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 (Jun 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
Treatments studied
Other
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
Demographics
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.
Frequently asked questions
Is NCT06709469 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received conventional chemotherapy.
Does this trial require CD19?
Yes, CD19 positive or negative is a required biomarker for enrollment.
Does this trial require CD22?
Yes, CD22 positive is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 30 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify