AzTrials
AzTrials

Acute Lymphoblastic LeukemiaPhase 2NCT06718244

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

A Phase 2 study testing single dose of Inaticabtagene autoleucel in people with Acute Lymphoblastic Leukemia, run by Ruijin Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 16 to 70 years
Conditions the study is for
Acute Lymphoblastic Leukemia
What is being tested?
single dose of Inaticabtagene autoleucel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
10 Dec 2024to 31 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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:
Show all 15Show fewer
  • 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).

Who cannot join

  • 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;
Show all 28Show fewer
  • 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;
  • Uncontrolled hypertension or pulmonary hypertension despite standard therapy;
  • Unstable angina;
  • Myocardial infarction, bypass surgery, or stent placement within six months before cell retransfusion;
  • Clinically significant valvular disease;
  • Other cardiac conditions deemed unsuitable by the investigator;
  • History of epilepsy, cerebellar disease, or other active central nervous system disorders;
  • Uncontrolled diabetes;
  • History of symptomatic deep vein thrombosis or pulmonary embolism within six months before screening that is not well controlled;
  • History of hypersensitivity to any component of the investigational product.
  • Received a live vaccine within six weeks before screening;
  • Life expectancy of less than three months;
  • Participation in another interventional clinical trial and receiving investigational drugs within three months (for unapproved drugs) or within five half-lives (for approved drugs) before cell infusion, or plans to participate in another clinical trial or receive anti-cancer therapy outside the study protocol during the study period;
  • Other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jiayi Ren, MD contact

+86 13651996101

renjiayi94@163.com

China1 site, 1 recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Jin Wang, PhD, +86 13524945202, jinwang@shsmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Being tested
single dose of Inaticabtagene autoleucel
Keywords
Acute Lymphoblastic Leukemia, Minimal Residual Disease, Chimeric Antigen Receptor T (CAR-T)Cell
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • single dose of Inaticabtagene autoleucelBiological

    Also called Inati-cel, CNCT-19

    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 groups in NCT06718244
Study groupRoleWhat they receive
intervention groupExperimentalAdministration with Inaticabtagene autoleucel CD19 CAR-T cells in the MRD positive B-ALL patients in CR1.
Receives: Biological: single dose of Inaticabtagene autoleucel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 24 months

Secondary outcomes (6)

  1. Duration of MRD negativity

    Time from the first assessment of MRD negative to the first assessment of MRD positive or death from any cause.Bone marrow of every patient will be analysed by multiparameter flow cytometry or/and RT-qPCR for MRD evaluation.

    Measured: till the end of the study, up to 5 years

  2. Relapse-free survival (RFS)

    Interval from the date of transfusion of the Inati-cel to the time of hematological recurrence or death from any cause. Evaluation of RFS will be based on follow-up results.

    Measured: till the end of the study, up to 5 years

  3. Overall survival (OS)

    Interval from the date of the feedback to the time of death due to any reason. Evaluation of OS will be based on follow-up results.

    Measured: till the end of the study, up to 5 years

  4. incidence of adverse events

    The proportion of patients who have adverse events after Inati-cel transfusion.Adverse events will be assessed by CTCAE v5.0

    Measured: up to 24 months

  5. Pharmacokinetics characteristics of Inati-cel

    Including duration of CAR T cells, relative proportion of CAR-T cells and absolute counts of CAR-T cells.These will be evaluated by multiparameter flow cytometry.

    Measured: till the end of the study, up to 5 years

  6. exploratory biomarker research

    A small amount of blood or bone marrow will be collected for further biomarker research, including flowcytometric analysis of lymphocyte subsets, multiomics analysis of leukenic cells and CAR-T cells, in vivo and in vitro experiments on drug interference in CAR-T therapy.

    Measured: till the end of the study, up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2024
  2. Study start10 Dec 2024
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06718244
Sponsor's protocol ID
(2024) Ruijin Ethics No.447
Status last verified
Dec 2024
First submitted
26 Nov 2024
Last updated
23 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing single dose of Inaticabtagene autoleucel in people with Acute Lymphoblastic Leukemia, run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jiayi Ren, MD (+86 13651996101, renjiayi94@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRD negativity rate (time frame: up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06718244.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in