OncoMatch/Clinical Trials/NCT06593145
CAR T Cells in the Treatment of Refractory and Relapsed CD19+ B Cell Neoplasms
Is NCT06593145 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06593145 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-CD19 CAR-T cell therapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 65 years or younger.
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