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AzTrials

CD19-positivePhase 1NCT03720457

Human CD19 Targeted T Cells Injection(CD19 CAR-T) Therapy for Relapsed and Refractory CD19-positive Lymphoma.

A Phase 1 study testing Human CD19 targeted T Cells Injection in people with CD19-positive and Diffuse Large B-cell Lymphoma, run by Hrain Biotechnology Co., Ltd. at 3 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To evaluate the safety and tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive diffuse large B-cell lymphoma and follicular lymphoma. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Human CD19 targeted T Cells Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
3 sitesChina
Study dates
13 Nov 2018to Oct 2023
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

  • Male or female subjects with CD19+ B cell lymphomas who have a limited prognosis (several months to <2 year survival) with currently available therapies will be enrolled.
  • 18 to 70 Years Old, Male and female;
  • Expected survival > 12 weeks;
  • Clinical performance status of ECOG score 0-1;
  • Pathology demonstrated that CD19-positive B-cell non-Hodgkin's lymphoma and who meet one of the following conditions:
  • Relapsed and refractory CD19-positive Diffuse large B-cell lymphoma and Follicular lymphoma: patients previously received at least first-line and second- line treatment and fail to achieve CR;
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  • Disease recurrence after stem cell transplantation, and at least 1 years after stem cell transplantation.
  • It can establish the venous access required for collection, satisfying hemoglobin ≥ 70 g / L, neutrophils ≥ 1.0 × 10 ^ 9 / L, platelets ≥ 50 × 10 ^ 9 / L. Mononuclear cell collection can be determined by the investigators;
  • At least 1 measurable tumor foci according to the 2014 Lugano treatment response criteria;
  • Liver, kidney and cardiopulmonary functions meet the following requirements:
  • Serum creatinine ≤ 1.5 × ULN;
  • Left ventricular ejection fraction >50%, no pericardial effusion and no pleural effusion (ECHO examination);
  • Baseline oxygen saturation > 92%;
  • Total bilirubin ≤ 1.5 × ULN;
  • ALT and AST ≤ 3 × ULN.
  • Able to understand and sign the Informed Consent Document.

Who cannot join

  • In the first 5 years before screening, there are malignant tumors other than diffuse large B-cell lymphoma and follicular lymphoma, except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery，and catheter carcinoma in situ after radical surgery;
  • Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer higher than the upper limit of detection; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency Viral (HIV) antibody positive; Positive syphilis test;
  • Any unstable systemic disease including, but not limited to, active infection (except for local infection), unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ III), severe arrhythmia , liver, kidney or metabolic disease requiring medication;
  • Any other diseases could affect the outcome of this trial;
  • Any affairs could affect the safety of the subjects or outcome of this trial;
  • Pregnant or lactating women, or planned pregnancy during treatment or within 1 year after treatment, or a male subject whose partner plans pregnancy within 1 year of their cell transfusion;
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  • Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
  • Subjects who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell transfusion;
  • Received CAR-T treatment or other gene therapies before enrollment;
  • Patients with symptoms of central nervous system or brain metastasis or have received treatment for central nervous system or brain metastasis (radiotherapy, surgery or other treatment) within 3 months before enrollment;
  • Subject suffering disease affects the understanding of informed consent or comply with study protocol;
  • The investigators consider other conditions unsuitable for enrollment.

Trial locations and contacts

3 sites in 1 country.

Hongliang Fang, Dr. contact

021-58552006

fanghongliang@dashengbio.com

China3 sites, 3 recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Qingming Wang, M.D., 0791-86300483, wqming222@163.com

    Recruiting

  • Fudan University Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200000

    Peng Liu, Professor, 021-60267405, Liu.peng@zs-hospital.sh.cn

    Recruiting

  • The First Affilicated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325003

    Songfu Jiang, 0577-55578023, jiangsongfu@189.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase I Clinical Trial of Human CD19 Targeted T Cells Injection for Subjects With Relapsed and Refractory CD19-positive Diffuse Large B-cell Lymphoma and Follicular Lymphoma

To evaluate the safety and tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive diffuse large B-cell lymphoma and follicular lymphoma. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.

Read the detailed description

Participants with relapsed/refractory CD19-positive Diffuse Large B-cell Lymphoma and Follicular Lymphoma can participate if all eligibility criteria are met.Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI , and blood draws.Participants receive chemotherapy prior to the infusion of CD19 CAR+ T cells. After the infusion, participants will be followed for side effects and effect of CD19 CAR+ T cells. Study procedures may be performed while hospitalized.

Being tested
Human CD19 targeted T Cells Injection
Keywords
CD19, CAR-T, Diffuse Large B-cell Lymphoma, Follicular Lymphoma, Relapsed /Refractory
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular

What participants receive

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

  • Human CD19 targeted T Cells InjectionDrug

    Autologous genetically modified anti-CD19 CAR transduced T cells

Study groups in NCT03720457
Study groupRoleWhat they receive
Human CD19 targeted T Cells InjectionExperimentalNot described
Receives: Drug: Human CD19 targeted T Cells Injection

What is being measured

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

  1. Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0

    Measured: 2 years post infusion

Secondary outcomes (7)

  1. Duration of CAR-positive T cells in circulation

    Measured: 2 years post infusion

  2. Total number of CAR-positive T cells infiltrated into lymphoma tissue

    Measured: 2 years post infusion

  3. Overall remission rate including complete response and Partial response defined by the standard response criteria for malignant lymphoma.

    Measured: 90 days post infusion

  4. Duration of Response after administration

    Measured: 90 days post infusion

  5. Progress Free Survival after administration

    Measured: 90 days post infusion

  6. Overall Survival after administration

    Measured: 90 days post infusion

  7. The immunogenicity of Human CD19 targeted T Cells Injection. (HAMA detection of human anti-mouse antibody)

    Measured: 2 years post infusion

Timeline

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

  1. First posted25 Oct 2018
  2. Study start13 Nov 2018
  3. Primary completionOct 2021 (estimated)
  4. Study completionOct 2023 (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
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03720457
Sponsor's protocol ID
HRAIN01-NHL01
Other IDs
CTR20181354
Status last verified
Aug 2021
First submitted
24 Oct 2018
Last updated
31 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang H, Tsao ST, Gu M, Fu C, He F, Li X, Zhang M, Li N, Hu HM. A simple and effective method to purify and activate T cells for successful generation of chimeric antigen receptor T (CAR-T) cells from patients with high monocyte count. J Transl Med. 2022 Dec 19;20(1):608. doi: 10.1186/s12967-022-03833-6.

    PubMed 36536403

  • Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

    PubMed 34515338

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Human CD19 targeted T Cells Injection in people with CD19-positive and Diffuse Large B-cell Lymphoma, run by Hrain Biotechnology Co., Ltd. at 3 sites 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 16 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 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 Hongliang Fang, Dr. (021-58552006, fanghongliang@dashengbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0 (time frame: 2 years post infusion). 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 NCT03720457, 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 31 Aug 2021.

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