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Status unknownNCT03720457Updated Aug 31, 2021

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

A Phase 1 interventional study of Human CD19 targeted T Cells Injection in CD19-positive, Diffuse Large B-cell Lymphoma and Follicular Lymphoma, sponsored by Hrain Biotechnology Co., Ltd.. Status unknown at 3 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-08-31.

Sponsored by Hrain Biotechnology Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • CD19-positive
  • Diffuse Large B-cell Lymphoma
  • Follicular Lymphoma

Keywords

  • CD19
  • CAR-T
  • Diffuse Large B-cell Lymphoma
  • Follicular Lymphoma
  • Relapsed /Refractory
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 18 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Hrain Biotechnology Co., Ltd. is the lead sponsor of 14 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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.

  1. 18 to 70 Years Old, Male and female;
  2. Expected survival > 12 weeks;
  3. Clinical performance status of ECOG score 0-1;
  4. Pathology demonstrated that CD19-positive B-cell non-Hodgkin's lymphoma and who meet one of the following conditions:

    1. 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;
    2. Disease recurrence after stem cell transplantation, and at least 1 years after stem cell transplantation.
  5. 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;
  6. At least 1 measurable tumor foci according to the 2014 Lugano treatment response criteria;
  7. Liver, kidney and cardiopulmonary functions meet the following requirements:

    1. Serum creatinine ≤ 1.5 × ULN;
    2. Left ventricular ejection fraction >50%, no pericardial effusion and no pleural effusion (ECHO examination);
    3. Baseline oxygen saturation > 92%;
    4. Total bilirubin ≤ 1.5 × ULN;
    5. ALT and AST ≤ 3 × ULN.
  8. Able to understand and sign the Informed Consent Document.

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. 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;
  3. 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;
  4. Any other diseases could affect the outcome of this trial;
  5. Any affairs could affect the safety of the subjects or outcome of this trial;
  6. 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;
  7. Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
  8. 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;
  9. Received CAR-T treatment or other gene therapies before enrollment;
  10. 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;
  11. Subject suffering disease affects the understanding of informed consent or comply with study protocol;
  12. The investigators consider other conditions unsuitable for enrollment.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    Human CD19 targeted T Cells Injection

    Drug: Human CD19 targeted T Cells Injection

Interventions

  • DrugHuman CD19 targeted T Cells Injection

    Autologous genetically modified anti-CD19 CAR transduced T cells

06

What researchers measure

Primary outcomes

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

    Time frame: 2 years post infusion

Secondary outcomes

  1. Duration of CAR-positive T cells in circulation

    Time frame: 2 years post infusion

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

    Time frame: 2 years post infusion

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

    Time frame: 90 days post infusion

  4. Duration of Response after administration

    Time frame: 90 days post infusion

  5. Progress Free Survival after administration

    Time frame: 90 days post infusion

  6. Overall Survival after administration

    Time frame: 90 days post infusion

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

    Time frame: 2 years post infusion

07

Study locations

3 of 3 sites recruiting
  • The Second Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi 330006, China
    Recruiting
  • Fudan University Zhongshan Hospital
    Shanghai, Shanghai 200000, China
    Recruiting
  • The First Affilicated Hospital of Wenzhou Medical University
    Wenzhou, Zhejiang 325003, China
    Recruiting
08

References and documents

Publications

  • 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03720457
Lead sponsor
Hrain Biotechnology Co., Ltd.
Collaborators
Shanghai Zhongshan Hospital
Responsible party
Sponsor
First posted
Oct 25, 2018
Start date
Nov 13, 2018
Primary completion
Oct 2021 (estimated)
Completion
Oct 2023 (estimated)
Last update
Aug 31, 2021

Study contacts

Hongliang Fang, Dr.
Contact
fanghongliang@dashengbio.com
021-58552006

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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