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

NCT06355739 | Recruiting

• 1 other identifier: BIC-19GG, BIC-2019,BIC-2219
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

B Lymphocytic Leukemia; B Lymphoblastic Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall remission rate

  One month post CAR-T cell infusion

• Adverse events

  12 months post CAR-T cell infusion

Study Arms (1)

CD19 autotransfusion for B-cell acute lymphoblastic leukemia in children

OTHER

Device: CAR T cell injection

Interventions

CAR T cell injection DEVICE

intravenous injection

CD19 autotransfusion for B-cell acute lymphoblastic leukemia in children

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• , age 3-18 years old (including boundary value), male and female;
• \. 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 (≥
• 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
• \. Lansky score ≥60;
• , the treatment related antigen test result is positive (CD19/CD20/CD22);
• \. The expected survival period from the signing date of the informed consent is more than 3 months;
• , HGB≥70g/L (blood transfusion);

You may not qualify if:

• , severe cardiac insufficiency, left ventricular ejection fraction \<50%;
• , have a history of severe lung function impairment;
• \. Combined with other advanced malignant tumors;
• , combined with serious infection and can not be effectively controlled;
• , combined with serious autoimmune disease or congenital immune deficiency;
• , active hepatitis (hepatitis B virus deoxyribonucleic acid \[HBVDNA\] or hepatitis C virus ribonucleic acid \[HCVRNA\] positive);
• , human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
• \. Have a history of severe allergy to biological products (including antibiotics);
• \. Patients with allogeneic hematopoietic stem cell transplantation still had acute graft-versus-host response (GvHD) one month after immunosuppressant discontinuation;
• , 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.

Sponsors & Collaborators

• Zhu Xiaofan: lead

Study Sites (2)

Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

InstituteHBDH

Tianjin, Tianjin Municipality, 300020, China

NOT YET RECRUITING

MeSH Terms

Conditions

Leukemia, B-Cell; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of department

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: April 9, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)