CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia

ConditionsAcute Lymphoblastic Leukemia Recurrent Acute Lymphoblastic Leukemia Recurrent B Acute Lymphoblastic Leukemia

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

AgeUp to 21

SponsorSt. Jude Children's Research Hospital

About this trial

This study is a phase I study designed to evaluate the safety of CD19-CD22-CAR T cells.

Primary Objective:

To determine the safety profile and propose the recommended phase 2 dose (RP2D) of autologous CD19-CD22-CAR T cells in patients ≤ 21 years of age with recurrent/refractory CD19- and/or CD22-positive leukemia.

Secondary Objective:

To evaluate the anti-leukemic activity of CD19-CD22-CAR T cells.

Eligibility criteria

Qualifiers

Age <21 years old

Second or greater relapse

Any relapse after allogeneic HCT

Refractory disease (primary or in relapse) despite therapy designed to induce remission

Disqualifiers

Known primary immunodeficiency

Known HIV positivity

Known contraindication to receiving protocol defined lymphodepleting

chemotherapy regimen

Trial design

Treatments tested in this trial

Fludarabine
Cyclophosphamide
Mesna
CD19-CD22 CAR T cell infusion

Treatment groups

30 Participants

are divided into 1 treatment group

Sponsors and collaborators

St. Jude Children's Research Hospital

Lead sponsor

Source ClinicalTrials.gov