Clinical Trials /

Anti-CD19 U-CAR-T Cell Therapy for B Cell Hematologic Malignancies

NCT04264039

Description:

The stunning response rate of anti-CD19(cluster of differentiation antigen 19) auto-CAR(chimeric antigen receptor)-T cell therapy brings hope to patients with relapsed or refractory B-cell hematologic malignancies. However, based on open clinical trials, using patients' T cells might encounter the failure of apheresis available T cells, even if successful, the time needed for the manufacture could also cause the irreversible disease progress. Furthermore, the cost of auto-CAR-T cells is not affordable for most patients. So to provide an accessible and affordable anti-CD19 CAR-T cell therapy for patients with B-cell hematologic malignancies, we launch such a trial that using the edited T cells from healthy donors to manufacture universal CAR-T cells and adapt it in patients with CD19+ B-cell leukemia or lymphoma.

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

Not yet recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Anti-CD19 U-CAR-T Cell Therapy for B Cell Hematologic Malignancies
  • Official Title: Anti-CD19 Universal CAR-T Cells for CD19+ B Cell Hematologic Malignancies: a Multi-center, Uncontrolled Trial

Clinical Trial IDs

  • ORG STUDY ID: antiCD19-UCAR-T
  • NCT ID: NCT04264039

Conditions

  • B-cell Acute Lymphoblastic Leukemia
  • B-cell Lymphoma

Interventions

DrugSynonymsArms
anti-CD19 UCAR-T cellsanti-CD19 UCAR-T cells
Fludarabineanti-CD19 UCAR-T cells
Cytoxananti-CD19 UCAR-T cells
Melphalananti-CD19 UCAR-T cells

Purpose

The stunning response rate of anti-CD19(cluster of differentiation antigen 19) auto-CAR(chimeric antigen receptor)-T cell therapy brings hope to patients with relapsed or refractory B-cell hematologic malignancies. However, based on open clinical trials, using patients' T cells might encounter the failure of apheresis available T cells, even if successful, the time needed for the manufacture could also cause the irreversible disease progress. Furthermore, the cost of auto-CAR-T cells is not affordable for most patients. So to provide an accessible and affordable anti-CD19 CAR-T cell therapy for patients with B-cell hematologic malignancies, we launch such a trial that using the edited T cells from healthy donors to manufacture universal CAR-T cells and adapt it in patients with CD19+ B-cell leukemia or lymphoma.

Trial Arms

NameTypeDescriptionInterventions
anti-CD19 UCAR-T cellsExperimentalAfter preconditioning with chemotherapy ( Fludarabine, Cytoxan and/or Melphalan), the dosage of anti-CD19 UCAR-T cells between 1 and 5 ×10^7 cells/Kg will be evaluated
  • anti-CD19 UCAR-T cells
  • Fludarabine
  • Cytoxan
  • Melphalan

Eligibility Criteria

        Inclusion Criteria:

          -  1. Diagnosis of recurrent B-cell acute lymphoblastic leukemia (B-ALL), B-cell acute
             lymphoblastic lymphoma (B-LLy), or B-non-Hodgkin lymphoma (B-NHL)

             2. CD19-positive tumor (≥20% CD19 positive blasts by flow cytometry or
             immunohistochemistry (tissue))

             3. Hgb ≥ 7.0 (can be transfused)

             4. Life expectancy greater than 12 weeks

             5. Informed consent explained to, understood by and signed by the patient/guardian.
             The patient/guardian is given a copy of informed consent.

        Exclusion Criteria:

          1. Pregnant or lactating.

          2. Tumor in a location where enlargement could cause airway obstruction (per investigator
             discretion).

          3. Active infection with HIV or HTLV.

          4. Clinically significant viral infection or uncontrolled viral reactivation of
             EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BK-virus, or HHV(human
             herpesvirus)-6.

          5. Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial
             infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT,
             per investigator discretion. Cardiac echocardiography with LVSF (left ventricular
             shortening fraction)<30% or LVEF(left ventricular ejection fraction)<50%; or
             clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart
             Association) III or IV (Confirmation of absence of these conditions on echocardiogram
             within 12 months of treatment).

          6. CNS abnormalities: Presence of CNS(central nervous system)-3 disease defined as
             detectable cerebrospinal blast cells in a sample of CSF(cerebrospinal fluid) with ≥ 5
             WBC( white blood cell)s per mm3 (unless negative by the Steinherz/Bleyer algorithm);
             Presence of any CNS disorder such as an uncontrolled seizure disorder, cerebrovascular
             ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS
             involvement.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:2 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:the anti-tumor efficiency of anti-CD19 UCAR-T cells
Time Frame:4 weeks after infusion
Safety Issue:
Description:ratio of bone marrow blast cells and/or the measurable lesion size and strandralized uptake value

Secondary Outcome Measures

Measure:the long-term efficiency of anti-CD19 UCAR-T cells
Time Frame:3 and 6 months after infusion
Safety Issue:
Description:ratio of bone marrow blast cells and/or the measurable lesion size and strandralized uptake value

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Xinqiao Hospital of Chongqing

Last Updated

February 7, 2020