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Acute Lymphoblastic Leukemia, Adult B-CellPhase 1NCT02975687

CD19 CAR T Cells in Patients With Resistant or Refractory CD19+ Acute Lymphoblastic Leukemia

A Phase 1 study testing CD19 CAR T cells in people with Acute Lymphoblastic Leukemia, Adult B-Cell and Acute Lymphoblastic Leukaemia Recurrent, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this single-center, open-label, no control, prospective clinical trial, a total of 20 resistant or refractory CD19+ B cell acute lymphoblastic leukemia (ALL) patients will be enrolled. CD19 CAR T cells will be administered by i.v. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
CD19 CAR T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
Nov 2016to 31 Dec 2018
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18 to 70 years with relapsed or refractory CD19 positive ALL(ie, ≥20% blasts CD19-positive) due to receive either salvage 1 or salvage 2 therapy. Ph+ ALL patients must have failed treatment with at least 1 second generation tyrosine kinase inhibitor.
  • Bone marrow involvement with≥20% lymphoblasts.
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
  • Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum glutamic-oxaloacetic transaminase(SGOT) and serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN or any serum creatinine level associated with a measured or calculated creatinine clearance of ≥ 40ml/min.
  • Patients should sign informed consent form.

Who cannot join

  • Isolated extramedullary relapse.
  • Active central nervous system leukemia.
  • Prior chemotherapy within ≤2 weeks before enrollment with the following exceptions: steroids, hydroxyurea, oral mercaptopurine, methotrexate, vincristine, thioguanine, and tyrosine kinase inhibitors are permitted within 2 weeks of enrollment as maintenance or to reduce the peripheral blood blast count. Patients must have recovered from acute toxicity of all previous therapy prior to enrollment.
  • Prior allogeneic hematopoietic stem cell transplant (HSCT) ≤ 4 months before enrollment. Patients must have completed immunosuppression therapy prior to enrollment. At enrollment, patients must not have > grade 2 acute GVHD, or either moderate or severe limited chronic GVHD, or extensive GVHD of any severity.
  • Peripheral lymphoblasts > 10,000/μl (treatment with hydroxyurea and/or steroids is permitted within 2 weeks of enrollment to reduce the WBC count).
  • Known systemic vasculitides, primary or secondary immunodeficiency(such as HIV infection or severe inflammatory disease).
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  • Major surgery within ≤ 4 weeks before enrollment.
  • Impaired cardiac function:Ejection fraction < 45 % on MUGA scan. QTc interval > 450 msec on baseline ECG (using the QTcB formula). If QTcB interval>450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc. Myocardial infarction within 6 months prior to starting study; other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension, uncontrolled arrhythmias).
  • Administration of live vaccine ≤ 4 weeks before enrollment.
  • Other concurrent severe and/or uncontrolled medical conditions:
  • Patients with another primary malignant disease, except those that do not currently require treatment; acute or chronic liver, pancreatic or severe renal disease; another severe and/or life-threatening medical disease.
  • Evidence of uncontrolled current serious active infection.
  • Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to baseline and (d) male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial (post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
  • Who is known human deficiency virus (HIV) positive.
  • Use of any other investigational agent in the last 30 days.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, 300020

Other trials in China

About this study

In this single-center, open-label, no control, prospective clinical trial, a total of 20 resistant or refractory CD19+ B cell acute lymphoblastic leukemia (ALL) patients will be enrolled. CD19 CAR T cells will be administered by i.v. injection as a using a "split dose" (total dose of 5x10^6/kg-5x10^7/kg) approach to dosing:10% on day 0, 30% on day 1 and 60% on day 2. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells in patients with chemotherapy resistant or refractory CD19+ ALL.

Read the detailed description

In this single-center, open-label, nonrandomized, no control, prospective clinical trial, a total of 20 resistant or refractory CD19+ B cell acute lymphoblastic leukemia (ALL) patients will be enrolled. Patients will be diagnosed according to morphologic, immunologic, cytogenetic and molecular(MICM) criteria, including bone marrow morphology, immunophenotype, cytogenetic and molecular examination. CD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB,administered by i.v. injection as a using a "split dose" (total dose of 5x10^6/kg-5x10^7/kg) approach to dosing:10% on day 0, 30% on day 1 and 60% on day 2. This protocol will be given to subjects with unmet medical needs for which there are no effective therapies known at this time. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with chemotherapy resistant or refractory CD19+ ALL.

Being tested
CD19 CAR T cells
Keywords
Acute, Leukemia, Lymphoid, CD19, Refractory
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia

What participants receive

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

  • CD19 CAR T cellsBiological

    CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB.

Study groups in NCT02975687
Study groupRoleWhat they receive
Arm AExperimentalCD19 CAR T cells will be administered by i.v. injection as a using a "split dose" (total dose of 5x10^6/kg-5x10^7/kg) approach to dosing:10% on day 0, 30% on day 1 and 60% on day 2.
Receives: Biological: CD19 CAR T cells

What is being measured

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

  1. The complete remission (CR) rate

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

Secondary outcomes (4)

  1. Disease-free survival (DFS)

    Measured: From the date of complete remission(CR) until the date of documented relapse,assessed up to 60 months.

  2. Number of adverse event of CD19 CAR T cells treatment

    Measured: Participants will be followed for the duration of the treatment, an expected average of 24 months.

  3. Grade of adverse event of CD19 CAR T cells treatment

    Measured: Participants will be followed for the duration of the treatment, an expected average of 24 months.

  4. Duration of in vivo survival of CD19 CAR T cells.

    Measured: Participants will be followed for the duration of the treatment, an expected average of 24 months.

Timeline

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

  1. First posted29 Nov 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionDec 2018
  4. Study completion31 Dec 2018

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02975687
Sponsor's protocol ID
QT2016002
Other IDs
HY001001
Status last verified
Jul 2019
First submitted
23 Nov 2016
Last updated
3 Jun 2025
Results posted
No

Publications

  • Krawczyk M, Druzynska M, Bednarska E, Winiarska M. The race between 4-1BB- and CD28-based CD19 CAR-T products in the therapy of B-cell malignancies. Biochim Biophys Acta Rev Cancer. 2026 Feb;1881(1):189519. doi: 10.1016/j.bbcan.2025.189519. Epub 2025 Dec 20.

    PubMed 41429239

  • Gu R, Liu F, Zou D, Xu Y, Lu Y, Liu B, Liu W, Chen X, Liu K, Guo Y, Gong X, Lv R, Chen X, Zhou C, Zhong M, Wang H, Wei H, Mi Y, Qiu L, Lv L, Wang M, Wang Y, Zhu X, Wang J. Efficacy and safety of CD19 CAR T constructed with a new anti-CD19 chimeric antigen receptor in relapsed or refractory acute lymphoblastic leukemia. J Hematol Oncol. 2020 Sep 7;13(1):122. doi: 10.1186/s13045-020-00953-8.

    PubMed 32894185

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CD19 CAR T cells in people with Acute Lymphoblastic Leukemia, Adult B-Cell and Acute Lymphoblastic Leukaemia Recurrent, run by Institute of Hematology & Blood Diseases Hospital, China 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 5 inclusion and 15 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: finished, as of the sponsor's last update on 3 Jun 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The complete remission (CR) rate (time frame: Participants will be followed for the duration of the treatment, an expected average of 12 months.). 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 NCT02975687, 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 3 Jun 2025.

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