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New treatment option for B Lymphocytic Leukemia
Official title CD19-targeted CAR T Cell Autotransfusion for the Treatment of Recurrent/Refractory B-cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma in Children With CD19+
ClinicalTrials.gov ID: NCT06355739
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 18
You may be able to join if
- 1, age 3-18 years old (including boundary value), male and female; 2\. The patient was clinically diagnosed as relapsed/refractory B acute...
- Complete marrow response (MRD\>1%) or not achieved after at least 2 courses of standardized induction regimen chemotherapy Complete response at the...
- Recurrence during chemotherapy, early recurrence after drug withdrawal (\ 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...
You likely can't join if
- 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);
See the full eligibility 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...
- 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...
- Recurrence during chemotherapy, early recurrence after drug withdrawal (\ 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)...
- Creatinine ≤1.5×ULN;
- Left ventricular ejection fraction ≥50%;
- Blood oxygen saturation \>90%;
- Total bilirubin ≤1.5×ULN; ALT and AST≤2.5 x ULN.-
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.