Ankylosing SpondylitisPhase 1NCT07915544
A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
A Phase 1 study testing GKL-006Allo in people with Ankylosing Spondylitis, run by Beijing Gene Key Life Technology Co., Ltd at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- GKL-006Allo
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- Nov 2026to 30 Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Participants must be able to understand the informed consent form and voluntarily agree to participate, with a signed and dated informed consent form.
- Age 18 to 65 years (inclusive), both sexes.
- Diagnosis of ankylosing spondylitis (AS) according to the 1984 modified New York criteria, and classification as axial spondyloarthritis (axSpA) according to the 2025 ASAS-SPARTAN axSpA classification criteria. Participants must have active disease, meeting both of the following criteria: (a) Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4; and (b) spinal pain score >= 4 as measured by BASDAI question 2.
- Prior treatment with at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) at full dose on a regular schedule for at least 4 weeks, with no significant improvement in symptoms as assessed by the investigator; or intolerance to NSAIDs (discontinuation of NSAID treatment due to treatment-related adverse events, such as allergic reactions or gastrointestinal signs or symptoms; the 4-week treatment duration requirement does not apply in this case); or contraindication to NSAID treatment.
- Participants who have received no more than 1 prior biologic agent or JAK inhibitor (agents with the same generic name count as 1): treatment must have been administered at the recommended dose for at least 12 weeks with inadequate response, intolerance (adverse events leading to discontinuation), or inability to continue for other reasons. Washout periods before the first dose: etanercept, 4 weeks; infliximab, 8 weeks; adalimumab, certolizumab pegol, or golimumab, 10 weeks; IL-17 inhibitors, 12 weeks; JAK inhibitors, 4 weeks; biologic classes not listed, 5 drug half-lives.
- If participants are receiving methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine (HCQ), the treatment duration before enrollment must be at least 3 months, and the dose must have been stable for at least 4 weeks.
- Participants of childbearing potential must use at least 1 medically accepted contraceptive method during the study treatment period and for 6 months after the end of study treatment. Serum human chorionic gonadotropin (HCG) must be negative within 7 days before the first dose for women of childbearing potential; participants must be non-lactating and non-pregnant.
- Able to communicate well with the investigator and comply with the requirements of the study.
Who cannot join
- Allergy to immunotherapy or to the excipients of the investigational drug.
- Known or suspected history of complete spinal ankylosis, or complete spinal ankylosis confirmed clinically and radiographically.
- Complete ankylosis of the sacroiliac joints.
- Spinal or joint surgery within 2 months before dosing, or planned spinal or joint surgery during the study period.
- Other untreated malignancy within the past 5 years or concomitant malignancy, except adequately treated skin basal cell carcinoma, carcinoma in situ, and breast cancer with no recurrence for more than 3 years after curative surgery.
- Any active, known, or suspected autoimmune disease other than the indication under study (including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, vasculitis, glomerulonephritis, uveitis, hypophysitis, and hyperthyroidism). Exceptions: type 1 diabetes mellitus on stable-dose insulin therapy for at least 3 months before enrollment; hypothyroidism requiring only hormone replacement therapy; and skin conditions (such as eczema, vitiligo, or psoriasis) requiring no systemic treatment and without acute exacerbation within 1 year before screening.
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- Severe trauma or major surgery (such as transabdominal or transthoracic surgery) within 6 months before screening, or planned major surgery during the study.
- History of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis (may be enrolled if only detected on imaging and no corticosteroid treatment is required), or drug-induced pneumonitis.
- Poorly controlled cardiac signs, symptoms, or diseases: (a) congestive heart failure of NYHA class II or above; Poorly controlled cardiac signs, symptoms, or diseases: (a) heart failure of New York Heart Association (NYHA) class II or above;b) unstable angina within 6 months; (c) acute myocardial infarction within 1 year; (d) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (such as QTc > 450 msec in males or > 470 msec in females).
- Hypertension not well controlled by antihypertensive medication (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg within 7 days before enrollment).
- Cerebrovascular or cardiovascular events within 3 months before dosing (myocardial infarction, ischemic or hemorrhagic stroke excluding lacunar infarction, deep vein thrombosis, etc.).
- Any of the following at screening or baseline: (a) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x ULN; (b) serum creatinine > 1.5 x ULN or glomerular filtration rate < 60 mL/min/1.73 m2; (c) activated partial thromboplastin time (APTT) > 1.5 x ULN or prothrombin time (PT) > 2.5 x ULN (without anticoagulant therapy); (d) left ventricular ejection fraction <= 50%; (e) urine protein > 2+ on urinalysis within 7 days before enrollment, confirmed by 24-hour urine protein quantification > 1.0 g; (f) white blood cell count < 3 x 10^9/L, hemoglobin < 90 g/L, absolute neutrophil count < 1.5 x 10^9/L, or platelet count < 90 x 10^9/L.
- Any of the following bleeding conditions: bleeding events of CTCAE v6.0 grade 2 or above within 4 weeks before enrollment; gastrointestinal bleeding history or definite gastrointestinal bleeding within 6 months before enrollment, or bleeding from esophageal and/or gastric varices without endoscopic or transjugular intrahepatic portosystemic shunt prophylaxis; known hereditary or acquired bleeding or thrombotic tendency (such as hemophilia or coagulation disorders).
- Systemic active infection requiring treatment within 2 weeks before enrollment, or unexplained fever with temperature >= 38.5 degrees C within 7 days before enrollment.
- Congenital or acquired immunodeficiency (such as HIV infection); active syphilis infection; positive tuberculosis test.
- HBV or HCV infection at screening with viral load above the lower limit of detection (HBV DNA >= 10 IU/mL or HCV RNA >= 10 IU/mL).
- Prior receipt of genetically modified cell therapy, or receipt of non-genetically modified cell therapy within 6 months before screening.
- Prior use of oral glucocorticoids, or receipt of glucocorticoids by any intra-articular, intramuscular, or intravenous injection.
- Receipt of disease-modifying antirheumatic drugs (DMARDs) other than sulfasalazine and hydroxychloroquine within 1 month before dosing; leflunomide discontinued for less than 8 weeks; or discontinuation for less than 5 drug half-lives according to the actual drug class (i.e., the DMARD washout period should exceed 5 half-lives of the corresponding drug), whichever is longer.
- Current use of strong opioid analgesics (such as methadone, hydromorphone, or morphine).
- Vaccination with live or attenuated vaccines within 4 weeks before screening.
- Enrollment in another clinical study of a drug or device within 4 weeks before screening.
- Other factors judged by the investigator that may lead to premature study termination, such as other serious concomitant diseases (including severe diabetes, thyroid disease, spinal cord compression, superior vena cava syndrome, or psychiatric illness), severe laboratory abnormalities, or family or social factors that may affect participant safety or the collection of data and samples.
- Intolerance to venipuncture, or history of needle or blood phobia.
- History of alcoholism, drug abuse, or use of any illicit drugs.
- Other factors considered by the investigator to be unsuitable for enrollment or likely to affect participant participation or completion of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
First Medical Center of Chinese PLA General Hospital
Beijing
Jian Zhu, MD, +86-10-55499314, Jian_jzhu@126.com
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
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.
- Conditions
- Ankylosing Spondylitis
- Being tested
- GKL-006Allo
- Keywords
- GKL-006Allo, iNKT, invariant natural killer T cells, allogeneic cell therapy
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GKL-006AlloBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| GKL-006Allo Injection | Experimental | 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. Receives: Biological: GKL-006Allo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline through end of study (approximately 52 weeks after first dose)
Secondary outcomes (35)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 8, 12, 16, 24, 36, and 52
Changes from baseline in erythrocyte sedimentation rate (ESR)
Change from baseline in ESR.
Measured: Weeks 8, 12, 16, 24, 36, and 52
Changes from baseline in C-reactive protein (CRP)
Change from baseline in CRP .
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weeks 12, 24, and 52
Peak concentration (Cmax) of invariant natural killer T (iNKT) cells in peripheral blood
Measured: Weeks 0 to 20
Time to peak concentration (Tmax) of iNKT cells in peripheral blood
Measured: 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
Measured: Weeks 0 to 20
Area under the concentration-time curve from time zero to infinity (AUC0-inf) of iNKT cells in peripheral blood
Measured: Weeks 0 to 20
Half-life (t1/2) of iNKT cells in peripheral blood
Measured: Weeks 0 to 20
Last detectable concentration (Clast) of iNKT cells in peripheral blood
Measured: Weeks 0 to 20
Time of last measurable concentration (tlast) of iNKT cells in peripheral blood
Measured: Weeks 0 to 20
Change from baseline in NK cells (CD3- CD56+)
Measured: Weeks 0 to 20 and Weeks 24 and 52
Change from baseline in activated NK cells (CD3- CD56+ CD69+)
Measured: Weeks 0 to 20 and Weeks 24 and 52
Change from baseline in T cells (CD8+)
Measured: Weeks 0 to 20 and Weeks 24 and 52
Change from baseline in myeloid-derived suppressor cells (MDSCs, CD11b+ CD33+)
Measured: Weeks 0 to 20 and Weeks 24 and 52
Change from baseline in plasma interferon-gamma (IFN-gamma) concentration
Measured: Weeks 0 to 20 and Weeks 24 and 52
Change from baseline in plasma tumor necrosis factor-alpha (TNF-alpha) concentration
Measured: Weeks 0 to 20 and Weeks 24 and 52
Change from baseline in plasma interleukin-6 (IL-6) concentration
Measured: Weeks 0 to 20 and Weeks 24 and 52
Change from baseline in plasma interleukin-17A (IL-17A) concentration
Measured: 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).
Measured: Weeks 0, 4, and 12; and at Weeks 24 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startNov 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Gene Key Life Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915544
- Sponsor's protocol ID
- GKL006AlloAID01
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT07915544
- Acronym / sponsor ID
- GKL006AlloAID01
- Conditions
- Ankylosing Spondylitis
- Keywords
- GKL-006Allo, iNKT, invariant natural killer T cells, allogeneic cell therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Beijing Gene Key Life Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 4 Nov 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GKL-006Allo Injection | Experimental | Biological: GKL-006AlloParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must be able to understand the informed consent form and voluntarily agree to participate, with a signed and dated informed consent form.
- Age 18 to 65 years (inclusive), both sexes.
- Diagnosis of ankylosing spondylitis (AS) according to the 1984 modified New York criteria, and classification as axial spondyloarthritis (axSpA) according to the 2025 ASAS-SPARTAN axSpA classification criteria. Participants must have active disease, meeting both of the following criteria: (a) Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4; and (b) spinal pain score >= 4 as measured by BASDAI question 2.
- Prior treatment with at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) at full dose on a regular schedule for at least 4 weeks, with no significant improvement in symptoms as assessed by the investigator; or intolerance to NSAIDs (discontinuation of NSAID treatment due to treatment-related adverse events, such as allergic reactions or gastrointestinal signs or symptoms; the 4-week treatment duration requirement does not apply in this case); or contraindication to NSAID treatment.
- Participants who have received no more than 1 prior biologic agent or JAK inhibitor (agents with the same generic name count as 1): treatment must have been administered at the recommended dose for at least 12 weeks with inadequate response, intolerance (adverse events leading to discontinuation), or inability to continue for other reasons. Washout periods before the first dose: etanercept, 4 weeks; infliximab, 8 weeks; adalimumab, certolizumab pegol, or golimumab, 10 weeks; IL-17 inhibitors, 12 weeks; JAK inhibitors, 4 weeks; biologic classes not listed, 5 drug half-lives.
Key exclusion criteria (26 listed)
- Allergy to immunotherapy or to the excipients of the investigational drug.
- Known or suspected history of complete spinal ankylosis, or complete spinal ankylosis confirmed clinically and radiographically.
- Complete ankylosis of the sacroiliac joints.
- Spinal or joint surgery within 2 months before dosing, or planned spinal or joint surgery during the study period.
- Other untreated malignancy within the past 5 years or concomitant malignancy, except adequately treated skin basal cell carcinoma, carcinoma in situ, and breast cancer with no recurrence for more than 3 years after curative surgery.
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 |
|---|---|---|
| GKL-006AlloAllogeneic 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. | Biological | GKL-006Allo Injection |
Primary outcome
Dose-limiting toxicities (DLTs) of GKL-006Allo injection
Time frame: 28 days after the first dose of GKL-006Allo
Number and percentage of participants experiencing DLTs at each dose level during the DLT observation window, assessed per protocol-defined criteria.
Frequency of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From first dose through end of study (approximately 52 weeks after first dose)
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.
Change from baseline in systolic blood pressure
Time frame: Baseline through end of study (approximately 52 weeks after first dose)
Vital signs will be measured at each scheduled visit. Descriptive statistics will be provided for observed values and changes from baseline.Units: mmHg.
Change from baseline in diastolic blood pressure
Time frame: Baseline through end of study (approximately 52 weeks after first dose)
Vital signs will be measured at each scheduled visit. Descriptive statistics will be provided for observed values and changes from baseline.Units: mmHg.
Change from baseline in pulse rate
Time frame: Baseline through end of study (approximately 52 weeks after first dose)
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).
Change from baseline in respiratory rate
Time frame: Baseline through end of study (approximately 52 weeks after first dose)
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).
Change from baseline in body temperature
Time frame: Baseline through end of study (approximately 52 weeks after first dose)
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).
Number of participants with clinically significant changes from baseline in physical examination findings
Time frame: Baseline through end of study (approximately 52 weeks after first dose)
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.
Number of participants with clinically significant shifts from baseline in laboratory test results
Time frame: Baseline through end of study (approximately 52 weeks after first dose)
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.
Number of participants with abnormal 12-lead electrocardiogram (ECG) findings
Time frame: Baseline through end of study (approximately 52 weeks after first dose)
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.
35 secondary outcomes
Assessment of SpondyloArthritis International Society (ASAS)20 response rate
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Assessment of SpondyloArthritis International Society (ASAS)40 response rate
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 response rate
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) score
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) score
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in total back pain score
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in participant's global assessment of disease activity (PGA)
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in Assessment of SpondyloArthritis international Society Health Index (ASAS HI) score
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in 44-joint swollen joint count
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in dactylitis count
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Changes from baseline in erythrocyte sedimentation rate (ESR)
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Changes from baseline in C-reactive protein (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)
Time frame: Weeks 8, 12, 16, 24, 36, and 52
Change from baseline in Hospital Anxiety and Depression Scale (HADS) score
Time frame: Weeks 12, 24, and 52
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score
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
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
Time frame: Weeks 0, 4, and 12; and at Weeks 24 and 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- 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.
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 GKL-006Allo in people with Ankylosing Spondylitis, run by Beijing Gene Key Life Technology Co., Ltd 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 26 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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhu, MD (+86-10-55499314, Jian_jzhu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (DLTs) of GKL-006Allo injection (time frame: 28 days after the first dose of GKL-006Allo). The study lists 10 primary outcomes in all. 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 4 Nov 2026.