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New treatment option for Acute Lymphoblastic Leukemia
Official title Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment for MRD-Positive B-ALL Patients in CR1
ClinicalTrials.gov ID: NCT06718244
What this study is testing
What is single dose of Inaticabtagene autoleucel?
single dose of Inaticabtagene autoleucel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute lymphoblastic leukemia.
Also referred to as Inati-cel, CNCT-19.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 70
You may be able to join if
- 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...
- 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%...
- At diagnosis of B-ALL,CD19 expression of leukemic cells is positive by flow cytometry in bone marrow or peripheral blood.
You likely can't join if
- 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:
- HBsAg and/or HBeAg positive;
- HBe-Ab and/or HBc-Ab positive with HBV-DNA levels above the lower limit of quantification;
See the full eligibility 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...
- 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...
- 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:
- 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;
- 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).
- 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:
- HBsAg and/or HBeAg positive;
- HBe-Ab and/or HBc-Ab positive with HBV-DNA levels above the lower limit of quantification;
- HCV-Ab positive;
- TP-Ab positive;
- HIV antibody positive;
- 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...
- Any of the following cardiac conditions:
- NYHA Class III or IV congestive heart failure;
- Severe arrhythmia requiring treatment;
- Uncontrolled hypertension or pulmonary hypertension despite standard therapy;
- Unstable angina;
- Myocardial infarction, bypass surgery, or stent placement within six months before cell retransfusion;
- Clinically significant valvular disease;
- 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 treatment 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...
- Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.