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Study on the role of dual CD33-CD123-CAR-T cells in the treatment of relapsed/refractory acute myeoloid leukemia

Role of dual CD33-CD123-CAR-T cells in the treatment of relapsed/refractory acute myeoloid leukemia: a single center, phase I study

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018669
Enrollment
Unknown
Registered
2018-10-02
Start date
2018-10-01
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

Relapsed/refractory acute myeoloid leukemia

Interventions

Case series:No

Sponsors

Department of Hematology, Xinqiao Hospital, Army Medical University, Chongqing, People's Republic of China.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. To be able to understand and voluntarily sign an informed consent form; 2. Male or Female aged at least 18 years; 3. Patients with CD33 and/or CD123 positive refractory/relapsed AML according to FAB; 4. The estimated survival is over three months; 5. With detectable disease; 6. Unwilling or unable to receive hematopoietic stem cell transplantation or relapse after transplantation;. 7. Adequate main organ function: (1) Liver: ALT/AST 40 %. 8. Karnofsky =60 at study entry.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding female subject. 2. Drug abusers or 3. uncontrolled infection 4 weeks before enrolled. 4. Known positive for HIV or acute infectious hepatitis, type A, B or C 5. other primary tumor except for AML. 6. Serious autoimmune disease or mmune deficiency disorder. 7. Central nervous involvement 8. Serious psychiatric or psychological disorders. 9. Patients can not be enrolled which will be judged by the researchers.

Design outcomes

Primary

MeasureTime frame
Rate of remission;

Secondary

MeasureTime frame
Addvert effect;

Countries

China

Contacts

Public ContactZhang Xi

Department of Hematology, Xinqiao Hospital, Army Medical University

zhangxxi@sina.com+86 023-68755609

Outcome results

None listed

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