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 (Jun 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
Treatments studied
Chemotherapy
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04892277 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior autologous stem cell transplant, allogeneic stem cell transplant disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 positive 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.
Check if I qualify