OncoMatch/Clinical Trials/NCT04892277
CD19-Directed CAR-T Cell Therapy for the Treatment of Relapsed/Refractory B Cell Malignancies
Is NCT04892277 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Autologous Anti-CD19 CAR-expressing T-lymphocytes IC19/1563 and Bendamustine for recurrent b-cell non-hodgkin lymphoma.
Treatment: Autologous Anti-CD19 CAR-expressing T-lymphocytes IC19/1563 · Bendamustine · Cyclophosphamide · Fludarabine — This phase I trial studies the effects of CD-19 directed chimeric antigen receptor (CAR)-T cell therapy for the treatment of patients with B cell malignancies that have come back (recurrent) or have not responded to treatment (refractory). CD-19 CAR-T cells use some of a patient's own immune cells, called T cells, to kill cancer. T cells fight infections and, in some cases, can also kill cancer cells. Some T cells are removed from the blood, and then laboratory, researchers will put a new gene into the T cells. This gene allows the T cells to recognize and possibly treat cancer. The new modified T cells are called the IC19/1563 treatment. IC19/1563 may help treat patients with relapsed/refractory B cell malignancies.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: CD19 positive
Relapsed or refractory CD19+ B cell malignancies
Allowed: BTK resistance mutation
Exception: Patients in stable disease (SD) or partial response (PR) with a known ibrutinib resistance mutation (BTK or phospholipase Cgamma2) may be included even if on ibrutinib therapy for less than 6 months.
Allowed: PLCG2 resistance mutation
Exception: Patients in stable disease (SD) or partial response (PR) with a known ibrutinib resistance mutation (BTK or phospholipase Cgamma2) may be included even if on ibrutinib therapy for less than 6 months.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anthracycline — at least one prior regimen unless intolerable
Two or more prior lines of therapy, at least one anthracycline containing regimen, unless intolerable.
Must have received: BTK inhibitor — Richter transformation of CLL: at least one prior treatment including prior BTK inhibition
Exception: Patients with Richter transformation of CLL are eligible if they had >= one prior treatment, including prior BTK inhibition
Must have received: BTK inhibitor (ibrutinib) — CLL/SLL: >= 6 months of second line prior BTK inhibition (e.g. venetoclax and ibrutinib)
>= two prior lines of therapy, and/or >= 6 months of second line prior BTK inhibition (e.g. venetoclax and ibrutinib)
Cannot have received: autologous stem cell transplant
Exception: allowed if >6 weeks prior to registration
Autologous stem cell transplant <= 6 weeks of registration
Cannot have received: allogeneic stem cell transplant
Exception: allowed if >100 days prior, no active GVHD, not on immunosuppression
History of allogenic stem cell transplant if was performed less than 100 days prior to registration, if patients have active graft-versus host disease (GVHD) or are if patients are on chronic immunosuppression
Lab requirements
Blood counts
Hemoglobin >= 8.0 g/dL; ANC >= 500/mm^3; Platelet count >= 30,000/mm^3
Kidney function
Calculated creatinine clearance >= 45 ml/min using the Cockcroft-Gault formula
Liver function
Total bilirubin <= 2.0 mg/dL (Gilbert's syndrome: <= 3.0 x ULN and direct bilirubin <= 1.5 x ULN); ALT and AST <= 3 x ULN
Cardiac function
Cardiac ejection fraction >= 50% and no evidence of clinically significant pericardial effusion as determined by ECHO or MUGA scan
Hemoglobin >= 8.0 g/dL; ANC >= 500/mm^3; Platelet count >= 30,000/mm^3; Total bilirubin <= 2.0 mg/dL (Gilbert's syndrome: <= 3.0 x ULN and direct bilirubin <= 1.5 x ULN); ALT and AST <= 3 x ULN; Calculated creatinine clearance >= 45 ml/min; Cardiac ejection fraction >= 50% and no evidence of clinically significant pericardial effusion
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Rochester · Rochester, Minnesota
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