Human CD19 Targeted T Cells Injection(CD19 CAR-T) Therapy for Relapsed and Refractory CD19-positive Lymphoma.
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
2 other identifiers
interventional
18
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2018
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2018
CompletedFirst Posted
Study publicly available on registry
October 25, 2018
CompletedStudy Start
First participant enrolled
November 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedAugust 31, 2021
August 1, 2021
2.9 years
October 24, 2018
August 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0
2 years post infusion
Secondary Outcomes (7)
Duration of CAR-positive T cells in circulation
2 years post infusion
Total number of CAR-positive T cells infiltrated into lymphoma tissue
2 years post infusion
Overall remission rate including complete response and Partial response defined by the standard response criteria for malignant lymphoma.
90 days post infusion
Duration of Response after administration
90 days post infusion
Progress Free Survival after administration
90 days post infusion
- +2 more secondary outcomes
Study Arms (1)
Human CD19 targeted T Cells Injection
EXPERIMENTALInterventions
Autologous genetically modified anti-CD19 CAR transduced T cells
Eligibility Criteria
You may qualify if:
- 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.
- 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;
- 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.
- +1 more criteria
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hrain Biotechnology Co., Ltd.lead
- Shanghai Zhongshan Hospitalcollaborator
Study Sites (3)
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, 200000, China
The First Affilicated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325003, China
Related Publications (2)
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.
PMID: 36536403DERIVEDErnst 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.
PMID: 34515338DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2018
First Posted
October 25, 2018
Study Start
November 13, 2018
Primary Completion
October 1, 2021
Study Completion
October 1, 2023
Last Updated
August 31, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share