OncoMatch/Clinical Trials/NCT06709469
Phase I Clinical Trial of CART Cell Therapy for Refractory/Relapsed Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults
Is NCT06709469 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Autologous CD19/CD22 CAR T cells and Allogeneic CART-NKG2D cells for precursor cell lymphoblastic leukemia-lymphoma.
Treatment: Autologous CD19/CD22 CAR T cells · Allogeneic CART-NKG2D cells — The goal of this clinical trial is to test the feasibility and safety of an academic production of two different anti-CD19 chimeric antigen receptor T cells (CART) products according to the different biomarkers of the disease in children and young adults with relapsed/refractory CD19+ B cell acute lymphoblastic leukemia (r/r B-ALL) or relapsed/refractory T-cell acute lymphoblastic leukemia (r/r T-ALL). The main questions it aims to answer are: 1. The safety and feasibility of autologous CART-19/22 in children, adolescents and young adults with a CD19+/- CD22+ relapse/ refractory disease for a r/r B-ALL. 2. The safety and feasibility of allogeneic CART-NKG2D (chimeric-antigen receptor Natural-killer group 2, member D) in children, adolescents and young adults with r/r T-ALL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive or negative
CD19+/- CD22+ B-ALL
Required: CD22 positive
CD19+/- CD22+ B-ALL
Prior therapy
Must have received: conventional chemotherapy
relapsed or refractory disease not responding to conventional chemotherapy
Lab requirements
Blood counts
ANC ≥ 500/μL unless cytopenia due to leukemia; Platelet count ≥ 50,000/μL unless cytopenia due to leukemia; Absolute lymphocyte count ≥ 100/μL
Kidney function
GFR ≥ 30 ml/min
Liver function
bilirubin ≤ 3 times the upper limit of normality (unless due to Gilbert's syndrome)
Cardiac function
LVSF ≥ 30% and LVEF ≥ 40%; no clinically significant pericardial effusion
Adequate renal, hepatic, pulmonary, and cardiac function. Cardiac echocardiography with LVSF<30% or LVEF<40%; or clinically significant pericardial effusion [excluded]. GFR <30 ml/min or bilirubin >3 times the upper limit of normality (unless due to Gilbert's syndrome) [excluded]. ANC ≥ 500/μL unless...cytopenia is due to underlying leukemia...Platelet count ≥ 50,000/μL unless...cytopenia is due to underlying leukemia...Absolute lymphocyte count ≥ 100/μL.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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