Clinical Trials /

CD19-CAR-T in B-cell Malignancies Patients

NCT03952923

Description:

This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of CD19-CAR-T cells in patients with refractory and relapsed B-cell malignancies.

Related Conditions:
  • B-Cell Acute Lymphoblastic Leukemia
  • B-Cell Non-Hodgkin Lymphoma
  • Classical Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: CD19-CAR-T in B-cell Malignancies Patients
  • Official Title: CD19-CAR-T for Patients With B Cell Malignancies

Clinical Trial IDs

  • ORG STUDY ID: LDP-C-001
  • NCT ID: NCT03952923

Conditions

  • B-cell Malignancy

Interventions

DrugSynonymsArms
CD19-CAR-T cellsCD19-CAR-T cells

Purpose

This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of CD19-CAR-T cells in patients with refractory and relapsed B-cell malignancies.

Detailed Description

      This Phase I study is designed as a pilot trial evaluating the safety and of CD19-CAR-T cell
      therapy in subjects with refractory and relapsed B cell malignancies. Subjects will receive
      cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3
      followed by infusion of CD19-CAR-T cells. Safety and efficacy of CD19-CAR-T cells therapy
      will be monitored. The purpose of current study is to determine the clinical efficacy and
      safety of CD19-CAR-T cells therapy in patients with refractory and relapsed B-cell
      malignancies.
    

Trial Arms

NameTypeDescriptionInterventions
CD19-CAR-T cellsExperimentalCD19-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.
  • CD19-CAR-T cells

Eligibility Criteria

        Inclusion Criteria:

          1. Relapsed and refractory CD19 positive B-cell acute malignancies with:

               -  Relapsed after competed remission, could not get competed remission after at more
                  than 1 course of chemotherapy (including MRD≥0.1%);

               -  MRD≥0.1% after allogeneic hematopoietic stem cell transplantation(HSCT), or
                  recurrence after complete remission or MRD ≥ 0.1% after HSCT;

               -  Refractory: at least two courses of chemotherapy did not achieve complete
                  remission or MRD ≥ 0.1%;

          2. Patients must have evaluable evidence of disease, including minimal residual disease
             (MRD);

          3. Ph + patients who meet the following criteria can register:Failure to tolerate TKI or
             TKI treatment failure, or failure to transplant;

          4. Ages 1 to 70 years, including boundary values;

          5. ECOG score 0-3 points;

          6. Women of childbearing age (15-49 years old) must receive a pregnancy test within 7
             days prior to initiation of treatment and the results are negative; male and female
             patients with fertility must use an effective contraceptive to ensure 3 months after
             discontinuation of treatment during the study period not pregnant inside.

        Exclusion Criteria:

          1. patients with organ failure:

               -  Heart: NYHA heart function grade IV;

               -  Liver: Grade C that achieves Child-Turcotte liver function grading;

               -  Kidney: kidney failure and uremia;

               -  Lung: symptoms of respiratory failure;

               -  Brain: a person with a disability;

          2. Active infections that are difficult to control;

          3. Human immunodeficiency virus (HIV) positive;

          4. Liver and kidney function: total bilirubin > 5 × ULN, aspartate aminotransferase (AST)
             and alanine aminotransferase (ALT) > 5 × ULN, serum creatinine clearance rate 60mL /
             min;

          5. GVHD ≥ 2 or anti-GVHD treatment;

          6. Received allogeneic cell therapy within 4 weeks, such as donor lymphocyte infusion;

          7. Subject received anti-tumor treatment (chemotherapy, mAb, or hormone) for less than 1
             week;

          8. Central nervous system white blood that is symptomatic or uncontrolled by systemic
             chemotherapy and intrathecal chemotherapy (a large number of tumor cells in CSF, white
             blood cell count >15WBCs/mL);

          9. intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular
             internal coagulation;

         10. pregnant or lactating women;

         11. The patient does not agree to use effective contraception during the treatment period
             and for the next 3 months;

         12. Patients who participate in other clinical studies at the same time;

         13. The investigator believes that there are other factors that are not suitable for
             inclusion or influence the subject's participation or completion of the study.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:1 Year
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Percentage of adverse events
Time Frame:6 months
Safety Issue:
Description:Percentage of participants with adverse events.

Secondary Outcome Measures

Measure:Relapse-Free Survival(RFS )
Time Frame:6 months
Safety Issue:
Description:
Measure:Overall-Survival(OS)
Time Frame:6 months
Safety Issue:
Description:
Measure:Persistence of CAR-T cells in vivo
Time Frame:6 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Hebei Yanda Ludaopei Hospital

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