A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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. 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.
Eligibility
Primary outcome measure(s)
- Dose-limiting toxicities (DLTs) of GKL-006Allo injection — 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) — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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 — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| First Medical Center of Chinese PLA General Hospital | Beijing | China |
More Beijing Gene Key Life Technology Co., Ltd trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07915544 on ClinicalTrials.gov ↗ ← All trials in China