Status:
UNKNOWN
Sequential Infusion of CD19 and BCMA CAR-T Cells to Improve PTR in Patients With AL
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Collaborating Sponsors:
The Second People's Hospital of Huai'an
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Platelet Transfusion Refractoriness
Acute Leukemia in Remission
Eligibility:
All Genders
16-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Alloimmune-mediated platelet transfusion refractoriness(PTR) was usually caused by repeated blood transfusions and pregnancy and accounts for about 20-25% of PTR patients. Patients with acute leukemia...
Detailed Description
The patients will receive infusion of CAR T-cells targeting CD19 and BCMA to confirm the safety and efficacy of CD19 and BCMA CAR T-Cells Sequential infusion in acute leukemia with alloimmune-mediated...
Eligibility Criteria
Inclusion
- Ages 16-65 years inclusive.
- Ability to comprehend the investigational nature of the study and provide informed consent.
- Expected survival time ≥ 3 months (according to investigator's judgement)
- Acute leukemia in complete remission diagnosed with alloimmune-mediated PTR, characterized by all of the following:
- Lack of adequate post-transfusion platelet count increment, defined by CCI \<7500/μl at 10-60 min, and CCI \<5000/μl at 18-24 hrs (in those who had a CCI at 10-60 min greater than or equal to 5000/μl) after at least 2 consecutive transfusions.
- Presence of anti-HLA class A and/or B antibody.
- Left ventricular ejection fractions ≥ 0.5 by echocardiography.
- Creatinine \< 1.6 mg/dL.
- Aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal.
- Total bilirubin \<2.0 mg/dL.
- karnofsky performance status ≥ 60.
Exclusion
- PTR induced by other reasons(eg:DIC,fever,infection and splenomegaly)
- Uncontrolled active infection.
- Active hepatitis B or hepatitis C infection
- Patients with HIV or syphilis infection
- Patients are pregnant or lactating
- Patients has a history of allo-HSCT
- Alloimmune-mediated PTR responsive to treatment with plasma exchange
- Alloimmune-mediated PTR responsive to treatment with rituximab or IVIG
- Grade III/IV cardiovascular disability according to the New York Heart Association Classification
- Patients with other contraindications considered unsuitable for participation in this study (according to investigator's judgement)
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04846439
Start Date
April 29 2021
End Date
March 31 2024
Last Update
October 27 2021
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006