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Clinical study of autologous CIK cells in the therapy of solid tumors

Clinical study of autologous CIK cells in the treatment of solid tumors

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047639
Enrollment
Unknown
Registered
2021-06-21
Start date
2021-07-15
Completion date
Unknown
Last updated
2022-02-28

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

Conditions

Solid tumor

Interventions

The treatment group:CIK cell therapy

Sponsors

Gansu Wuwei Tumor Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-80 years old (including 18 and 80 years old); 2. Patients diagnosed as an advanced malignant solid tumor with definite pathological and CT imaging evidence; Consolidation and maintenance after completion of standard treatment regimens (radiotherapy, chemotherapy, hormone therapy, surgery); Or failure of existing standard regiments (radiotherapy, chemotherapy, hormone therapy, surgery); 3. Karnofsky performance >= 60%, expected survival time >= 6 months; Patients who can cooperate to observe adverse reactions and efficacy; 4. Normal function of major organs, that is, meeting the following criteria: Blood routine: HB >= 90g/L (no blood transfusion or EPO dependence within 14 days); ANC > = 1.5 * 10 ^ 9 / L; PLT > = 100 x 10 ^ 9 / L; Blood biochemistry: TBIL = 60ml/min; Urine routine examination urine protein less than 2+; Good coagulation function, INR and PT <= 1.5 times ULN; If subject is receiving anticoagulant therapy, as long as PT is within the prescribed range of anticoagulant drugs, it is acceptable; 5. Patients shall give informed consent to this study before the test and voluntarily sign a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Highly allergic or have a history of severe allergy, especially to IL-2; 2. With shock, general failure, abnormal vital signs, and inability to cooperate with the examination; 3. With mental or psychological diseases who cannot cooperate with treatment and efficacy evaluation; 4. T lymphocyte carcinoma/tumor (not suitable for CIK cell therapy); 5. Patients with systemic infection or severe local infection need anti-infection treatment; 6. Cardiac function grade ?, hypertension grade ?, renal insufficiency (creatinine clearance rate < 30mL/min), or tumor patients with multiple organ failure; 7. Coagulation disorders (such as hemophilia); 8. Patients who cannot undergo lymphocyte separation or a small amount of multiple blood drawing: for example, patients with coronary heart disease and peripheral venous channels cannot be opened; 9. In order to prevent cross-infection in the laboratory, all patients admitted to our hospital should have the negative test certificate of AIDS and syphilis, and should not receive somatic immunotherapy for patients with hepatitis B, AIDS, syphilis, and active tuberculosis. 10. Women who are pregnant or breast-feeding, or who plan to have a pregnancy within six months; 11. Patients who are on immunosuppressive drugs or long-term use of immunosuppressants after organ transplantation, or who have used large amounts of glucocorticoids or other immunosuppressants within 4 weeks; 12. Tumor patients with severe autoimmune diseases; 13. Patients with intractable or persistent epilepsy; 14. Any condition that the Investigator considers likely to increase the risk to the subject or to interfere with the results of the study.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Overall survival;Objective response rate;Disease control rate;

Countries

China

Contacts

Public ContactYe Yancheng

Gansu Wuwei Tumor Hospital

zlyyyyc@163.com+86 13993536626

Outcome results

None listed

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