NCT06718244

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

A Clinical Study of Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment for B-Cell Acute Lymphoblastic Leukemia(B-ALL) Patients in First Complete Remission (CR1)，Minimal Residual Disease(MRD) Positive

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	single dose of Inaticabtagene autoleucel	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.

Timeline

• Start date: 2024-12-10
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2024-12-05
• Last updated: 2025-05-23

Locations

1 site across 1 country: China