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

Phase II Clinical Study on the Safety and Efficacy of Autotransfusion Agents Targeting CD19 Chimeric Antigen Receptor T Lymphocytes (BIC-19GG, BIC-2019,BIC-2219)in the Treatment of CD19-positive Children With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma

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

Study Overview

• Status: Recruiting
• Conditions: B Lymphoblastic Lymphoma; B Lymphocytic Leukemia
• Intervention / Treatment: Device: CAR T cell injection

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300020
      • Recruiting
      • Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
      • Contact: Xiaofan Zhu, MD; Phone Number: 86-21-23909001; Email: xfzhu@ihcams.ac.cn
      • Sub-Investigator: Jingliao Zhang, MD
    • Tianjin, Tianjin, China, 300020
      • Not yet recruiting
      • InstituteHBDH
      • Contact: Zhu Xiaofan; Phone Number: 86-21-23909001; Email: xfzhu@ihcams.ac.cn
      • Principal Investigator: Guo Ye
      • Principal Investigator: Yang Wenyu
      • Principal Investigator: Chen Xiaojuan
      • Principal Investigator: Chen Yumei
      • Principal Investigator: Ruan Min

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1, age 3-18 years old (including boundary value), male and female;

2. The patient was clinically diagnosed as relapsed/refractory B acute lymphoblastic leukemia/lymphoblastic lymphoblastic

Patients with tumors who meet one of the following conditions:

• Complete marrow response (MRD>1%) or not achieved after at least 2 courses of standardized induction regimen chemotherapy

Complete response at the molecular level and immunology (characterized by specific molecular markers and immunophenotypes prior to treatment)

Patients, did not turn negative after treatment);

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

  12 months) and did not achieve complete remission after 1 course of standard induction regimen (MRD>1%);

• Recurrence after bone marrow transplantation;
• Simple bone marrow, simple extramedullary (testicular leukemia, central nervous system leukemia) or combined

recrudescence

3. Lansky score ≥60;

4, the treatment related antigen test result is positive (CD19/CD20/CD22);

5. The expected survival period from the signing date of the informed consent is more than 3 months;

6, HGB≥70g/L (blood transfusion);

7, liver and kidney function, cardiopulmonary function meet the following requirements:

1. Creatinine ≤1.5×ULN;
2. Left ventricular ejection fraction ≥50%;
3. Blood oxygen saturation >90%;

4. Total bilirubin ≤1.5×ULN; ALT and AST≤2.5 x ULN.-

   Exclusion Criteria:

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

     2, have a history of severe lung function impairment;

     3. Combined with other advanced malignant tumors;

     4, combined with serious infection and can not be effectively controlled;

     5, combined with serious autoimmune disease or congenital immune deficiency;

     6, active hepatitis (hepatitis B virus deoxyribonucleic acid [HBVDNA] or hepatitis C virus ribonucleic acid [HCVRNA] positive);

     7, human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;

     8. Have a history of severe allergy to biological products (including antibiotics);

     9. Patients with allogeneic hematopoietic stem cell transplantation still had acute graft-versus-host response (GvHD) one month after immunosuppressant discontinuation;

     10, the presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participating in the study or interfere with the study results, as well as patients deemed unsuitable for participation in the study by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CD19 autotransfusion for B-cell acute lymphoblastic leukemia in children	Device: CAR T cell injection; intravenous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival and event-free survival	The prognosis of ALL children who underwent CAR-T cell therapy	24 months post CAR-T cell infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall remission rate	The ORR of ALL children who underwent CAR-T cell therapy	One month post CAR-T cell infusion
Adverse events	Incidence of adverse events and its severity	12 months post CAR-T cell infusion

Collaborators and Investigators

• Sponsor: Zhu Xiaofan

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 15, 2027

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Hematologic Diseases; Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia, B-Cell
• Other Study ID Numbers: BIC-19GG, BIC-2019,BIC-2219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No