Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment for Newly Diagnosed B-cell ALL Patients in CR1

Sponsor
First Affiliated Hospital of Zhejiang University
Study ID
NCT06777264
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Biological: 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.

Study Details

This investigator-initiated, prospective, single-arm, open-label, single-center phase II study aims to evaluate the long-term survival benefit and safety of a commercial CD19 CAR-T product in newly diagnosed Philadelphia chromosome-positive or negative (Ph-positive or Ph-negative) B-cell ALL patients who achieve CR1 after induction chemotherapy. A total of 20 patients will be enrolled in the study. The primary endpoints include disease-free survival (DFS) and overall survival (OS) rates after a median follow-up of 2 years, minimal residual disease (MRD) negativity rate, and the proportion of patients undergoing subsequent hematopoietic stem cell transplantation (HSCT). The frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after infusion will also be recorded.

Key Dates

First listed
Jan 15, 2025
Start date
Jan 15, 2025
Status verified
Dec 2024
Primary completion
Dec 15, 2026
Completion
Jan 15, 2027

Study Design

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

Arms

  • Experimental: Biological: Inaticabtagene autoleucel
    Administration of Inaticabtagene Autoleucel (CD19 CAR-T cells) in newly diagnosed B-ALL patients aged 14 to 70 years in their first complete remission (CR1).

Primary Outcome Measure

2-year DFS rate (2yDFSR) [ Time Frame: Up to 2 years ]

Central Contacts

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