Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment for MRD-Positive B-ALL Patients in CR1
Recruiting
Phase 2Interventional Study
Acute Lymphoblastic Leukemia
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
16 – 70
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
20 (estimated)
Sponsor
Ruijin Hospital · Other
Who this trial is looking for
This trial is looking for adults with a type of blood cancer called B-ALL who are in their first complete remission but still have some remaining cancer cells. Taking part involves undergoing a special blood collection process, receiving treatment that helps clear your existing blood cells, and then getting an infusion of a new type of therapy called CAR-T cells.
Are You a Good Fit for This Trial?
Rules you outInherited bone marrow failure syndromeActive systemic autoimmune diseaseCongestive heart failureActive infection
You may be able to join if
I am between 16 and 70 years old.
I have been diagnosed with Ph-negative or Ph-positive B-ALL.
I am in my first complete remission but still have some cancer cells.
I have enough healthy organs to participate.
I have signed the informed consent form.
You may not be able to join if
I have received CAR-T cell therapy before.
I have a history of active autoimmune disease.
I have a recent heart condition or severe arrhythmia.
I have active infections right now.
I have a serious history of deep vein thrombosis or pulmonary embolism in the past six months.
I have uncontrolled diabetes.
I have participated in another clinical trial recently.
I have had a live vaccine in the past six weeks.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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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 extramedul…
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.
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