Clinical trial · Interventional
Donor-derived Anti-CD123-CART Cells for Recurred AML After Allo-HSCT
Donor-derived Anti-CD123 Chimeric Antigen Receptors Modified T Cells for Recurred Acute Myeloid Leukaemia After Allogeneic Hematopoietic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with acute myeloid leukemia(AML) recurred after the allogeneic hematopoietic stem cell transplantation (allo-HSCT) have a dismal prognosis.The investigators developed donor-derived chimeric antigen receptor modified-T cell(CART) to target CD123 for the treatment of AML. The investigators start the Phase I study aimed to treat recurred post-transplantation AML patients using donor-derived CAR-T. The purpose of this study is to assess the safety and effectiveness of anti-CD123 CAR-T cells in patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Myeloid Leukemia | Adult Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD123CAR-41BB-CD3zeta-EGFRt-expressing T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CD123CAR-41BB-CD3zeta-EGFRt-expressing T cells
- description
- Patients will receive a full dose CART infusion at day 0.
- interventionNames
- Biological: CD123CAR-41BB-CD3zeta-EGFRt-expressing T cells
Primary outcomes (1)
- measure
- Incidence of adverse events related to treatment as assessed by NCI CTCAE version 4.03
- timeFrame
- 15 years
Secondary outcomes (4)
- measure
- CART cells persistence in vivo
- timeFrame
- 15 years
- measure
- CAR123-specific antibody level
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male and Female subjects with CD123+ acute myeloid leukemia as confirmed by immunohistochemistry and flow cytometry; 2. Patients must have received an allogenic stem cell transplantation(Allo-HSCT). The leukemia relapsed. There are available donor or enough cryopreserved donor-derived PBMCs for CART preparation and subsequent Allo-HSCT. In the previous case, the donor should have adequate venous access for apheresis. 3. Karnofsky score greater than 70%; 4. patients more than 18 years of age 5. Expected survival time \>16 weeks; 6. Bilirubin \<3.0 mg/dL, 7. Alanine aminotransferase(ALT)/ aspartate aminotransferase(AST)\<3 fold normal. 8. Diffusing capacity of the lung for carbon monoxide(DLCO) and forced expiratory volume in one second(FEV1)\>45% of predictive value. 9. At least received three kinds of medicines functioning by different mechanisms, including alkylating agents, protease inhibitors, and immunomodulators, and disease progressing within 60 days. 10. Important organs are well tolerated; 11. For post-transplantation patients, the apheresis would be undertaken only at least 2 weeks after immunosuppressive agents for GvHD withdrawal; 12. From very beginning of the test to 30 days after the withdrawal, men and women should adopt reliable contraceptive measures. 13. All research participants must have the ability to understand and willingness to sign a written informed consent. Exclusion criteria: 1. Patients were diagnosed with APL M3:t(15; 17)(q22; q12);PML/RARα ); 2. Symptomatic active central nervous system leukaemia; 3. Patients with HIV, hepatitis B or C infection; 4. Any concurrent active malignancies; 5. Other uncontrolled active illness that hinders participation in the trial; 6. Patients suffer from coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage and other serious heart, cerebrovascular disease; 7. patients with poorly controlled hypertensive 8. patients with froward psychiatric history 9. anyone who the researchers think unsuitable to participate in the investigation; 10. anyone who long-term use of immunosuppressive agents for organ transplants or other reasons, or undertake inhaled corticosteroids therapy recently. 11. failed production release testing: CAR+ T cells \<30% or T cell expansion less than 5-fold under the CD3/28 beads stimulation. 12. Pregnant, lactating or female patients planning to get pregnant within 2 months before treatment ends;
References
Publications (0)
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