OncoMatch/Clinical Trials/NCT05702853
Metabolically Fit CD19 CAR T-cell Therapy With CD34 Selection in Patients With CD19+ Relapsed/Refractory NHL, CLL/SLL
Is NCT05702853 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including CD19-CD34t metabolically programmed CAR transduced T-cells and Cyclophosphamide for b-cell non hodgkin lymphoma.
Treatment: Cyclophosphamide · Fludarabine · CD19-CD34t metabolically programmed CAR transduced T-cells — This is a single-center, nonrandomized, open-label dose-escalation study followed by dose-expansion of CD19- CD34t metabolically programmed CAR T-cell therapy in adult patients with relapsed or refractory CD19 B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Check if I qualifyExtracted eligibility criteria
Cancer type
Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: CD19 overexpression (positive)
CD19+ aggressive non-Hodgkin lymphoma ... CD19+ indolent non-Hodgkin lymphoma ... Mantle cell Lymphoma ... CLL/SLL ... must have a tissue biopsy after completion of CD19 targeted therapy noting CD19 expression by either flowcytometry or immunohistochemistry (IHC). CD19 expression must be sufficient per PI/Co-I
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — aggressive lymphoma: relapse or persistent disease after ≥ 2 lines OR refractory/relapse within 12 months of 1st line OR refractory/relapse after ≥ 1 line but not a candidate for autologous stem cell transplant; Burkitt lymphoma: ≥ 1 line
Aggressive lymphoma: relapse or persistent disease after ≥ 2 lines of systemic therapy OR refractory disease or relapse within 12 months of completion of 1st line systemic therapy OR refractory disease or relapse ≥ 1 line of therapy but not a candidate for autologous stem cell transplant; Burkitt lymphoma: ≥ 1 line
Must have received: systemic therapy — indolent lymphoma: relapse or persistent disease after ≥ 2 lines (neither single agent rituximab nor radiation qualify as a line)
Indolent lymphoma: relapse or persistent disease after ≥ 2 lines of systemic therapy. (Neither single agent rituximab or radiation qualify as a line of therapy.)
Must have received: systemic therapy — mantle cell lymphoma: relapse or persistent disease after ≥ 1 line (neither single agent rituximab nor radiation qualify as a line)
Mantle cell lymphoma: relapse or persistent disease after ≥ 1 line of systemic therapy. Neither single agent rituximab or radiation qualify as a line of therapy.
Must have received: systemic chemoimmunotherapy, BTK inhibitor, BCL-2 inhibitor, or PI3 kinase inhibitor — CLL/SLL: evidence of progression or intolerance after ≥ 2 lines (neither single agent rituximab/obinutuzumab nor radiation qualify as a line)
CLL/SLL: evidence of progression or intolerance after ≥ 2 lines of therapy. The following will qualify as a line of therapy for CLL/SLL: systemic chemoimmunotherapy (e.g. BR, FCR, etc), BTK inhibitor, BCL-2 inhibitor, or PI3 Kinase inhibitor. Neither single agent rituximab/obinutuzumab or radiation qualify as a line of therapy.
Cannot have received: autologous stem cell transplant
Exception: within the last 60 days
Participants with history of autologous stem cell transplant within the last 60 days
Cannot have received: allogeneic stem cell transplant
Exception: within the last 90 days
Participants with history of allogeneic stem cell transplant within the last 90 days
Cannot have received: CAR T-cell therapy
Exception: within the last 180 days
Participants with history of CAR T-cell therapy within the last 180 days
Lab requirements
Blood counts
Platelet count ≥ 50,000 cells/mm3; ANC ≥ 750 cells/mm3; Absolute lymphocyte count ≥ 150 cells/mm3
Kidney function
Serum creatinine ≤ 2 mg/dL or creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 60 mL/min
Liver function
Serum bilirubin ≤ 1.5 X ULN unless attributed to Gilbert's syndrome or hemolysis or lymphoma involvement
Cardiac function
No clinically significant ECG findings per PI/Co-I
Adequate organ function: Bone marrow function ... Hepatic function ... Cardiac ... Pulmonary ... Renal function ...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Hollings Cancer Center at Medical University of South Carolina · Charleston, South Carolina
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