CAR T cell therapy for children with relapsed B-cell leukemia

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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 3 Years to 18 Years
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Tianjin, Tianjin Municipality and 1 other locations)
• Trial ID: NCT06355739 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children aged 3-18 with relapsed or refractory B acute lymphoblastic leukemia or lymphoblastic lymphoma.

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.

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 performed: Other studies using CAR T cell therapy for B-cell malignancies have shown promising results, indicating potential success for this approach.

Eligibility 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 this trial is running

Tianjin, Tianjin Municipality and 1 other locations

• 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)

Conditions B Lymphocytic Leukemia; B Lymphoblastic Lymphoma