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Acute Lymphoblastic LeukemiaPhase 1NCT04008251

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

A Phase 1 study testing Second generation humanized CAR-T cells in people with Acute Lymphoblastic Leukemia and B Cell Lymphoma, run by Wuhan Sian Medical Technology Co., Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 14 to 70 years
Conditions the study is for
Acute Lymphoblastic Leukemia, B Cell Lymphoma
What is being tested?
Second generation humanized CAR-T cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
27 May 2019to 31 Dec 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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;
  • B cell hematological malignancies include the following three categories:
  • B-cell acute lymphocytic leukemia (B-ALL);
  • Indolent B-cell lymphoma (CLL, FL, MZL, LPL);
  • Aggressive B-cell lymphoma (DLBCL, BL, MCL);
  • Aged from 14 to 70 years old;
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  • Expected survival time > 6 months;
  • Female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit;
  • Voluntarily participate in this experiment and sign informed consent by themself, or legally authorized representative.

Who cannot join

  • With a history of epilepsy or other central nervous system diseases;
  • Having graft-versus-host reaction, requires the use of immunosuppressants;
  • 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);
  • Pregnant or lactating women (safety of this therapy for the unborn child is unknown);
  • Not curable active infection;
  • Patients with active hepatitis B or hepatitis C virus infection;
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  • Combined use of systemic steroids within two weeks (except use of inhaled steroid recently or currently);
  • Using product of gene therapy before;
  • 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);
  • Patients suffering from other uncontrolled diseases, and researchers believe that the patient is not suitable for trial;
  • Patients with HIV-infection;
  • Any situation that may increase the risk of patients or interfere with test results.

Trial locations and contacts

1 site in 1 country.

Yu Hu, M.D., Ph.D contact

86-13986183871

dr_huyu@126.com

Heng Mei, M.D., Ph.D contact

86-13886160811

hmei@hust.edu.cn

China1 site, 1 recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Yu Hu, M.D., Ph.D, 86-13986183871, dr_huyu@126.com

    Heng Mei, M.D., Ph.D, 86-13886160811, hmei@hust.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Treatment of Relapsed or Refractory B-cell Malignancies by Humanized CD19 Chimeric Antigen Receptor (CAR)-Modified T Cells

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.

Being tested
Second generation humanized CAR-T cells
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Second generation humanized CAR-T cellsGenetic

    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.

Study groups in NCT04008251
Study groupRoleWhat they receive
Second generation humanized CAR-T cellsExperimentalPatients 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.
Receives: Genetic: Second generation humanized CAR-T cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 5 years

Secondary outcomes (7)

  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).

    Measured: 1 month

  2. Overall survival

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

    Measured: 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).

    Measured: 5 years

  4. Relapse-free survival

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2019
  2. Study start27 May 2019
  3. Primary completion1 Jul 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04008251
Sponsor's protocol ID
CART-huCD19-01
Status last verified
Jul 2019
First submitted
1 Jul 2019
Last updated
7 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Second generation humanized CAR-T cells in people with Acute Lymphoblastic Leukemia and B Cell Lymphoma, run by Wuhan Sian Medical Technology Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yu Hu, M.D., Ph.D (86-13986183871, dr_huyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04008251, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.

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