OncoMatch/Clinical Trials/NCT06593145
CAR T Cells in the Treatment of Refractory and Relapsed CD19+ B Cell Neoplasms
Is NCT06593145 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies FCTX-CL19-1 (Tarcidomgen Kimleucel) for acute lymphoblastic leukemia (all).
Treatment: FCTX-CL19-1 (Tarcidomgen Kimleucel) — One arm, open label study to assess the clinical use of Investigational Medicinal Product FCTX-CL19-1 (scientific name: Tarcidomgen Kimleucel) containing autologous anti-CD19 CAR T cells with a preliminary determination of the safety of intravenous IMP administration in patients diagnosed with refractory and relapsed CD19 + B cell neoplasms.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Biomarker criteria
Required: CD19 overexpression
Confirmed CD19 expression on malignant cells
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: hematopoietic cell transplantation — relapsed B-ALL
relapse after hematopoietic cell transplantation
Must have received: systemic treatment — B-ALL, DLBCL, MCL
second or more relapse in patients when transplantation is contraindicated; refractory or relapse or after at least 2 lines of systemic treatment; relapsing or refractory after at least 2 lines of systemic treatment
Cannot have received: anti-CD19 CAR-T cell therapy
Previous use of anti-CD19 CART therapy
Lab requirements
Kidney function
Serum creatinine clearance >60 ml/min (by Cockcroft-Gault formula)
Liver function
ALT/AST <2.5x UNL and bilirubin <1.5 mg/dl (<4 mg/dl for patients with Gilbert syndrome)
Cardiac function
Ejection fraction (EF) >50% confirmed in ECHO with no signs of exudation in pericardium during 6 weeks before screening
Sufficient general condition of organs on screening visit: ALT/AST <2.5 of UNL and bilirubin <1.5 mg/dl (<4 mg/dl for patients with Gilbert syndrome); Ejection fraction (EF) >50% confirmed in ECHO with no signs of exudation in pericardium during 6 weeks before screening; Saturation of arterial blood >93% with no oxygen insufflation, with no significant exudation in pleural cavity; Serum creatinine clearance >60 ml/min (by Cockcroft-Gault formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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