OncoMatch/Clinical Trials/NCT06718244

Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment for MRD-Positive B-ALL Patients in CR1

Is NCT06718244 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies single dose of Inaticabtagene autoleucel for acute lymphoblastic leukemia.

Phase 2RecruitingRuijin HospitalNCT06718244Data as of May 2026

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.

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Extracted eligibility criteria

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)

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.

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