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RecruitingNCT03064269Updated Nov 29, 2023

CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia

A Phase 1 interventional study of CD19 CAR-T cells in B-cell Acute Lymphocytic Leukemia, sponsored by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd. Recruiting at 1 site in China. Open to participants aged 10 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Mar 2017; still recruiting 9 years 7 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
10 Years to 60 Years
Sex
All
01

Study summary

This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.

Read the detailed description

CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells

02

Conditions studied

  • B-cell Acute Lymphocytic Leukemia

Keywords

  • CNS B cell acute lymphocytic leukemia
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 10 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd is the lead sponsor of 14 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia
  2. ALT/ AST 《 3x normal
  3. Creatinine 《 3x normal
  4. Age:10-60.
  5. Signed informed consent

Exclusion criteria

Exclusion Criteria:

  1. Active hepatitis B , hepatitis C or HIV infection
  2. Uncontrolled active infection
  3. Pregnancy or breast-feeding women
  4. Survival less than four weeks
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Arm 1

    CD19 CAR-T cells treated central nervous system B-cell acute lymphocytic leukemia.

    Biological: CD19 CAR-T cells

Interventions

  • BiologicalCD19 CAR-T cells

    CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells

06

What researchers measure

Primary outcomes

  1. The complete remission (CR) rate

    The safety of the humanized CD19 CAR-T cells treatment will be evalated and the maximum tolerated dose will be determined

    Time frame: Participants will be followed for the duration of the treatment, an expected average of 12 months

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Soochow University
    Suzhou, China
    Recruiting
08

References and documents

Publications

  • Chen LY, Kang LQ, Zhou HX, Gao HQ, Zhu XF, Xu N, Yu L, Wu DP, Xue SL, Sun AN. Successful application of anti-CD19 CAR-T therapy with IL-6 knocking down to patients with central nervous system B-cell acute lymphocytic leukemia. Transl Oncol. 2020 Nov;13(11):100838. doi: 10.1016/j.tranon.2020.100838. Epub 2020 Jul 31. PubMed 32745961 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03064269
Lead sponsor
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Collaborators
The First Affiliated Hospital of Soochow University
Responsible party
Sponsor
First posted
Feb 27, 2017
Start date
Mar 1, 2017
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Nov 29, 2023

Study contacts

Sheng-Li Xue, MD
Contact
slxue@suda.edu.cn
86-13328008851
Lei Yu, Ph.D
Contact
ylyh188@163.com
86-13818629089
Sheng-Li Xue, Ph.D
principal investigator · The First Affiliated Hospital of Soochow University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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