OncoMatch/Clinical Trials/NCT03676504
Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR
Is NCT03676504 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including CD19.CAR T Cells and Fludarabine for acute lymphoblastic leukemia, adult.
Treatment: CD19.CAR T Cells · Fludarabine · Cyclophosphamide — Adult patients with r/r acute lymphoblastic leukemia (ALL) (stratum I), r/r Non-Hodgkin's lymphoma (NHL) including chronic lymphocytic leukaemia (CLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) or mantle cell lymphoma (MCL) (stratum II) as well as paediatric patients with r/r ALL (stratum III) will be treated with autologous T-lymphocytes transduced by the third-generation RV-SFG.CD19.CD28.4-1BBzeta retroviral vector. The main purpose of this study is to evaluate safety and feasibility of escalating CD19.CAR T cell doses (0,1-20×20\^7 transduced cells/m\^2) after lymphodepletion with fludarabine and cyclophosphamide.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Acute Lymphoblastic Leukemia
Chronic Lymphocytic Leukemia
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 overexpression (confirmed CD19 expression on malignant cells in relapse)
Confirmed CD19+ ALL, CLL, DLBCL, FL or MCL by cytology and flow cytometry (FACS)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: chemoimmunotherapy
Relapsed or refractory disease (including "molecular relapse" with minimal residual disease (MRD) levels > 10^-3 at two occasions > 2 weeks apart) with confirmed CD19 expression on malignant cells in relapse
Must have received: Bruton's tyrosine kinase inhibitor — CLL
failure or intolerance of both Bruton's tyrosine kinase Inhibitor (BTKi) and B-cell lymphoma 2 inhibitors (BCL-2i)
Must have received: B-cell lymphoma 2 inhibitor — CLL
failure or intolerance of both Bruton's tyrosine kinase Inhibitor (BTKi) and B-cell lymphoma 2 inhibitors (BCL-2i)
Must have received: autologous stem cell transplantation — DLBCL, FL, MCL
Relapse after autologous stem cell transplantation (autoSCT)
Must have received: allogeneic stem cell transplantation — ALL, CLL, DLBCL, FL, MCL
Any relapse after allogeneic stem cell transplantation (alloSCT) (≥ 6 months from alloSCT at time of CAR T cell infusion)
Must have received: idelalisib — FL
ineligibility for or failure of idelalisib
Lab requirements
Blood counts
ANC ≥ 500/mm3; ALC ≥ 100/mm3
Kidney function
serum creatinine of ≤ 2 x ULN or eGFR ≥ 30 mL/min/1.73 m^2 (adults); serum creatinine-clearance ≥ 30 mL/min/1.73 m^2 (children)
Liver function
ALT ≤ 5 times the ULN for the respective age; Bilirubin ≤ 2.0 mg/dl (exceptions for Gilbert-Meulengracht syndrome or extrahepatic disease)
Cardiac function
Hemodynamic stability and LVEF ≥ 40% (adults); LVEF ≥ 40% or shortening fraction > 29% (children)
Adequate organ function: Renal function defined as: serum creatinine of ≤ 2 x ULN or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m^2; Liver function defined as: ALT ≤ 5 times the ULN for the respective age; Bilirubin ≤ 2.0 mg/dl with the exception of patients with hyperbilirubinemia explained by Gilbert-Meulengracht syndrome (may be included if total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) or extrahepatic disease (e.g. chronic hemolytic anemia); minimum level of pulmonary reserve defined as ≤ grade 1 dyspnea and pulse oxygenation > 90% on room air; Hemodynamic stability and left ventricular ejection fraction (LVEF) ≥ 40% as confirmed by echocardiogram; Absolute neutrophil count (ANC) ≥ 500/mm3; Absolute lymphocyte count (ALC) ≥ 100/mm3
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT03676504 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received chemoimmunotherapy and Bruton's tyrosine kinase inhibitor.
Does this trial require CD19?
Yes, CD19 overexpression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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