Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment for MRD-Positive B-ALL Patients in CR1 (NCT06718244) | Clinical Trial Compass
RecruitingPhase 2
Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment for MRD-Positive B-ALL Patients in CR1
China20 participantsStarted 2024-12-10
Plain-language summary
This investigator-initiated, prospective, single-arm, open-label, single-center clinical study aims to evaluate the efficacy and safety of Inaticabtagene autoleucel (Inati-cel;CNCT19)CD19 CAR-T theraphy in adults B-ALL that are in first complete remission(CR1) with minimal residual disease (MRD) positivity. This trial will enroll 20 participants for leukapheresis and treatment with lymphodepleting chemotherapy followed by Inati-cel CAR T cell infusion. Patients will be assessed for MRD negativity rate(at months 1, 2, 3, and 6 after CAR-T transfusion), duration of MRD negativity, overall survival(OS), relapse-free survival(RFS), pharmacokinetics(PK) characteristics, incidence of adverse events(AEs), exploratory biomarker research at 1,2,3,6,9,12,15,18,21 and 24- months post Inati-cel infusion.
Who can participate
Age range16 Years – 70 Years
SexALL
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Inclusion criteria
✓. Aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN);
✓. Alanine aminotransferase (ALT) ≤3 times ULN;
✓. Total bilirubin ≤2 times ULN (for patients with Gilbert's syndrome, total bilirubin ≤3.0 times ULN and direct bilirubin ≤1.5 times ULN);
✓. Serum creatinine ≤1.5 times ULN, or creatinine clearance ≥60 mL/min (using the Cockcroft-Gault formula);
✓. International Normalized Ratio (INR) ≤1.5 times ULN and activated partial thromboplastin time (APTT) ≤1.5 times ULN;
✓. Left ventricular ejection fraction (LVEF) ≥50%;
✓. Minimum pulmonary reserve, with oxygen saturation \>91% on room air;
Exclusion criteria
✕. HBsAg and/or HBeAg positive;
✕. HBe-Ab and/or HBc-Ab positive with HBV-DNA levels above the lower limit of quantification;