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Status unknownNCT04008251Updated Aug 7, 2019

Humanized CD19 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With B-cell Malignancies

A Phase 1 interventional study of Second generation humanized CAR-T cells in Acute Lymphoblastic Leukemia and B Cell Lymphoma, sponsored by Wuhan Sian Medical Technology Co., Ltd. Status unknown at 1 site in China. Open to participants aged 14 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-08-07.

Sponsored by Wuhan Sian Medical Technology Co., Ltd · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
14 Years to 70 Years
Sex
All
01

Study summary

This is a single arm, open-label study to evaluate the safety and efficacy of humanized anti-CD19 CAR-T cells in patients with relapsed or refractory B cell Malignancies.

Read the detailed description

Chimeric antigen receptor (CAR)-modified T cells (CAR-T cells) have the capabilities to recognize tumor associated antigen and kill tumor cells specifically. CAR-T therapy showed great effect on patients with relapsed or refractory B cell malignancies. To improve the efficacy and safety, the researchers designed a second-generation humanized CAR, consisting of humanized CD19 single chain variable fragment (scFv) and CD137 costimulatory domain. This study aims to evaluate the safety and effectiveness of humanized anti-CD19 CAR-T cells in patients with relapsed or refractory B cell Malignancies.

02

Conditions studied

  • Acute Lymphoblastic Leukemia
  • B Cell Lymphoma
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 10 is below 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

Wuhan Sian Medical Technology Co., Ltd is the lead sponsor of 4 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
14 Years to 70 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. The patient is pathologically and histologically confirmed as CD19 + B cell tumors, and has no effective treatment options currently, such as chemotherapy; or relapsed after auto-HSCT/allo-HSCT; or patients voluntarily choose CD19 CAR-T cells as a first treatment;

  2. B cell hematological malignancies include the following three categories:

    A. B-cell acute lymphocytic leukemia (B-ALL);

    B. Indolent B-cell lymphoma (CLL, FL, MZL, LPL);

    C. Aggressive B-cell lymphoma (DLBCL, BL, MCL);

  3. Aged from 14 to 70 years old;
  4. Expected survival time > 6 months;
  5. Female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit;
  6. Voluntarily participate in this experiment and sign informed consent by themself, or legally authorized representative.

Exclusion criteria

Exclusion Criteria:

  1. With a history of epilepsy or other central nervous system diseases;
  2. Having graft-versus-host reaction, requires the use of immunosuppressants;
  3. The presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within recent six months, or heart disease with cardiac function in any grade 3 (moderate) or 4 ( severe) (according to the New York Heart Association (NYHA) Functional Classification System);
  4. Pregnant or lactating women (safety of this therapy for the unborn child is unknown);
  5. Not curable active infection;
  6. Patients with active hepatitis B or hepatitis C virus infection;
  7. Combined use of systemic steroids within two weeks (except use of inhaled steroid recently or currently);
  8. Using product of gene therapy before;
  9. Creatinine> 2.5 mg / dl (221.0 umol/L); ALT / AST> 3 X the normal amount; Bilirubin> 2.0 mg / dl (34.2 umol/L);
  10. Patients suffering from other uncontrolled diseases, and researchers believe that the patient is not suitable for trial;
  11. Patients with HIV-infection;
  12. Any situation that may increase the risk of patients or interfere with test results.
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
    Second generation humanized CAR-T cells

    Patients receive humanized CD19 CAR-T cells transduced with a lentiviral vector on days 0/1/2 in the absence of disease progression or unacceptable toxicity.

    Genetic: Second generation humanized CAR-T cells

Interventions

  • GeneticSecond generation humanized CAR-T cells

    Patients receive humanized CD19 CAR-T cells transduced with a lentiviral vector on days 0/1/2 in the absence of disease progression or unacceptable toxicity.

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events

    Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)

    Time frame: 5 years

Secondary outcomes

  1. One-month remission rate

    Response of B-ALL to CAR-T therapy was assessed on day 30 (±2), against the National Comprehensive Cancer Network (NCCN, Version 1.2015).

    Time frame: 1 month

  2. Overall survival

    OS was calculated from the first CAR-T cell infusion to death or last follow-up (censored).

    Time frame: 5 years

  3. Event-free survival

    EFS was calculated from the first CAR-T cell infusion to death, progression of the disease, relapse or gene recurrence, whichever came first, or last visit (censored).

    Time frame: 5 years

  4. Relapse-free survival

    RFS was calculated from the first CAR-T cell infusion to relapse or last visit (censored).

    Time frame: 5 years

  5. Rate of anti-CD19 CAR-T cells in bone marrow cells and peripheral blood cells

    In vivo (bone marrow and peripheral blood) rate of CAR-T cells were determined by means of flow cytometry.

    Time frame: 5 years

  6. Quantity of anti-CD19 CAR-T cells in bone marrow cells and peripheral blood cells

    In vivo (bone marrow and peripheral blood) quantity of CAR-T cells were determined by means of flow cytometry.

    Time frame: 5 years

  7. Quantity of anti-CD19 CAR copies in bone marrow cells and peripheral blood cells

    In vivo (bone marrow and peripheral blood) quantity of anti-CD19 CAR copies were determined by means of qPCR.

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430022, China
    Recruiting
08

References and documents

Publications

  • Du M, Mayombo RTM, Liu J, Zhang Y, Liao D, Hu Y, Mei H. The impact of obesity and its related underlying diseases on cytokine release syndrome and the efficacy of CAR-T therapy in treating B-cell malignancies. Ann Hematol. 2025 Mar;104(3):1887-1895. doi: 10.1007/s00277-025-06338-6. Epub 2025 Apr 8. PubMed 40195173 ↗
  • Zhang Y, Zhou F, Wu Z, Li Y, Li C, Du M, Luo W, Kou H, Lu C, Mei H. Timing of Tocilizumab Administration Under the Guidance of IL-6 in CAR-T Therapy for R/R Acute Lymphoblastic Leukemia. Front Immunol. 2022 Jun 21;13:914959. doi: 10.3389/fimmu.2022.914959. eCollection 2022. PubMed 35799791 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2019 (actual). Primary completion is estimated for Jul 2022, 37 months after the start.

Of 67 industry-sponsored phase 1 interventional studies under Precursor Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 76. This study's planned 37 months is below that.

Counting every sponsor, half of 234 studies reached it within 55 months; a quarter within 34 and three quarters within 89.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2019
First posted
Jul 5, 2019
StartActual
May 27, 2019
Primary completionEst.
Jul 1, 2022
CompletionEst.
Dec 31, 2022
Last update
Aug 7, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04008251
Lead sponsor
Wuhan Sian Medical Technology Co., Ltd
Collaborators
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Jingzhou Central Hospital, Xiangyang Central Hospital, People Hospital Of Yichang
Responsible party
Sponsor
First posted
Jul 5, 2019
Start date
May 27, 2019
Primary completion
Jul 1, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Aug 7, 2019

Study contacts

Yu Hu, M.D., Ph.D
Contact
dr_huyu@126.com
86-13986183871
Heng Mei, M.D., Ph.D
Contact
hmei@hust.edu.cn
86-13886160811
Heng Mei, M.D., Ph.D
principal investigator · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Oversight

Data monitoring committee
No
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 Jul 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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