ClinicalTrials.gg
Sign In
Status unknownNCT03275493Updated May 28, 2024

CD19 CAR-T Cells With CRS Suppression Technology for r/r CD19+ Acute Lymphoblastic Leukemia

A Phase 1/2 interventional study of CD19 CAR-T cells and CD19 CAR-T cells with CRS suppression technology in Acute Lymphoblastic Leukemia, CD19 Positive and Relapse, sponsored by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd. Status unknown at 1 site in China. Open to participants aged 6 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-28.

Sponsored by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
6 Years to 65 Years
Sex
All
01

Study summary

This is a single center,randomized ,two-cohorts, open-label ,phase 1/2 study to evaluate the efficacy and safety of T cells expressing CD19 chimeric antigen receptors treatment for relapsed/refractory CD19+ acute lymphoblastic leukemia patients.

Read the detailed description

Relapsed/refractory CD19 + acute lymphoblastic leukemia patients were randomly enrolled in this study to compare the efficacy and safety between two cohorts: 1. CD19 CAR-T cells； 2. CD19 CAR-T cells with CRS suppression technology.

02

Conditions studied

  • Acute Lymphoblastic Leukemia
  • CD19 Positive
  • Relapse
  • Refractory

Keywords

  • CD19+ ,CAR-T, CRS
03

In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,121 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 492 are open to participants now.

This study's planned enrollment of 40 is close to the median of 40 across 1,691 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd is the lead sponsor of 15 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
6 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 6 to 65
  2. Voluntary informed consent is given
  3. Expected survival ≥12 weeks
  4. Relapsed or refractory CD19+ acute leukemia, ineligible for allo-HSCT,or relapse after auto-HSCT
  5. Organ function: (1)Left ventricular ejection fractions≥ 0.6 by echocardiography (2)ALT ≤3 times of ULN, or bilirubin \<2.0 mg/dl (3)Creatinine \< 2 mg/dl and less than 2.5 × normal for age (4)Prothrombin time and activated partial thromboplastin time \< 2 times of ULN (5)Arterial oxygen saturation> 92%
  6. Karnofsky score ≥ 60 ;
  7. No history of combined chemotherapy in the recent 1 month and no immunotherapy in the recent 3 months;

Exclusion criteria

Exclusion Criteria:

  1. Uncontrolled active infections
  2. Active hepatitis B or hepatitis C infection
  3. HIV infection
  4. History of myocardio infarction in the past 6 months, or history of severe arrhythmia
  5. Congenital immunodeficiency
  6. Pregnant or lactating women
  7. History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
  8. Previous treatment with any gene therapy products
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Experimental: Cohort 1

    This cohort will determine the safety and efficacy of CD19 CAR-T cells for CD19+ acute lymphoblastic leukemia

    Biological: CD19 CAR-T cells

  • Experimental
    Experimental: Cohort 2

    This cohort will determine the safety and efficacy of CD19 CAR-T cells with CRS suppression technology for CD19+ acute lymphoblastic leukemia.

    Biological: CD19 CAR-T cells with CRS suppression technology

Interventions

  • BiologicalCD19 CAR-T cells

    Express a Second Generation 4-1BB: CD19 CAR-T cells

  • BiologicalCD19 CAR-T cells with CRS suppression technology

    Express a Second Generation 4-1BB:CD19 CAR-T cells with CRS suppression technology

06

What researchers measure

Primary outcomes

  1. Incidence of severe CRS

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

    Time frame: 30 days after infusion of CD19 CAR-T cells

Secondary outcomes

  1. Overall response of CD19 CAR-T cells treatment who achieve morphology complete remission(CR) and MRD negativity.

    The efficacy of the CD19 CAR-T cells infusion will be estimated based on the number of participants who have morphology complete remission(CR) and MRD negativity following the CD19 CAR- T cells infusion

    Time frame: 30 days after infusion of CD19 CAR-T cells

07

Study locations

1 of 1 sites recruiting
  • The first affiliated hospital of soochow university
    Suzhou, Jiangsu 200000, China
    • Shengli Xue, MD · Contact
    Recruiting
08

References and documents

Publications

  • Gong WJ, Qiu Y, Li MH, Chen LY, Li YY, Yu JQ, Kang LQ, Sun AN, Wu DP, Yu L, Xue SL. Investigation of the risk factors to predict cytokine release syndrome in relapsed or refractory B-cell acute lymphoblastic leukemia patients receiving IL-6 knocking down anti-CD19 chimeric antigen receptor T-cell therapy. Front Immunol. 2022 Aug 29;13:922212. doi: 10.3389/fimmu.2022.922212. eCollection 2022. PubMed 36105799 ↗
  • Hua J, Zhang J, Zhang X, Wu X, Zhou L, Bao X, Han Y, Miao M, Li C, Fu C, Chen S, Tang X, Wu D, Qiu H. Donor-derived anti-CD19 CAR T cells compared with donor lymphocyte infusion for recurrent B-ALL after allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2021 May;56(5):1056-1064. doi: 10.1038/s41409-020-01140-6. Epub 2020 Nov 24. PubMed 33235353 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03275493
Lead sponsor
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Collaborators
The First Affiliated Hospital of Soochow University
Responsible party
Sponsor
First posted
Sep 7, 2017
Start date
Jul 1, 2017
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
May 28, 2024

Study contacts

Xiaowen Tang, PhD
Contact
tangxiaowen@suda.edu.cn
8651267781525
Lei Yu, PhD
Contact
ylyh188@163.com
8613818629089
Xiaowen Tang, PhD
principal investigator · The First Affiliated Hospital of Soochow University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Precursor Cell Lymphoblastic Leukemia-Lymphoma →

Other studies from this sponsor

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Start the discussion