OncoMatch/Clinical Trials/NCT05281809
Local Manufacture of CAR T-Cell Products for the Treatment of B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia
Is NCT05281809 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Chimeric Antigen Receptor (CAR) T-Cell Product (Autologous) for b-cell lymphoma.
Treatment: Chimeric Antigen Receptor (CAR) T-Cell Product (Autologous) — This trial aims to demonstrate the feasibility of this approach to reliably generate product and to safely administer the product to patients who have B-Cell Lymphoma and B-Acute Lymphoblastic Leukemia.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Acute Lymphoblastic Leukemia
Diffuse Large B-Cell Lymphoma
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: CD19 overexpression
Demonstration of CD19 expression by immunohistochemistry or flow cytometry on a pathological specimen of lymphoma or ALL cells at any time in the course of prior treatment.
Prior therapy
Must have received: conventional (immuno)chemotherapy (rituximab, cyclophosphamide, doxorubicin, prednisone, bendamustine) — lymphoma: at least 2 lines; B-ALL: at least 1 line or refractory to first line
failed at least 2 lines of therapy in the case of lymphoma and one line if the diagnosis is B-ALL or be refractory (no response or progressive disease) to first line therapy. A line of therapy must include conventional (immuno) chemotherapy (e.g. rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHOP) or Bendamustine plus Rituximab (BR) in the case of lymphoma) administered for at least 2 cycles.
Must have received: chemotherapy for transformed disease — transformed indolent lymphoma: at least one line for transformed disease for at least two cycles
Subjects with pathological and clinical evidence of transformed indolent lymphoma (FL, CLL, MZL or LPL) are eligible for participation on this trial if they have received at least one line of therapy for transformed disease for at least two cycles regardless of response.
Cannot have received: single agent anti-CD20 monoclonal antibody (rituximab, obinutuzumab)
Single agent anti-CD20 monoclonal antibody (e.g. rituximab, obinutuzumab) is not considered for the purposes of these criteria to count as a line of therapy.
Lab requirements
Blood counts
Hemoglobin < 8 gm/dL or dependent upon transfusion to maintain ≥ 8 gm/dL; WBC < 2,000/mm3; Platelet count < 50,000/mm3 or dependent upon transfusion to maintain ≥ 50,000/mm3
Kidney function
Creatinine > 2.0x ULN or calculated creatinine clearance ≤ 40 mL/min
Liver function
AST/SGOT > 2.0x ULN, ALT/SGPT > 2.0x ULN, total bilirubin > 2.0x ULN (unless Gilbert's Syndrome >3.0x ULN)
Cardiac function
Cardiac ejection fraction ≥ 0.45 by MUGA or echocardiography
AST (Aspartate transaminase)/SGOT(serum glutamic-oxaloacetic transaminase) > 2.0 times the upper limit of normal ALT (alanine aminotransferase)/SGPT (serum glutamic-pyruvic transaminase) > 2.0 times the upper limit of normal Total bilirubin > 2.0 times the upper limit of normal, unless subject has Gilbert's Syndrome (>3.0 times the upper limit of normal) Hemoglobin < 8 gm/dL or dependent upon transfusion to maintain ≥ 8 gm/dL White blood cell count < 2,000/mm3 Platelet count < 50,000/mm3 or dependent upon transfusion to maintain ≥ 50,000 mm Creatinine > 2.0 times the upper limit of normal or calculated creatinine clearance ≤ 40 mL/min. Cardiac ejection fraction ≥ 0.45 by MUGA (multigated acquisition) or echocardiography.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- AHN Cancer Institute - West Penn Hospital · Pittsburgh, Pennsylvania
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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