A Phase 1 interventional study of GKL-006Allo in Ankylosing Spondylitis, sponsored by Beijing Gene Key Life Technology Co., Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Beijing Gene Key Life Technology Co., Ltd · Phase 1, Interventional, and Treatment
Ankylosing spondylitis (AS) is a long-term inflammatory disease that mainly affects the spine and sacroiliac joints, causing back pain and stiffness. Some patients do not respond well to existing treatments. This study will test an investigational cell therapy called GKL-006Allo injection, made from donor-derived invariant natural killer T (iNKT) cells and given by intravenous infusion.
The study will evaluate two dose levels of GKL-006Allo, given once every two weeks for up to 11 doses. The study starts at a lower dose. After a safety review committee confirms the safety of the current dose level, the study may move to a higher dose. The main purposes are to find out how safe and well tolerated GKL-006Allo is, how it moves through the body (pharmacokinetics), whether it triggers an immune response (immunogenicity), and to collect early information on whether it improves AS.
Researchers will monitor participants for 52 weeks after the first dose to track safety and disease-related measures.
531 studies on the registry are indexed under Spondylitis, Ankylosing; 98 are open to participants now.
This study's planned enrollment of 12 is below the median of 88 across 302 interventional studies indexed under Spondylitis, Ankylosing.
Browse Spondylitis, Ankylosing studies →Beijing Gene Key Life Technology Co., Ltd is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive GKL-006Allo injection by intravenous infusion once every two weeks for up to 11 doses. Participants are assigned to one of two dose levels, a low dose of (3.0±0.9)×10\^8 cells/m2 or a high dose of (9.0±2.7)×10\^8 cells/m2, with the low-dose level enrolled first and the high-dose level opened after safety review per the dose-escalation rules.
Biological: GKL-006Allo
Allogeneic invariant natural killer T (iNKT) cells administered by intravenous infusion once every two weeks for up to 11 doses. Dose escalation from (3.0±0.9)×10\^8 cells/m2 to (9.0±2.7)×10\^8 cells/m2 per the 3+3 dose-escalation design.
Dose-limiting toxicities (DLTs) of GKL-006Allo injection
Number and percentage of participants experiencing DLTs at each dose level during the DLT observation window, assessed per protocol-defined criteria.
Time frame: 28 days after the first dose of GKL-006Allo
Frequency of adverse events (AEs) and serious adverse events (SAEs)
Number and percentage of participants with AEs and SAEs, including treatment-emergent events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Time frame: From first dose through end of study (approximately 52 weeks after first dose)
Change from baseline in systolic blood pressure
Vital signs will be measured at each scheduled visit. Descriptive statistics will be provided for observed values and changes from baseline.Units: mmHg.
Time frame: Baseline through end of study (approximately 52 weeks after first dose)
Change from baseline in diastolic blood pressure
Vital signs will be measured at each scheduled visit. Descriptive statistics will be provided for observed values and changes from baseline.Units: mmHg.
Time frame: Baseline through end of study (approximately 52 weeks after first dose)
Change from baseline in pulse rate
Vital signs will be measured at each scheduled visit. Descriptive statistics will be provided for observed values and changes from baseline.Units: beats per minute (bpm).
Time frame: Baseline through end of study (approximately 52 weeks after first dose)
Change from baseline in respiratory rate
Vital signs will be measured at each scheduled visit. Descriptive statistics will be provided for observed values and changes from baseline.Units: beats per minute (bpm).
Time frame: Baseline through end of study (approximately 52 weeks after first dose)
Change from baseline in body temperature
Vital signs will be measured at each scheduled visit. Descriptive statistics will be provided for observed values and changes from baseline.Units:degrees Celsius (°C).
Time frame: Baseline through end of study (approximately 52 weeks after first dose)
Number of participants with clinically significant changes from baseline in physical examination findings
Physical examinations will be performed at each scheduled visit. Post-dose findings will be graded by the most severe clinical significance assessment recorded after dosing. The number of participants with abnormal findings at baseline without clinical significance that became abnormal with clinical significance after dosing will be summarized.
Time frame: Baseline through end of study (approximately 52 weeks after first dose)
Number of participants with clinically significant shifts from baseline in laboratory test results
Laboratory tests include hematology, serum chemistry, coagulation, urinalysis, and thyroid function tests. Cross-tabulations of baseline and post-baseline results (by clinical significance) will be provided. The number of participants shifting from normal at baseline to abnormal after dosing, and from abnormal without clinical significance at baseline to abnormal with clinical significance after dosing, will be summarized by test category.
Time frame: Baseline through end of study (approximately 52 weeks after first dose)
Number of participants with abnormal 12-lead electrocardiogram (ECG) findings
12-lead ECGs (including heart rate, rhythm, and RR, PR, QRS, and QTc intervals) will be recorded at each scheduled visit and assessed for clinical significance. Participants with normal baseline ECG becoming abnormal after dosing, and participants with abnormal baseline ECG without clinical significance becoming abnormal with clinical significance after dosing, will be counted.
Time frame: Baseline through end of study (approximately 52 weeks after first dose)
Assessment of SpondyloArthritis International Society (ASAS)20 response rate
Proportion of participants achieving an ASAS20 response. ASAS20 response is defined as at least 20% improvement from baseline in at least 3 of the 4 ASAS domains (patient global assessment of disease activity, pain, function \[BASFI\], and inflammation \[morning stiffness\]), with no worsening (deterioration of ≥20%) in any of the remaining domains.
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Assessment of SpondyloArthritis International Society (ASAS)40 response rate
Proportion of participants achieving an ASAS40 response, defined as at least 40% improvement from baseline in at least 3 of the 4 ASAS domains, with no worsening in the remaining domain, assessed in the same manner as ASAS20.
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 response rate
Proportion of participants achieving a BASDAI50 response. BASDAI is scored from 0 (no disease activity) to 10 (worst disease activity), with higher scores indicating worse disease activity. BASDAI50 response is defined as at least 50 percent improvement from baseline in BASDAI.
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score
BASDAI is scored from 0 (no disease activity) to 10 (worst disease activity), with higher scores indicating worse disease activity.
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) score
BASFI is scored from 0 (no functional limitation) to 10 (worst functional limitation), with higher scores indicating worse physical function.
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) score
BASMI (linear method) is scored from 0 to 10, with higher scores indicating worse spinal mobility.
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in total back pain score
Total back pain is assessed using a 0-10 numeric rating scale , with higher scores indicating worse back pain.
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in participant's global assessment of disease activity (PGA)
Participant's global assessment of disease activity is assessed using a 0-10 numeric rating scale , with higher scores indicating worse disease activity.
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
MASES evaluates 13 enthesal sites, scored from 0 to 13, with higher scores indicating more severe enthesitis.
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
Change from baseline in Ankylosing Spondylitis Disease Activity Score using C-reactive protein (ASDAS-CRP).ASDAS-CRP is calculated from 5 parameters: total back pain (BASDAI question 2, numeric rating scale \[NRS\]), participant's global assessment of disease activity, peripheral joint pain/swelling (BASDAI question 3, NRS), duration of morning stiffness (BASDAI question 6, NRS), and serum C-reactive protein (CRP, mg/L). ASDAS-CRP = 0.121 x back pain + 0.058 x duration of morning stiffness + 0.110 x participant global assessment + 0.073 x peripheral joint pain/swelling + 0.579 x Ln(CRP + 1).
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in Assessment of SpondyloArthritis international Society Health Index (ASAS HI) score
ASAS HI is scored from 0 to 17, with higher scores indicating worse health status.
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in 44-joint swollen joint count
Swollen joints are assessed in 44 joints, with higher counts indicating more active synovitis.
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in dactylitis count
Dactylitis is assessed as the number of digits with dactylitis, with higher counts indicating more severe dactylitis.
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Changes from baseline in erythrocyte sedimentation rate (ESR)
Change from baseline in ESR.
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Changes from baseline in C-reactive protein (CRP)
Change from baseline in CRP .
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Proportion of participants achieving ankylosing spondylitis disease activity score using C-reactive protein (ASDAS-CRP) low disease activity (ASDAS < 2.1) and clinical remission (ASDAS < 1.3)
Proportion of participants achieving Ankylosing Spondylitis Disease Activity Score using C-reactive protein (ASDAS-CRP) low disease activity (ASDAS \< 2.1) and clinical remission (ASDAS \< 1.3). ASDAS-CRP is calculated from participant's global assessment, total back pain, peripheral joint pain/swelling, duration of morning stiffness, and serum C-reactive protein (CRP, mg/L), per the published ASDAS-CRP formula. Higher scores indicate worse disease activity. Disease activity is categorized as: clinical remission, ASDAS \< 1.3; low disease activity, ASDAS 1.3 to \< 2.1; high disease activity, ASDAS 2.1 to 3.5; very high disease activity, ASDAS \> 3.5.
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in Hospital Anxiety and Depression Scale (HADS) score
HADS comprises anxiety and depression subscales, each scored from 0 to 21 (total score 0-42), with higher scores indicating worse anxiety and depression.
Time frame: Weeks 12, 24, and 52
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score
PSQI global score ranges from 0 to 21, with higher scores indicating worse sleep quality.
Time frame: Weeks 12, 24, and 52
Changes from baseline in sacroiliac joint inflammation on MRI assessed by the Spondyloarthritis Research Consortium of Canada (SPARCC) score
Sacroiliac joint MRI is performed at scheduled visits. Sacroiliac joint inflammation is quantified using the Spondyloarthritis Research Consortium of Canada (SPARCC) sacroiliac joint score (range 0-36, bilateral), with higher scores indicating more severe inflammation.
Time frame: Weeks 12, 24, and 52
Peak concentration (Cmax) of invariant natural killer T (iNKT) cells in peripheral blood
Time frame: Weeks 0 to 20
Time to peak concentration (Tmax) of iNKT cells in peripheral blood
Time frame: Weeks 0 to 20
Area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t) of iNKT cells in peripheral blood
Time frame: Weeks 0 to 20
Area under the concentration-time curve from time zero to infinity (AUC0-inf) of iNKT cells in peripheral blood
Time frame: Weeks 0 to 20
Half-life (t1/2) of iNKT cells in peripheral blood
Time frame: Weeks 0 to 20
Last detectable concentration (Clast) of iNKT cells in peripheral blood
Time frame: Weeks 0 to 20
Time of last measurable concentration (tlast) of iNKT cells in peripheral blood
Time frame: Weeks 0 to 20
Change from baseline in NK cells (CD3- CD56+)
Time frame: Weeks 0 to 20 and Weeks 24 and 52
Change from baseline in activated NK cells (CD3- CD56+ CD69+)
Time frame: Weeks 0 to 20 and Weeks 24 and 52
Change from baseline in T cells (CD8+)
Time frame: Weeks 0 to 20 and Weeks 24 and 52
Change from baseline in myeloid-derived suppressor cells (MDSCs, CD11b+ CD33+)
Time frame: Weeks 0 to 20 and Weeks 24 and 52
Change from baseline in plasma interferon-gamma (IFN-gamma) concentration
Time frame: Weeks 0 to 20 and Weeks 24 and 52
Change from baseline in plasma tumor necrosis factor-alpha (TNF-alpha) concentration
Time frame: Weeks 0 to 20 and Weeks 24 and 52
Change from baseline in plasma interleukin-6 (IL-6) concentration
Time frame: Weeks 0 to 20 and Weeks 24 and 52
Change from baseline in plasma interleukin-17A (IL-17A) concentration
Time frame: Weeks 0 to 20 and Weeks 24 and 52
Incidence of anti-drug antibodies (ADA) against invariant natural killer T (iNKT) cell surface antigens
Number and percentage of participants with anti-drug antibodies (ADA) against iNKT cell surface antigens (mainly human leukocyte antigen (HLA) class I/II molecules).
Time frame: Weeks 0, 4, and 12; and at Weeks 24 and 52
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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