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LymphomaPhase 1EECPLNCT03086954

Study Evaluating the Efficacy and Safety With CAR-T Immunotherapy for CD19 Positive Lymphoma

A Phase 1 study testing The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) in people with Lymphoma, run by Sinobioway Cell Therapy 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 The sponsor has not verified this record for over two years, so it may be out of date.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 open, single-arm,multicenter 2 phase clinical study will treat the patient who have CD19 positive lymphoma with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor(CAR)that will bind to tumour cells modified to express the CD19 protein on the cell… Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Lymphoma
What is being tested?
The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
Apr 2017to Mar 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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 1.Age older than 16 years old,gender and race no limited.
  • 2.Pathological diagnosis of CD19 express positive recurrent or refractory B lymphoma, satisfy any of the following a diagnosis of recurrent or refractory lymphoma: (1) According to the standard solution standardization more than four courses of treatment, tumor size < 50% or progression;(2) According to the standard solution treatment of complete remission, after recurrence again with the original plan or the national expert consensus recommended second-line cannot again get to complete remission (3) Relapse after hematopoietic stem cell transplantation.
  • 3.Patients into the group needs lesions to be available for testing or evaluating disease.
  • 4.ECOG score reaches 0 to 1 points.
  • 5.Patients into the group of White Blood Cell counts in peripheral blood acuity≥ 1.0 x10^9 / L.
  • 6.Estimated survival times > 90 days.
  • 7.Patients have self-knowledge ability, can sign the informed consent form.

Who cannot join

  • 1.Pregnant or lactating women.
  • 2.Uncontrolled infection.
  • 3.HIV infection, hepatitis B or C activity period.
  • 4.Patients who need long-term immunosuppressive therapy (Such as allergies, autoimmune diseases, GVHD, etc.)
  • 5.Combined activity of the central nervous system malignant tumor invasion.
  • 6.Abnormal coagulation function, patients with severe thrombosis.
Show all 9Show fewer
  • 7. Organ failure Heart：class Ⅱ or above. Liver：class Ⅱ or above( Refer to Classification of Wuhan Conference (1983)). Kidney: The second stage of renal insufficiency or above. Lung: class Ⅱdecreased slightly or above. Brain: The central nervous system transfer or have active lesions.
  • 8.Patients who have participated in other clinical trials in the past 30 days or or participate in other clinical trials at the same time.
  • 9.Investigator believe that the patient is not suitable to participate in the study.

Trial locations and contacts

1 site in 1 country.

Jifeng Feng, Professor contact

13901581264

fjif@vip.sina.com

China1 site

  • Jiangsu Cancer hospital

    Nanjing, Jiangsu, 210000

    Jifeng Feng, Professor, 13901581264, fjif@vip.sina.com

Other trials in China

About this study

Official title: Open, Single Arm,Multicenter Phase 2 Clinical Study to Evaluating the Efficacy and Safety of the Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) for CD19 Positive Lymphoma

This open, single-arm,multicenter 2 phase clinical study will treat the patient who have CD19 positive lymphoma with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor(CAR)that will bind to tumour cells modified to express the CD19 protein on the cell surface. The study will determine if these modified T cells help the body's immune system eliminate tumour cells .The trial will also study the safety of treatment for CAR-T, how long CAR-T cells stay in the patient's body and the impact on this treatment for survival.

Read the detailed description

This is an open, single-arm,multicenter 2 phase clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of CD19 positive lymphoma. The study will be conducted using a phaseⅠ/Ⅱdesign the study will have the following sequential phases: part A (screening, leukapheresis, cell product preparation and cytoreductive chemotherapy) and part B (treatment and follow-up). The follow-up period for each participant is approximately 35 months after the final CAR-T infusion. The total duration of the study are expected to be approximately 3 years. A total of 24 patients may be enrolled over a period of 3 years.

Conditions
Lymphoma
Being tested
The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T)
Keywords
CD19 positive lymphoma
Medical subject headings
Lymphoma

What participants receive

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

  • The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T)Biological

    This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months.

Study groups in NCT03086954
Study groupRoleWhat they receive
single armExperimentalName:The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage:100ml/time Frequency:The first day,the second day,29 days,injection once a day in this three days Duration:Only injection three times
Receives: Biological: The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T)

What is being measured

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

  1. The objective reaction rate of patients with CD19 positive lymphoma after autologous CAR-T cell therapy.

    The objective reaction rate will be determined by the evaluation of CT/PET-CT.Evaluation of the objective reaction rate according to the non-hodgkin's lymphoma curative effect evaluation criteria of international lymphoma group. The objective reaction rate = (complete remission (CR) number + partial remission (PR) number / total number of cases receiving treatment.

    Measured: up to 90 days

Secondary outcomes (4)

  1. Progression free survival time

    From patients into the group to the interval between disease progression or death.

    Measured: 3years

  2. Overall survival time

    From all patients into the group to the interval between death caused by any reason .

    Measured: 3years

  3. Patients - -based Quality of Life Evaluation

    According to the EORTC quality of life of the core scale criteria QLQ-C30(V3.0) to evaluate patients life quality.

    Measured: 3years

  4. 3°or above incidence rate of serious adverse reaction related to treatment

    According to CTCAE v4.0 to evaluate incidence rate of serious adverse reaction.

    Measured: 3years

Timeline

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

  1. First posted22 Mar 2017
  2. Study startApr 2017 (estimated)
  3. Primary completionMar 2021 (estimated)
  4. Study completionMar 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
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03086954
Sponsor's protocol ID
WM-CART-02
Acronym
EECPL
Status last verified
Mar 2017
First submitted
13 Mar 2017
Last updated
22 Mar 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Turtle CJ, Hanafi LA, Berger C, Hudecek M, Pender B, Robinson E, Hawkins R, Chaney C, Cherian S, Chen X, Soma L, Wood B, Li D, Heimfeld S, Riddell SR, Maloney DG. Immunotherapy of non-Hodgkin's lymphoma with a defined ratio of CD8+ and CD4+ CD19-specific chimeric antigen receptor-modified T cells. Sci Transl Med. 2016 Sep 7;8(355):355ra116. doi: 10.1126/scitranslmed.aaf8621.

    PubMed 27605551

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) in people with Lymphoma, run by Sinobioway Cell Therapy 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 7 inclusion and 9 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 22 Mar 2017. 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 Jifeng Feng, Professor (13901581264, fjif@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The objective reaction rate of patients with CD19 positive lymphoma after autologous CAR-T cell therapy. (time frame: up to 90 days). 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 NCT03086954, which also lists 1 linked publication.

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 22 Mar 2017.

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EECPL Clinical Trial NCT03086954 | AzTrials