NCT04846439

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

Status unknown Phase 1, PHASE2 Last updated 27 October 2021

What this trial tests

Phase 1, PHASE2 trial testing CAR-T infusion in Platelet Transfusion Refractoriness in 20 participants. Status unknown.

Timeline

29 April 2021

Primary endpoint
31 March 2023

31 March 2024

Quick facts

Lead sponsor	The First Affiliated Hospital of Soochow University
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	29 April 2021
Primary completion	31 March 2023
Estimated completion	31 March 2024
Sites	1 location across China

Drugs / interventions tested

• CAR-T infusion — full drug profile →

Conditions studied

• Platelet Transfusion Refractoriness — all drugs for Platelet Transfusion Refractoriness →
• Acute Leukemia in Remission — all drugs for Acute Leukemia in Remission →

Sponsor

The First Affiliated Hospital of Soochow University

Who can join

Adults 16 to 65, any sex, with Platelet Transfusion Refractoriness or Acute Leukemia in Remission. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A deep insight into CRISPR/Cas9 application in CAR-T cell-based tumor immunotherapies.
   Razeghian E, Nasution MKM, Rahman HS, Gardanova ZR, et al · · 2021 · cited 80× · PMID 34321099 · DOI 10.1186/s13287-021-02510-7
2. CRISPR, CAR-T, and NK: Current applications and future perspectives.
   Khoshandam M, Soltaninejad H, Hamidieh AA, Hosseinkhani S. · · 2024 · cited 11× · PMID 38545126 · DOI 10.1016/j.gendis.2023.101121