OncoMatch/Clinical Trials/NCT06718244
Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment for MRD-Positive B-ALL Patients in CR1
Is NCT06718244 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies single dose of Inaticabtagene autoleucel for acute lymphoblastic leukemia.
Treatment: single dose of Inaticabtagene autoleucel — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 overexpression (positive by flow cytometry in bone marrow or peripheral blood)
At diagnosis of B-ALL, CD19 expression of leukemic cells is positive by flow cytometry in bone marrow or peripheral blood
Allowed: BCR fusion with ABL1
Ph-positive B-ALL, MRD positive (bone marrow MRD ≥0.01% by flow cytometry or BCR-ABL1 >0.01% detected by qPCR) in CR1
Disease stage
Required: Stage CR1
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: induction chemotherapy
after induction chemotherapy or consolidation chemotherapy
Must have received: consolidation chemotherapy
after induction chemotherapy or consolidation chemotherapy
Cannot have received: CAR-T cell therapy
Received CAR-T cell therapy before screening
Lab requirements
Blood counts
INR ≤1.5x ULN and APTT ≤1.5x ULN
Kidney function
serum creatinine ≤1.5x ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault)
Liver function
AST ≤3x ULN; ALT ≤3x ULN; total bilirubin ≤2x ULN (≤3x ULN for Gilbert's syndrome, direct bilirubin ≤1.5x ULN)
Cardiac function
LVEF ≥50%
Appropriate organ function, meeting the following criteria: AST ≤3x ULN; ALT ≤3x ULN; total bilirubin ≤2x ULN (for patients with Gilbert's syndrome, total bilirubin ≤3.0x ULN and direct bilirubin ≤1.5x ULN); serum creatinine ≤1.5x ULN, or creatinine clearance ≥60 mL/min (using the Cockcroft-Gault formula); INR ≤1.5x ULN and APTT ≤1.5x ULN; LVEF ≥50%; minimum pulmonary reserve, with oxygen saturation >91% on room air
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06718244 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR-T cell therapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage CR1 is required.
Is there an age limit?
Yes. Patients must be 70 years or younger and at least 16 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages