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

Sponsor
Ruijin Hospital
Study ID
NCT06718244
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • single dose of Inaticabtagene autoleucel — BIOLOGICAL
    Inaticabtagene autoleucel will be transfusioned intravenously at the recommended dose of 0.5×10\^8 (ranging 0.2-0.6×10\^8) viable CAR-T cells. If the quantity of CAR-T cells of the patient is sufficient, after the patient receives the first CAR-T transfusion 5\~6 months，they will receive a second CAR-T cell transfusion. The aim of the second transfusion is to prolong the duration of CAR-T in the patient's body and prolong the patient's DOR. The dose and procedures of the second transfusion are the same as those for the first transfusion. After the second infusion, the patient will receive evaluation based on the day of the second transfusion as Day0.

Study Details

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.

Key Dates

First listed
Dec 5, 2024
Start date
Dec 10, 2024
Status verified
Dec 2024
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: intervention group
    Administration with Inaticabtagene autoleucel CD19 CAR-T cells in the MRD positive B-ALL patients in CR1.

Primary Outcome Measure

MRD negativity rate [ Time Frame: up to 24 months ]

Central Contacts

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