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Sequential Infusion of CD19 and BCMA CAR-T Cells to Improve PTR in Patients With AL

NCT04846439 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-10-27

No results posted yet for this study

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.

Conditions

  • Platelet Transfusion Refractoriness
  • Acute Leukemia in Remission

Interventions

BIOLOGICAL

CAR-T infusion

Sequential infusion of CD19 and BCMA autologous chimeric antigen receptor T cells, the infusion dose was determined according to the body weight of the subject and the effective content of cell preparation.

Sponsors & Collaborators

  • The Second People's Hospital of Huai'an

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    collaborator OTHER

  • Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

    collaborator INDUSTRY

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • Haiping Dai, Ph.D · The First Affiliated Hospital of Soochow University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-29
Primary Completion
2023-03-31
Completion
2024-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04846439 on ClinicalTrials.gov