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Exploratory study of targeted activation of CIK cells in the treatment of MRD positive acute myeloid leukemia

Exploratory study of targeted activation of CIK cells in the treatment of MRD positive acute myeloid leukemia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059812
Enrollment
Unknown
Registered
2022-05-12
Start date
2022-05-05
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

MRD positive acute myeloid leukemia

Interventions

Experimental group:Targeted activation of CIK cells

Sponsors

Beijing GoBroad Boren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Tumor surface antigen CD33 was expressed at diagnosis in patients with acute myeloid leukemia with persistent positive gene residue or after allogeneic hematopoietic stem cell transplantation; 2. Male or female patients, aged 18-70; 3. No severe allergic constitution; 4. 0-2 points for the physical condition; 5. Estimated survival >=60 days; 6. At the initial onset, bone marrow or cerebrospinal fluid tumor cells were CD33 positive by flow cytometry or tumor tissue was CD33 positive by immunohistochemistry (CD33 positive: flow cytometry: >80% of tumor cells expressed CD33 and tumor MFI was not lower than that of the normal myeloid system; More than 80% of tumor cells expressed CD33, but MFI was lower than normal myeloid cells and CD33 expression was dim by 1log. CD33 was partially expressed in 20-80% of tumor cells. Histopathological immunohistochemistry: positive tumor cells greater than >30% were considered positive); 7. Disagree with chemotherapy and salvage bone marrow transplant patients; 8. MRD positive subjects who do not meet the conditions of allogeneic transplantation; 9. Patients with self-awareness ability need to sign the informed consent in person with a voluntary letter.

Exclusion criteria

Exclusion criteria: 1. Intracranial hypertension or brain disturbance; 2. Symptomatic heart failure or severe arrhythmia; 3. symptoms of severe respiratory failure; 4. With other types of malignant tumors; 5. Diffuse intravascular coagulation; 6. Serum creatinine and/or urea nitrogen >= 1.5 times the normal value; 7. suffering from sepsis or other uncontrollable infections; 8. Suffering from uncontrolled diabetes; 9. Severe mental disorders; 10. Brain MRI examination showed obvious intracranial lesions; 11. Have received an organ transplant (excluding bone marrow transplant); 12. Positive blood HCG test in female patients (fertile patients); 13. Screening for positive hepatitis (including hepatitis B and C), AIDS and syphilis.

Design outcomes

Primary

MeasureTime frame
Total survival time;

Secondary

MeasureTime frame
Progression-free survival time;Objective response rate;Duration of remission;

Countries

China

Contacts

Public ContactDefeng Zhao

Beijing GoBroad Boren Hospital

zhaodf@gobroadhealthcare.com+86 18601903811

Outcome results

None listed

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