriasis |
| CIK | Biological | CIK, psoriasis |
Primary outcome
therapeutic roles of CIK on psoriasis
Time frame: 1 year
changes of area and extent of skin lesions
1 secondary outcome
Occurrence of study related adverse events
Time frame: within 2 weeks
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 17 May 2018.
- Derived from this study: PubMed 30100374Dai H, Zhou Y, Tong C, Guo Y, Shi F, Wang Y, Shen P. Restoration of CD3+CD56+ cell level improves skin lesions in severe psoriasis: A pilot clinical study of adoptive immunotherapy for patients with psoriasis using autologous cytokine-induced killer cells. Cytotherapy. 2018 Sep;20(9):1155-1163. doi: 10.1016/j.jcyt.2018.07.003. Epub 2018 Aug 9.
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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.
Han weidong, doctor study director
Institute of immunology，Chinese PLA 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 1/2 study testing Adoptive Immunotherapy and CIK in people with Psoriasis and Adoptive Immunotherapy, run by Chinese PLA 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 1 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: finished, as of the sponsor's last update on 17 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 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?
therapeutic roles of CIK on psoriasis (time frame: 1 year). 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 NCT01894373, 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 17 May 2018.