NCT05705570View on ClinicalTrials.gov

Clinical Trial Using CAR- T Cells for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies

PHASE1RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 7, 2023

Primary Completion Date

May 1, 2028

Study Completion Date

December 1, 2028

Conditions
Acute Lymphoblastic Leukemia, in RelapseAcute Lymphoblastic Leukemia RefractoryB-cell Lymphoma RecurrentB-cell Lymphoma RefractoryChronic Lymphocytic Leukemia RecurrentChronic Lymphocytic Leukemia Refractory
Interventions
DRUG

Cyclophosphamide

Cyclophosphamide 60mg/Kg on day -6

DRUG

Fludarabine

Fludarabine 25mg/m\^2 IV on days -5 to -3

BIOLOGICAL

"Chimeric antigen receptor T cells to be implemented in a 3 + 3 design on day 0"

"Level -1 (1 x 105 cells/kg)~Level 1 \[Starting dose\] (5 x 105 cells/kg)~Level 2 (1 x 106 cells/kg)~Level 3 (2 x 106 cells/kg)"

Trial Locations (1)

05652-900

RECRUITING

Hospital Israelita Albert Einstein, São Paulo

Sponsors

Collaborators (1)

Miltenyi Biotec, Inc.
All Listed Sponsors
collaborator

Miltenyi Biotec, Inc.

INDUSTRY

lead

Nelson Hamerschlak

OTHER

NCT05705570 - Clinical Trial Using CAR- T Cells for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies | Biotech Hunter | Biotech Hunter