Clinical Trials /

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

NCT04213469

Description:

This is a non-randomized, open label, single-site, dose-escalation study in up to 18 participants with relapse/refractory B-cell lymphoma. This study aims to evaluate the safety and efficacy of the treatment with Quikin CD19-CART.

Related Conditions:
  • Non-Hodgkin Lymphoma
Recruiting Status:

Not yet recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Quikin CD19-CART in Patients With r/r B-cell Lymphoma
  • Official Title: a Safety and Efficacy Evaluation of Quikin CD19-CART in Patients With Relapse/Refractory B-cell Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: 2019-CAR-00CH2
  • NCT ID: NCT04213469

Conditions

  • B-cell Lymphoma

Interventions

DrugSynonymsArms
CD19-Specific Chimeric Antigen Receptor T cells with PD1 knockoutQuikin-CD19-CART, PD1-targeting integrated CD19-CARTQuikin CD19-CART

Purpose

This is a non-randomized, open label, single-site, dose-escalation study in up to 18 participants with relapse/refractory B-cell lymphoma. This study aims to evaluate the safety and efficacy of the treatment with Quikin CD19-CART.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Quikin CD19-CARTExperimentalPatients 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.
  • CD19-Specific Chimeric Antigen Receptor T cells with PD1 knockout

Eligibility Criteria

        Inclusion Criteria:

          1. Have the capacity to give informed consent;

          2. ALL patients with the age between 18 and 65;

          3. Expected survival >3 moths;

          4. With no severe heart and lung disease;

          5. Previously confirmed diagnosis as CD19+ 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.
      
Maximum Eligible Age:65 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose-limiting toxicity (DLT)
Time Frame:up to 28 days after T cell infusion
Safety Issue:
Description:Incidence of toxicity graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Secondary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:Baseline up to 3 months after T cell infusion
Safety Issue:
Description:Proportion of patients in whom a response among complete response and partial response as defined by standard disease-specific criteria, will be observed.
Measure:Progress free survival (PFS)
Time Frame:3 months
Safety Issue:
Description:Assessed using modified Lugano classification response criteria for lymphoma (2014) Inclusion criteria Inclusion criteria

Details

Phase:N/A
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Shanghai Bioray Laboratory Inc.

Last Updated

December 26, 2019