A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
NCT07915544, Phase 1, Not yet recruiting, Beijing Gene Key Life Technology Co., Ltd
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis | ClinicalTrials.gov |
| NCT number | NCT07915544 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 12 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beijing Gene Key Life Technology Co., Ltd | ClinicalTrials.gov |
| Conditions | Ankylosing Spondylitis | ClinicalTrials.gov |
| Interventions | GKL-006Allo | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 45
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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). | ClinicalTrials.gov |
| Primary | 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). | ClinicalTrials.gov |
| Primary | 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). | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Secondary | Assessment of SpondyloArthritis International Society (ASAS)20 response rate | Weeks 8, 12, 16, 24, 36, and 52 | 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. | ClinicalTrials.gov |
| Secondary | Assessment of SpondyloArthritis International Society (ASAS)40 response rate | Weeks 8, 12, 16, 24, 36, and 52 | 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. | ClinicalTrials.gov |
| Secondary | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 response rate | Weeks 8, 12, 16, 24, 36, and 52 | 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. | ClinicalTrials.gov |
| Secondary | Change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score | Weeks 8, 12, 16, 24, 36, and 52 | BASDAI is scored from 0 (no disease activity) to 10 (worst disease activity), with higher scores indicating worse disease activity. | ClinicalTrials.gov |
| Secondary | Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) score | Weeks 8, 12, 16, 24, 36, and 52 | BASFI is scored from 0 (no functional limitation) to 10 (worst functional limitation), with higher scores indicating worse physical function. | ClinicalTrials.gov |
| Secondary | Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) score | Weeks 8, 12, 16, 24, 36, and 52 | BASMI (linear method) is scored from 0 to 10, with higher scores indicating worse spinal mobility. | ClinicalTrials.gov |
| Secondary | Change from baseline in total back pain score | Weeks 8, 12, 16, 24, 36, and 52 | Total back pain is assessed using a 0-10 numeric rating scale , with higher scores indicating worse back pain. | ClinicalTrials.gov |
| Secondary | Change from baseline in participant's global assessment of disease activity (PGA) | Weeks 8, 12, 16, 24, 36, and 52 | Participant's global assessment of disease activity is assessed using a 0-10 numeric rating scale , with higher scores indicating worse disease activity. | ClinicalTrials.gov |
| Secondary | Change from baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) | Weeks 8, 12, 16, 24, 36, and 52 | MASES evaluates 13 enthesal sites, scored from 0 to 13, with higher scores indicating more severe enthesitis. | ClinicalTrials.gov |
| Secondary | Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) | Weeks 8, 12, 16, 24, 36, and 52 | 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). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)