OncoMatch/Clinical Trials/NCT07361029
CD19 Chimeric Antigen Receptor (CAR) T Cells in Adults With Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia
Is NCT07361029 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies non-drug interventions for relapsed refractory acute lymphoblastic leukemia.
This is a Phase Ia, open label, dose finding single center trial designed to evaluate the maximum tolerated dose, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of CD19 CAR T cells targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in adults (age 18 - 75) with relapsed/refractory acute lymphoblastic leukemia (ALL).
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 positive expression
documentation of CD19 tumor expression in BM or peripheral blood by flow cytometry or immunohistochemistry within 1 month of study entry
Demographics
Prior therapy
Must have received: chemotherapy — refractory or relapsed
Primary refractory, defined as not achieving complete remission (CR) after 2 cycles of a standard chemotherapy regimen, or Chemo-refractory, defined as not achieving CR after 1 cycle of standard chemotherapy for relapsed leukemia
Must have received: tyrosine kinase inhibitor — Philadelphia chromosome-positive ALL
Philadelphia chromosome-positive ALL intolerant of or with 2 failed lines of tyrosine kinase inhibitor (TKI) therapy
Must have received: allogeneic stem cell transplant — relapsed after AlloSCT
Relapsed after AlloSCT. at least 12 weeks after alloSCT or relapse happened after withdrawing the post-transplant immunosuppression
Must have received: CAR-T cell therapy — relapsed after prior CAR T cell and still CD19 positive
Relapsed after prior CAR T cell and still CD19 positive
Cannot have received: gene therapy
Exception: except prior CAR-T cell therapy
Treatment with any prior gene therapy product (except prior CAR-T cell therapy)
Cannot have received: autologous transplant
Autologous transplant within 6 weeks of planned CAR-T cell infusion
Lab requirements
Blood counts
ANC ≥ 1.0 x 10^9/L without growth factors; Platelet count ≥ 50 x 10^9/L without transfusion support within 7 days of screening; Absolute lymphocyte count ≥ 0.5 x 10^9/L
Kidney function
Creatinine clearance ≥ 60 cc/min; GFR > 60mL/min
Liver function
ALT ≤5x ULN; AST/ALT ≤ 5 x ULN and bilirubin ≤ 2 x ULN. Total bilirubin 1.5 ULN (except Gilbert's syndrome)
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram or MUGA scan and QTcF ≤ 480 ms
Alanine aminotransferase (ALT) ≤5 times the upper limit of normal for age; Bilirubin ≤2 x ULN; Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 cc/min; Glomerular Filtration Rate (GFR) > 60mL/min; AST/ALT ≤ 5 x ULN and bilirubin ≤ 2 x ULN. Total bilirubin 1.5 ULN (except Gilbert's syndrome); ANC ≥ 1.0 x 10^9/L without the use of growth factors; Platelet count ≥ 50 x 10^9/L without transfusion support within 7 days of screening; Absolute lymphocyte count ≥ 0.5 x 10^9/L; Left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram or MUGA scan and QTcF ≤ 480 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07361029 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior gene therapy, autologous transplant disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 positive expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 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 qualifyRelated pages