piggyBac transposon mediated chimeric antigen receptor gene modified T cells for CD19 positive acute lymphoblastic leukemia

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTa040190099

Enrollment

Registered

2019-12-18

Start date

2018-07-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CD19 positive acute lymphoblastic leukemia

Interventions

Administration of CAR-T cells produced from autologous peripheral blood

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) CD19 positive ALL 2) chemo-refractory/relapsed after allogeneic stem cell transplantation 3) 1-60 years old* 4) Written informed consent from patient or legal representative 5) Fulfill all of the following criteria: i) Performance status (PS) score: 0-3 ii) AST==90% (room air) *Cohort 1: 16-60 years old, Cohort 2: 1-15 years old

Exclusion criteria

Exclusion criteria: 1) predonisolone use >=0.5 mg/kg/day 2) BM blast >=20% 3) CNS-3 4) severe or uncontrollable infection 5) severe or uncontrollable GVHD 6) severe or uncontrollable heart failure 7) previous use of CAR-T therapy 8) Psychoses 9) History of allergic reaction to albumin 10) History of allergic reaction to mouse derived protein

Design outcomes

Primary

Measure	Time frame
Incidence of DLT (specified below) occurring until completion of CAR-T therapy. 1,Grade 4 or higher non-hematological toxicities with causality to the therapy not ruled out 2,Grade 4 or higher toxicities judged related to or caused by cytokine release syndrome 3,Grade 4 GVHD 4,Grade 3 non-hematological toxicities with causality to the therapy not ruled out or Grade 3 toxicities judged related to or caused by cytokine release syndrome, with no improvement to Grade 2 or lower within 4 weeks after infusion	—

Measure

Time frame

Incidence of DLT (specified below) occurring until completion of CAR-T therapy. 1,Grade 4 or higher non-hematological toxicities with causality to the therapy not ruled out 2,Grade 4 or higher toxicities judged related to or caused by cytokine release syndrome 3,Grade 4 GVHD 4,Grade 3 non-hematological toxicities with causality to the therapy not ruled out or Grade 3 toxicities judged related to or caused by cytokine release syndrome, with no improvement to Grade 2 or lower within 4 weeks after infusion

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Secondary

Measure	Time frame
1,Change of CAR-T cell counts CAR-T cells in blood and bone marrow will be counted over time until completion of CAR-T therapy by real time PCR assay and flow cytometry. 2,Change of ALL blast counts ALL blast (%) in blood and bone marrow will be counted. If available, ALL DNA and RNA levels in blood and bone marrow will be measured over time by real time PCR assay or next generation sequencer. Among all treated patients, those who presented blast response to the infusion will be recorded. 3,Disease state of ALL before and after CAR-T therapy (at 26 to 30 days after CAR-T infusion)	—

Measure

Time frame

1,Change of CAR-T cell counts CAR-T cells in blood and bone marrow will be counted over time until completion of CAR-T therapy by real time PCR assay and flow cytometry. 2,Change of ALL blast counts ALL blast (%) in blood and bone marrow will be counted. If available, ALL DNA and RNA levels in blood and bone marrow will be measured over time by real time PCR assay or next generation sequencer. Among all treated patients, those who presented blast response to the infusion will be recorded. 3,Disease state of ALL before and after CAR-T therapy (at 26 to 30 days after CAR-T infusion)

—

Countries

Japan

Contacts

Public ContactKenji Hayashi

Nagoya University Hospital

ethics@med.nagoya-u.ac.jp+81-52-744-2479

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026