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Leukemia, B-CellPhase 1NCT03599375

Immunotherapy With CD19 CART-cells for B Cell Acute Lymphoblastic Leukemia

A Phase 1 study testing CD19-targeted CART cells in people with Leukemia, B-Cell, run by jiuwei cui.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 study aims to evaluate the safety and clinical activity of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in treating patients with recurrent or refractory CD19 positive B cell ccute lymphoblastic leukemia,and dynamically observe the changes of CAR-T in patients and the residual tumor. Read more about this study

Who is it for?
Ages 14 to 75 years
Conditions the study is for
Leukemia, B-Cell
What is being tested?
CD19-targeted CART cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
1 May 2019to 30 Dec 2021
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 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Recurrent or refractory B cell derived acute lymphoblastic leukemia (ALL)
  • Patients who have failed at least one line of a standard treatment without effective treatment measures at present
  • CD19 expression on the surface of B-ALL cells must be detected
  • KPS>80
  • Life expectancy >3 months
  • Patients must have adequate cardiac function (no electrocardiogram with obvious abnormality, LVEF≥50%),adequate pulmonary function as indicated by room air oxygen saturation of > 90%, and adequate renal function (Cr≤2.5 times of the normal range)
Show all 10Show fewer
  • The alanine aminotransferase (ALT) and the aspartate aminotransferase (AST)≤ 3 times of the normal range, and the total bilirubin (TBIL)≤2.0mg/dl(34.2umol/L)
  • Hemoglobin(Hgb)≥80g/L
  • Without contraindication of apheresis and cell isolation
  • Patients and their families volunteer to participate in the research with signed written informed consent

Who cannot join

  • .Other concurrent severe and/or uncontrolled medical conditions: patients with another primary malignant disease; another severe and/or life-threatening medical disease.
  • Evidence of uncontrolled current serious active infection
  • HIV/HBV/HCV infection
  • Pregnancy and nursing females
  • Systemic glucocorticoid therapy within one week

About this study

Official title: Safety and Clinical Activity of CD19 Chimeric Antigen Receptor T Cells in Treating Patients With Recurrent or Refractory CD19 Positive B Cell Acute Lymphoblastic Leukemia

This study aims to evaluate the safety and clinical activity of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in treating patients with recurrent or refractory CD19 positive B cell ccute lymphoblastic leukemia,and dynamically observe the changes of CAR-T in patients and the residual tumor.

Read the detailed description

In this single-center, open-label, single-arm, prospective clinical trial, a total of 20 recurrent or refractory CD19+ B cell acute lymphoblastic leukemia patients will be enrolled.After recruiting eligible patients,autologous peripheral blood mononuclear cells(PBMCs) will be purified from whole blood.The CD3+ T cells were subsequently selected and re-stimulated by anti-CD3 and anti-CD28 monoclonal antibodies.T cells will be transduced with lentiviral vector for the generation of the CD19 CART cell and administered by i.v. injection.The purpose of current study is to determine the safety and clinical efficacy of CD19 CAR T cells therapy in patients with recurrent or refractory CD19+ ALL.

Being tested
CD19-targeted CART cells
Keywords
Chimeric Antigen Receptor-Modified T Cells, CART, Recurrent B Cell Acute Lymphoblastic Leukemia, refractory B Cell Acute Lymphoblastic Leukemia, ALL
Medical subject headings
Leukemia, B-Cell, Burkitt Lymphoma

What participants receive

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

  • CD19-targeted CART cellsBiological

    CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv.This is a second generation CRAT.

Study groups in NCT03599375
Study groupRoleWhat they receive
B-ALL treated with CD19 CART cellExperimentalThe qualified CD19-targeted CART cells will be transferred to patient for 3 days as follow:D1,10% fraction;D2,30%;D3 60%. The number of CART cells for each course will be about 1×106/kg. If complete response (CR) or complete response with incomplete hemogram recovery (CRi) in hemogram is achieved after the first course of treatment, further treatment will be decided according to the clinical assessment and the wishes of the patient.If partial response (PR) is achieved after the first course, 1 or 2 courses of treatment will be continued. If there is no response (NR) after the first course, the treatment will be ceased or restarted based on the clinical assessment or patients' wishes. Treatent may be discontinued due to any severe toxicity, such as cytokine release syndrom.
Receives: Biological: CD19-targeted CART cells

What is being measured

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

  1. overall response rate(ORR)

    ORR is defined as the proportion of partial responses plus complete responses.

    Measured: Participants will be followed for the duration of the treatment, with an expected average of 3 months.

Secondary outcomes (2)

  1. Progression free survival(PFS)

    Progression-free survival is defined as the time from enrollment to first observation of progression or date of death (from any cause).

    Measured: 15 years

  2. Overall survival(OS)

    Overall survival, defined as the time from enrollment until death due to any cause. For patients who do not die, time to death will be censored at the time of last contact.

    Measured: 15 years

Timeline

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

  1. First posted26 Jul 2018
  2. Study start1 May 2019 (estimated)
  3. Primary completion30 Dec 2020 (estimated)
  4. Study completion30 Dec 2021 (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
Model description
Patients with recurrent or refractory CD19+ ALL receive CD19 CAR T-cell immunotherapy.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03599375
Sponsor's protocol ID
FJLU-002
Status last verified
Feb 2019
First submitted
15 Jul 2018
Last updated
26 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CD19-targeted CART cells in people with Leukemia, B-Cell, run by jiuwei cui.

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 10 inclusion and 5 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 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

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?

overall response rate(ORR) (time frame: Participants will be followed for the duration of the treatment, with an expected average of 3 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 NCT03599375.

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 26 Feb 2019.

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