Actively Recruiting
Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment for MRD-Positive B-ALL Patients in CR1
Led by Ruijin Hospital · Updated on 2025-05-23
20
Participants Needed
1
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment for MRD-Positive B-ALL Patients in CR1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 16 and 70 years at screening, no gender restrictions
- ECOG score of 0-1 at screening
- Newly diagnosed Philadelphia chromosome-negative B-ALL with MRD positive (bone marrow MRD 90.01% by flow cytometry) in first complete remission after induction or consolidation chemotherapy
- Newly diagnosed Philadelphia chromosome-positive B-ALL with MRD positive (bone marrow MRD 90.01% by flow cytometry or BCR-ABL1 90.01% by qPCR) in first complete remission
- CD19 expression positive on leukemic cells by flow cytometry in bone marrow or peripheral blood at B-ALL diagnosis
- Appropriate organ function defined by specific liver enzymes, bilirubin, creatinine, coagulation times, heart function (LVEF 950%), and oxygen saturation above 91% on room air
- Meets leukapheresis standards with no contraindications for blood cell separation
- Voluntary participation with signed informed consent form
You will not qualify if you...
- Previous CAR-T cell therapy before screening
- Inherited bone marrow failure syndrome or other known bone marrow failure syndromes
- Active systemic autoimmune diseases requiring treatment
- Positive tests for hepatitis B surface antigen or envelope antigen, or hepatitis C antibody, or syphilis antibody, or HIV antibody
- Epstein-Barr virus or cytomegalovirus DNA levels above detection limits
- Active infection at screening
- Any other malignancy within the past five years unless disease-free for over five years or low relapse risk
- Specific cardiac conditions including advanced congestive heart failure, severe arrhythmia, uncontrolled hypertension, recent myocardial infarction or surgery, significant valve disease, or other unsuitable cardiac issues
- History of epilepsy, cerebellar disease, or other active central nervous system disorders
- Uncontrolled diabetes
- Recent symptomatic deep vein thrombosis or pulmonary embolism within six months not well controlled
- Hypersensitivity to any component of the investigational product
- Received a live vaccine within six weeks before screening
- Life expectancy under three months
- Participation in another interventional clinical trial with investigational drugs within three months or plans to receive anti-cancer therapy outside this study during the study period
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Actively Recruiting
Research Team
J
Jiayi Ren, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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