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CD19-targeted CAR T Cell Autotransfusion for the Treatment of Recurrent/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma in Children With CD19+

ConditionsB Lymphocytic LeukemiaB Lymphoblastic Lymphoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorZhu Xiaofan

About this trial

To evaluate the safety and efficacy of BIC-19GG, BIC-2019, BIC-2219 in the treatment of relapsed/refractory B acute lymphoblastic leukemia/lymphoblastic lymphoma in children

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Recurrence during chemotherapy, early recurrence after drug withdrawal (<12 months) or late recurrence after complete remission (≥

Recurrence after bone marrow transplantation;

Simple bone marrow, simple extramedullary (testicular leukemia, central nervous system leukemia) or combined

Creatinine ≤1.5×ULN;

Disqualifiers

1, severe cardiac insufficiency, left ventricular ejection fraction <50%;

Trial design

Design model

Single group

Treatments tested in this trial

  • CAR T cell injection

    Device

    intravenous injection

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: CD19 autotransfusion for B-cell acute lymphoblastic leukemia in childrenOther 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival and event-free survival

The prognosis of ALL children who underwent CAR-T cell therapy

Time frame
24 months post CAR-T cell infusion

Secondary outcomes

1

Overall remission rate

The ORR of ALL children who underwent CAR-T cell therapy

Time frame
One month post CAR-T cell infusion
2

Adverse events

Incidence of adverse events and its severity

Time frame
12 months post CAR-T cell infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhu Xiaofan

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Sponsor institution

Source ClinicalTrials.gov
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