NCT06447987View on ClinicalTrials.gov

Humanized CD19-Specific CAR T Cells for the Treatment of Patients With Positive Relapsed or Refractory CD19 Positive B-Cell Acute Lymphoblastic Leukemia

PHASE1RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

November 6, 2024

Primary Completion Date

December 5, 2026

Study Completion Date

December 5, 2026

Conditions
Recurrent Acute Lymphoblastic LeukemiaRefractory Acute Lymphoblastic Leukemia
Interventions
PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo alloHCT

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

BIOLOGICAL

CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes

Given IV

BIOLOGICAL

Cetuximab

Given IV

PROCEDURE

Computed Tomography

Undergo CT and PET

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Echocardiography

Undergo ECHO

DRUG

Fludarabine

Given IV

PROCEDURE

Leukapheresis

Undergo leukapheresis

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Trial Locations (1)

91010

RECRUITING

City of Hope Medical Center, Duarte

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

City of Hope Medical Center

OTHER