Sequential Infusion of CD19 and BCMA CAR-T Cells to Improve PTR in Patients With AL (NCT04846439) | Clinical Trial Compass
UnknownPhase 1/2
Sequential Infusion of CD19 and BCMA CAR-T Cells to Improve PTR in Patients With AL
China20 participantsStarted 2021-04-29
Plain-language 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 need repeated platelet infusion in myelosuppression period after chemotherapy, and PTR incidence is more higher.PTR was associated with adverse events,including longer hospital stays,severe hemorrhages and an increased risk of early deaths and may have a negative impact on the success of HSCT. The current management of patients with PTR includes specific transfusion strategies, IVIG, rituximab,thrombopoietin-receptor agonists(TPO-RA) ,bortezomib or splenectomy,have been largely unsatisfactory. As we know, HLA antibodies are mainly secreted by the plasma cells. Researchers want to see if sequential infusion of CD19 and BCMA CAR-T cells can clear the B cells and plasma cells, can help increase platelet levels and reduce bleeding in patients with platelet transfusion refractoriness. To see if sequential infusion can increases platelet levels more after a transfusion. To see if it reduces the chance of bleeding. Adults 16-65 years old who diagnosed with acute leukemia in CR and alloimmune platelet transfusion refractoriness.
Who can participate
Age range
16 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Subjects With Sustained Platelet Transfusion Responsiveness
Timeframe: 12 months
2
Adverse events after sequential infusion of CAR-T
Timeframe: 12 months
Trial details
NCT IDNCT04846439
SponsorThe First Affiliated Hospital of Soochow University