Relapsed or Refractory CD123+ Acute Myeloid Leukemia and BPDCN
Conditions
Interventions
single arm: CAR -T treatment
Sponsors
Beijing Shijitan Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
2 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 24 months, = 0.01% in bone marrow after allogeneic HCT or with extramedullary relapse after allogeneic HCT transplantation. Patients with refractory and relapsed AML who could not be cured by traditional treatment and could not receive HSCT for various reasons. In peripheral blood, bone marrow, spleen, lymph nodes, skin, and / or other local histology and / or cytology, bpdcn includes bpdcn that has not been treated before or is persistent / recurrent after treatment; 3. The life expectancy was more than 3 months; 4. Organ function evaluation: kidney: normal serum creatinine or creatinine 28%, EF > 50%. At room temperature, the saturation of blood oxygen is more than or equal to 90%. At the time of selection, ECoG is less than or equal to 2 points; 5. Within 3 months before enrollment, HIV antibody, Treponema pallidum antibody and hepatitis C antibody were all negative, and HBV DNA copy number was less than 100 IU / ml; 6. Be able to tolerate the collection of monocytes through venous pathway; 7. Women of childbearing age must be determined not to be pregnant by pregnancy test, and effective contraceptive measures shall be taken within 12 months after the end of the test; all male subjects shall take contraceptive measures during the test period and within 3 months after the last administration; 8. Understand and sign the informed consent form and volunteer for clinical trial. Children over 10 years old shall sign the informed consent form together with their parents or legal guardians, and children under 10 years old shall sign the informed consent form by their parents or legal guardians; 9. Subjects were able to comply with the study visit schedule and other protocol requirements, including follow-up to the survival assessment.
Exclusion criteria
Exclusion criteria: 1. After allogeneic hematopoietic stem cell transplantation, or have received other allogeneic organ transplantation or xenotransplantation; 2. Active bacteria, viruses, fungi, mycobacteria and parasites were known to infect other infections (excluding fungal infection of nail bed) or any major systemic infection event requiring intravenous antibiotic treatment or hospitalization (excluding treatment of tumor fever) within 4 weeks before enrollment; 3. Suspected active or latent tuberculosis patients; 4. Severe heart, lung, liver and kidney dysfunction, or other organ dysfunction, unexplained history of syncope; active autoimmune disease; 5. Allergic constitution, or known to be allergic to the active ingredients, excipients or mouse derived products or heterogeneous proteins of any drug included in this test; 6. Pregnant and lactating women; 7. The subjects had a history of alcoholism or drug abuse, severe mental illness; 8. Is receiving or has received any gene therapy products; 9. Those who used any monoclonal antibody or participated in other clinical trials within 3 months before admission and judged that the treatment was effective (excluding those who had not been relieved or the tumor had relapsed after the above treatment). 10. Those who had been vaccinated (attenuated) live virus vaccine within one month before admission; 11. It is difficult for peripheral blood monocytes to expand T cells to meet the need of treatment; 12. Subjects who used prednisone > 5mg / day or equivalent corticosteroids within 2 weeks before cell collection; 13. Primary central nervous system disease or tumor infiltration (excluding central nervoussystem metastasis of leukemia); 14. Patients suffering from other malignant tumors or major diseases at the same time; 15. Subjects unable to comply during the trial and / or follow-up phase; 16. Those who had received radiotherapy within 3 months before admission; 17. Those who had received other anti-tumor therapy (such as targeted drug therapy, traditional Chinese medicine treatment, cell therapy or immunotherapy) in the first month before entering the group and were judged to be effective (excluding those who had not been relieved or had relapsed after the above treatment); 18. Other researchers don't think it's suitable for the participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events ;overall response Summary ;overall survival rate ;Median Survival Time ;event free survival; | — |
Countries
China
Contacts
Public ContactZhong Xiaosong
Beijing Shijitan Hospital Affiliated to Capital Medical University
Outcome results
None listed