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

Phase 1

Recruiting

• Conditions: CD19 positive acute lymphoblastic leukemia

• Registration Number: JPRN-jRCTa040190099
• Lead Sponsor: Takahashi Yoshiyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12

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=<5 x upper normal limit (UNL)
iii) ALT=<5 x UNL
iv) total bilirubin =<3 x UNL
v) serum creatinine =<3 x UNL
vi) SpO2>=90% (room air)
*Cohort 1: 16-60 years old, Cohort 2: 1-15 years old

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified