CAR T cell therapy for children with relapsed B-cell leukemia
Official title: 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
Run by Institute of Hematology & Blood Diseases Hospital, China · NCT06355739 · Data updated 2026-11-12
This study is testing a new CAR T cell therapy to see if it can help children aged 3 to 18 with relapsed or hard-to-treat B-cell leukemia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 18 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Tianjin, Tianjin Municipality and 1 other locations) |
| Status | Recruiting |
| Started | February 1, 2024 |
| Main results expected | December 1, 2026 |
| Study ends | January 15, 2027 |
| Registry record updated | April 9, 2024 |
| Trial ID | NCT06355739 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 3-18 with relapsed or refractory B acute lymphoblastic leukemia or lymphoblastic lymphoma.
✕Probably not a fit
Patients who do not have CD19+ tumors or have not been diagnosed with relapsed or refractory B-cell leukemia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the safety and efficacy of a CAR T cell therapy, specifically BIC-19GG, BIC-2019, and BIC-2219, for treating children aged 3 to 18 with relapsed or refractory B acute lymphoblastic leukemia or lymphoblastic lymphoma. The approach involves autotransfusion of genetically modified T cells that target the CD19 antigen on cancer cells. Patients eligible for the trial must have not responded to standard chemotherapy or have experienced recurrence of their disease. The study aims to provide a new treatment option for this challenging pediatric population.
Why it matters
Potential benefit: If successful, this therapy could offer a new hope for children with difficult-to-treat B-cell leukemia.
How similar studies have gone: Other studies using CAR T cell therapy for B-cell malignancies have shown promising results, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Department of Pediatrics, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China Recruiting -
InstituteHBDH
Tianjin, Tianjin Municipality, China Not yet recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.