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An exploratory clinical study of autologous immune cell therapy for pulmonary ground glass nodular disease (GGN)

An exploratory clinical study of autologous immune cell therapy for pulmonary ground glass nodular disease (GGN)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052018
Enrollment
Unknown
Registered
2021-10-13
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary ground glass nodular disease (GGN)

Interventions

Therapy group:Infusion of autologous NK cells (natural killer cells)

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate in clinical trials and sign informed consent; 2. Aged 20-70 years; 3. GGN positive; positivity was defined as having at least one noncalcified solid or partially solid nodule >= 5 mm in diameter, or at least one nonsolid nodule >= 8 mm in diameter; 4. It is not applicable to subjects receiving local treatment (including intervention, radiofrequency ablation, etc.) and other treatments; 5. Routine blood test reached the following indexes: lymphocyte count >= 0.4 x 10^9/L, neutrophil >= 1.0 x 10^9/L, platelet >= 60 x 10^9/L, hemoglobin >= 60g/L; 6. Liver and kidney function: ALT (Alanine Aminotransferase) or AST (Aspartate Aminotransferase) index 50 mL /min; total bilirubin = 50%, no serious arrhythmia; 9. Within 2 months, no anti-inflammatory drugs, immune-enhancing hormones or drugs have been taken or completely recovered from inflammation.

Exclusion criteria

Exclusion criteria: 1. Subjects who have a history of allergy to any component of the study drug; 2. Screening subjects enrolled in another interventional clinical study within 3 weeks prior; 3. Patients who developed other primary malignancies within the past 3 years; 4. Patients who have had an organ transplant or previous cell transplant in the past 20 years; 5. Active infections requiring treatment; 6. Active or previously documented autoimmune or inflammatory diseases; 7. Patients with any form of primary or acquired immune deficiency; 8. Patients with hereditary or acquired coagulation disorders; 9. Central nervous system diseases with clinical significance; 10. The presence of a serious mental illness that prevents full informed consent; 11. Any participant deemed unfit to participate in the study by the investigator.

Design outcomes

Primary

MeasureTime frame
Computed tomography;

Secondary

MeasureTime frame
Immunity indicators;

Countries

China

Contacts

Public ContactShi Hui

Shanghai Tenth People's Hospital

disney1982@163.com+86 1800167481

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026