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Clinical study of TKIs combined with allogeneic amplified activated natural killer cells in the treatment of drug-resistant insensitivity to chronic myeloid leukemia

Clinical study of TKIs combined with allogeneic amplified activated natural killer cells in the treatment of drug-resistant insensitivity to chronic myeloid leukemia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037893
Enrollment
Unknown
Registered
2020-09-04
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-11-09

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

Conditions

Chronic Myeloid Leukemia

Interventions

1:NK infusion

Sponsors

Hematopathy Hospital of Xi'an International Medical Center Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients with Ph + chronic myelocytic leukemia (Ph + CML) with age >= 18 years old (the general condition is good and can be relaxed appropriately); 2. Patients in the chronic phase of CML without history of accelerated or cataclysmic phase; 3. The patients treated with approved TKI were treated for more than 3 months and the daily time was fixed; 4. Patients who did not achieve the main molecular biological response MMR (BCR / ablis >= 1%) or complete hematological response (CHr) were treated regularly by TKI; 5. The patient's economic situation does not allow to continue TKI treatment; 6. The patient or client agrees to participate in the trial and has signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have previously received hematopoietic stem cell transplantation or other immune cell therapy; 2. Patients with malignant tumor other than CML have dysfunction of important organs of heart, brain, liver and kidney; 3. Patients with severe infection or receiving anti tuberculosis treatment; 4. Patients who can not guarantee to complete the necessary treatment plan and follow-up observation; 5. Pregnant and lactating women; 6. Patients who are considered unsuitable for clinical observation by other researchers; 7. Patients who participated in other clinical trials within 4 weeks before the start of this study.

Design outcomes

Primary

MeasureTime frame
BCR-ABL1<0.01;

Secondary

MeasureTime frame
WBC:4~10×109/L;PLT:450×109/L;CD3-CD56+CD16+NK;

Countries

China

Contacts

Public ContactYao Hanbing

Xi'an International Medical Dream Life Science Research Institute

yaohanbing0427@qq.com+86 18092058951

Outcome results

None listed

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