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

NCT06718244 | Recruiting Phase 2

• 1 other identifier: (2024) Ruijin Ethics No.447
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acute Lymphoblastic Leukemia; Minimal Residual Disease; Chimeric Antigen Receptor T (CAR-T)Cell

Outcome Measures

Primary Outcomes (1)

• MRD negativity rate

  The proportion of patients who reach MRD negative.Bone marrow of every patient will be analysed by multiparameter flow cytometry or/and RT-qPCR for MRD evaluation.

  up to 24 months

Secondary Outcomes (6)

• Duration of MRD negativity

  till the end of the study, up to 5 years

• Relapse-free survival (RFS)

  till the end of the study, up to 5 years

• Overall survival (OS)

  till the end of the study, up to 5 years

• incidence of adverse events

  up to 24 months

• Pharmacokinetics characteristics of Inati-cel

  till the end of the study, up to 5 years

Study Arms (1)

intervention group

EXPERIMENTAL

Administration with Inaticabtagene autoleucel CD19 CAR-T cells in the MRD positive B-ALL patients in CR1.

Biological: single dose of Inaticabtagene autoleucel

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.

Also known as: Inati-cel, CNCT-19

intervention group

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between ≥16 and ≤70 years at screening, no gender restrictions
• ECOG score of 0-1 at screening
• Newly diagnosed Ph-negative B-ALL, MRD positive(bone marrow MRD ≥0.01% by flow cytometry) in CR1 (with \<5% blasts in bone marrow, no blasts in peripheral blood, no extramedullary disease)after induction chemotherapy or consolidation chemotherapy.
• Newly diagnosed Ph-positive B-ALL, MRD positive(bone marrow MRD ≥0.01% by flow cytometry or BCR-ABL1 \>0.01% detected by qPCR) in CR1 (with \<5% blasts in bone marrow, no blasts in peripheral blood, no extramedullary disease) .
• At diagnosis of B-ALL,CD19 expression of leukemic cells is positive by flow cytometry in bone marrow or peripheral blood.
• Appropirate organ function, meeting the following criteria:
• Aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN);
• Alanine aminotransferase (ALT) ≤3 times ULN;
• Total bilirubin ≤2 times ULN (for patients with Gilbert's syndrome, total bilirubin ≤3.0 times ULN and direct bilirubin ≤1.5 times ULN);
• Serum creatinine ≤1.5 times ULN, or creatinine clearance ≥60 mL/min (using the Cockcroft-Gault formula);
• International Normalized Ratio (INR) ≤1.5 times ULN and activated partial thromboplastin time (APTT) ≤1.5 times ULN;
• Left ventricular ejection fraction (LVEF) ≥50%;
• Minimum pulmonary reserve, with oxygen saturation \>91% on room air;
• Meets leukapheresis standard of the study center, with no contraindications for blood cell separation;
• Voluntarily agrees to participate in this study and signs on the informed consent form(ICF).

You may not qualify if:

• Received CAR-T cell therapy before screening;
• Inherited bone marrow failure syndrome(IBMFS) or any other known bone marrow failure syndromes;
• Active systemic autoimmune diseases requiring treatment;
• Any of the following conditions:
• HBsAg and/or HBeAg positive;
• HBe-Ab and/or HBc-Ab positive with HBV-DNA levels above the lower limit of quantification;
• HCV-Ab positive;
• TP-Ab positive;
• HIV antibody positive;
• EBV-DNA or CMV-DNA levels above the lower limit of quantification;
• Active infection at screening.
• Any other malignancy within the past five years before screening, excluding cases where the patient has been disease-free for more than 5 years after curative treatment or has a low risk of relapse as assessed by the investigator;
• Any of the following cardiac conditions:
• NYHA Class III or IV congestive heart failure;
• Severe arrhythmia requiring treatment;

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jiayi Ren, MD

CONTACT

+86 13651996101; renjiayi94@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician, MD, PhD

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 5, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 23, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)