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Quikin CD19-CART in Patients With r/r B-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04213469
Recruitment Status : Recruiting
First Posted : December 30, 2019
Last Update Posted : March 16, 2020
Sponsor:
Collaborator:
Second Xiangya Hospital of Central South University
Information provided by (Responsible Party):
Shanghai Bioray Laboratory Inc.

Brief Summary:
This is a non-randomized, open label, single-site, dose-escalation study in up to 50 participants with relapse/refractory B-ALL and NHL. This study aims to evaluate the safety and efficacy of the treatment with Quikin CD19-CART.

Condition or disease Intervention/treatment Phase
B-cell Lymphoma Biological: CD19-Specific Chimeric Antigen Receptor T cells with PD1 knockout Not Applicable

Detailed Description:
Quikin CD19-CART is a kind of chimeric antigen T cell targeting CD19 with both CD19-CAR gene integration and also PD1 knockout by one-step gene-editing. After completion of study treatment, subject participation for this study will be followed up to 15 years after completion of study treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Patients will receive one of the three doses of 3*10^5/kg, 6*10^5/kg,10*10^5/kg.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: a Safety and Efficacy Evaluation of Quikin CD19-CART in Patients With Relapse/Refractory B-cell Lymphoma
Actual Study Start Date : March 13, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Quikin CD19-CART
Patients undergo leukapheresis. Patients will receive a lymphodepletion chemotherapy with cyclophosphamide and fludarabine 4-6 days before CART infusion. A dose of Quikin CD19-CART will be infused on day 0.
Biological: CD19-Specific Chimeric Antigen Receptor T cells with PD1 knockout
Autologous CD4+ and CD8+ T cells by gene-editing with both knockout of PD1 and also integration of anti-CD19 ScFv
Other Names:
  • Quikin-CD19-CART
  • PD1-targeting integrated CD19-CART




Primary Outcome Measures :
  1. Dose-limiting toxicity (DLT) [ Time Frame: up to 28 days after T cell infusion ]
    Incidence of toxicity graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Baseline up to 3 months after T cell infusion ]
    Proportion of patients in whom a response among complete response and partial response as defined by standard disease-specific criteria, will be observed.

  2. Progress free survival (PFS) [ Time Frame: 3 months ]
    Assessed using modified Lugano classification response criteria for lymphoma (2014) and NCCN clinical practice guidelines in oncology acute Acute Lymphoblastic Leukemia(2018)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have the capacity to give informed consent;
  2. ALL patients with the age between 5 and 70;
  3. Expected survival >3 moths;
  4. With no severe heart and lung disease;
  5. Previously confirmed diagnosis as CD19+ B-ALL or NHL within 6 months;
  6. Hematological index as following, white blood cell (WBC)≥1.5×10^9/L,absolute neutrophil count (ANC) ≥0.8×10^9/L, Platelet count≥50×109/L, Hemoglobin (Hgb) ≥ 90mg/L, lymphocyte count≥ 0.4×10^9/L;
  7. Blood biochemical index as no more than 1.5* ULN, including total bilirubin (TBIL), transglutaminase (AST), alanine aminotransferase (AST), Creatinine (SCr), Urea in patients with no tumor metastasis in liver and kidney; Blood biochemical index no more than 5* ULN in patients with tumor metastasis in liver and kidney;
  8. With a stable cardiac function, the left ventricular ejection fraction (LVEF) ≥ 55%;
  9. Virological tests were negative for EBV, CMV, HIV, TP and HCV;
  10. ECOG <2;
  11. Relapsed or refractory (r/r) NHL including, Diffuse large B cell lymphoma(DLBCL, NOS), stage Ⅲ-Ⅳ;Primary mediastinal large B-cell lymphoma (PMBL), stage Ⅲ-Ⅳ; High grade B-cell lymphoma (HGBL), stage Ⅲ-Ⅳ; Mantle cell lymphoma (MCL), stage Ⅲ-Ⅳ; follicular lymphoma (FL), stage Ⅲ-Ⅳ and with aggression. r/r NHL defined as following, demonstrate disease that persists or relapse after achieving complete response (CR) after > 2 cycles of standard chemotherapy, or relapse after autologous hematopoietic stem cell transplantation (auto-HSCT), or not achieving CR after auto-HSCT.

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. With a pregnancy plan in the next 2 years;
  3. Prior treatment of anti-GVHD therapy;
  4. Acceptance of allogeneic stem cell transplant (ASCT);
  5. Isolated extramedullary relapse of ALL;
  6. Severe mental disorders, active autoimmune diseases, active infectious diseases, severe cardiovascular diseases;
  7. Partial prothrombin time or activated partial thromboplastin time or international standardized ratio > 1.5*ULN without anticoagulant treatment;
  8. History of other type of maligant tumors;
  9. Any circumstances that possibly increase the risk of subjects or interfere with study results, which judged by investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04213469


Contacts
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Contact: Wei Li, MD +862164340008 wli@bioraylab.com

Locations
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China, Zhejiang
the First Affliated Hospital, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Yongxian Hu, Prof    +8615957162012      
Sponsors and Collaborators
Shanghai Bioray Laboratory Inc.
Second Xiangya Hospital of Central South University
Investigators
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Principal Investigator: He Huang, Prof the First Affliated Hospital, Zhejiang University
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Responsible Party: Shanghai Bioray Laboratory Inc.
ClinicalTrials.gov Identifier: NCT04213469    
Other Study ID Numbers: 2019-CAR-00CH2
First Posted: December 30, 2019    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin