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Single-center, open, single-arm clinical study on the safety and effectiveness of infusion of autologous NK cells in the treatment of lymphoma

Single-center, open, single-arm clinical study on the safety and effectiveness of infusion of autologous NK cells in the treatment of lymphoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034622
Enrollment
Unknown
Registered
2020-07-12
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-07-13

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

Conditions

Lymphoma

Interventions

1:Test product: NK cells derived from autologous peripheral blood
reinfusion dose: according to patient weight: 2×108/kg
reinfusion route: intravenous infusion/bolus injection for 30 minutes. Reinfusion program: infusion every 3 months, four consecutive infusions

Sponsors

Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients or their legal guardians voluntarily participate and sign the informed consent; 2. Male or female patients aged 18 to 70 years (including 18 and 70 years old); 3. Diagnosed as lymphoma by pathological and histological examination; 4. Subject: After pre-treatment, patients with lymphoma who achieved treatment response (complete remission/partial remission) were evaluated at the final stage. 5. The patient's main tissues and organs function well: 1) Liver function: ALT/AST= 95%; 4) Heart function: Left ventricular ejection fraction (LVEF)>=40%. 6. The patient did not receive any chemotherapy, radiotherapy, immunotherapy (such as immunosuppressive drugs) and other anti-cancer treatments within 4 weeks before enrollment, and his previous treatment-related toxic reactions have recovered to = 3 months.

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant (positive urine/blood pregnancy test) or breastfeeding; 2. Men or women who have a conception plan within the past year; 3. The patient cannot guarantee effective contraception (condom or contraceptive, etc.) within 1 year after enrollment; 4. The patient has an uncontrollable infection within 4 weeks before enrollment; 5. Active hepatitis B/C virus; 6. HIV infected patients; 7. Suffering from severe autoimmune disease or immunodeficiency disease; 8. The patient is allergic and is allergic to antibodies or cytokines and other large molecular biological drugs; 9. The patient participated in other clinical trials within 6 weeks before enrollment; 10. Systemic use of hormones (except for patients using inhaled hormones) within 4 weeks before enrollment; 11. Suffering from mental illness; According to the investigator's judgment, the patient has other situations that are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Adverse events related to NK cell therapy;Serious adverse event;Abnormal laboratory examination with clinical significance;

Secondary

MeasureTime frame
Overall survival;

Countries

China

Contacts

Public ContactWei Sang

Affiliated Hospital of Xuzhou Medical University

sw1981726@126.com+86 13645207648

Outcome results

None listed

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