inaticabtagene autoleucel (inati-cel; cnct19) treatment for mrd-positive b-all patients in cr1

Conditions: Acute Lymphoblastic Leukemia

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.


Eligibility criteria:
inclusion criteria: * age between ≥16 and ≤70 years at screening, no gender restrictions * ecog score of 0-1 at screening * newly diagnosed ph-negative b-all, mrd positive(bone marrow mrd ≥0.01% by flow cytometry) in cr1 (with \<5% blasts in bone marrow, no blasts in peripheral blood, no extramedullary disease)after induction chemotherapy or consolidation chemotherapy. * newly diagnosed ph-positive b-all, mrd positive(bone marrow mrd ≥0.01% by flow cytometry or bcr-abl1 \>0.01% detected by qpcr) in cr1 (with \<5% blasts in bone marrow, no blasts in peripheral blood, no extramedullary disease) . * at diagnosis of b-all,cd19 expression of leukemic cells is positive by flow cytometry in bone marrow or peripheral blood. * appropirate organ function, meeting the following criteria: 1. aspartate aminotransferase (ast) ≤3 times the upper limit of normal (uln); 2. alanine aminotransferase (alt) ≤3 times uln; 3. total bilirubin ≤2 times uln (for patients with gilbert's syndrome, total bilirubin ≤3.0 times uln and direct bilirubin ≤1.5 times uln); 4. serum creatinine ≤1.5 times uln, or creatinine clearance ≥60 ml/min (using the cockcroft-gault formula); 5. international normalized ratio (inr) ≤1.5 times uln and activated partial thromboplastin time (aptt) ≤1.5 times uln; 6. left ventricular ejection fraction (lvef) ≥50%; 7. minimum pulmonary reserve, with oxygen saturation \>91% on room air; * meets leukapheresis standard of the study center, with no contraindications for blood cell separation; * voluntarily agrees to participate in this study and signs on the informed consent form(icf). exclusion criteria: * received car-t cell therapy before screening; * inherited bone marrow failure syndrome(ibmfs) or any other known bone marrow failure syndromes; * active systemic autoimmune diseases requiring treatment; * any of the following conditions: 1. hbsag and/or hbeag positive; 2. hbe-ab and/or hbc-ab positive with hbv-dna levels above the lower limit of quantification; 3. hcv-ab positive; 4. tp-ab positive; 5. hiv antibody positive; 6. ebv-dna or cmv-dna levels above the lower limit of quantification; * active infection at screening. * any other malignancy within the past five years before screening, excluding cases where the patient has been disease-free for more than 5 years after curative treatment or has a low risk of relapse as assessed by the investigator; * any of the following cardiac conditions: 1. nyha class iii or iv congestive heart failure; 2. severe arrhythmia requiring treatment; 3. uncontrolled hypertension or pulmonary hypertension despite standard therapy; 4. unstable angina; 5. myocardial infarction, bypass surgery, or stent placement within six months before cell retransfusion; 6. clinically significant valvular disease; 7. other cardiac conditions deemed unsuitable by the investigator; * history of epilepsy, cerebellar disease, or other active central nervous system disorders; * uncontrolled diabetes; * history of symptomatic deep vein thrombosis or pulmonary embolism within six months before screening that is not well controlled; * history of hypersensitivity to any component of the investigational product. * received a live vaccine within six weeks before screening; * life expectancy of less than three months; * participation in another interventional clinical trial and receiving investigational drugs within three months (for unapproved drugs) or within five half-lives (for approved drugs) before cell infusion, or plans to participate in another clinical trial or receive anti-cancer therapy outside the study protocol during the study period; * other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Keywords: acute lymphoblastic leukemia minimal residual disease chimeric antigen receptor t (car-t)cell