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Acute Lymphoblastic LeukemiaPhase 2JUVENTAS-ALL05NCT06777264

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

A Phase 2 study testing Biological: single dose of Inaticabtagene autoleucel in people with Acute Lymphoblastic Leukemia and B Cell ALL, run by First Affiliated Hospital of Zhejiang University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 14 to 70 years
Conditions the study is for
Acute Lymphoblastic Leukemia, B Cell ALL
What is being tested?
Biological: 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
No sites listed yet
Study dates
15 Jan 2025to 15 Jan 2027
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 14 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age ≥14 years and ≤70 years at screening, with no restrictions on gender.
  • ECOG performance status of 0 to 1.
  • Newly diagnosed B-ALL within 12 months and achieving CR1 after standard induction chemotherapy. This includes B-ALL patients with <5% bone marrow blasts, no blasts in peripheral blood, and no extramedullary leukemia. Diagnosis and chemotherapy regimen follow the Chinese Guidelines for Diagnosis and Treatment of Adult Acute Lymphoblastic Leukemia (2021 Edition).
  • At the time of B-ALL diagnosis, leukemia cells in bone marrow or peripheral blood confirmed as CD19-positive via flow cytometry.
  • Adequate organ function meeting the following criteria:
  • Aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN).
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  • Alanine aminotransferase (ALT) ≤3× ULN.
  • Total bilirubin ≤2× ULN (for patients with Gilbert's syndrome, total bilirubin ≤3.0× ULN and direct bilirubin ≤1.5× ULN).
  • Serum creatinine ≤1.5× ULN, or creatinine clearance ≥60 mL/min (calculated using the Cockcroft-Gault formula).
  • International Normalized Ratio (INR) ≤1.5× ULN and activated partial thromboplastin time (APTT) ≤1.5× ULN.
  • Minimum pulmonary reserve defined as ≤Grade 1 dyspnea and oxygen saturation >91% on room air.
  • No intent or eligibility for hematopoietic stem cell transplantation.
  • Meets the leukapheresis standards of the study center, with no contraindications for apheresis.
  • Women of childbearing potential must have a negative blood/urine pregnancy test during the Inati-cel screening period and before preconditioning (results within three days prior to preconditioning). All male and female patients of childbearing potential must agree to use effective contraception throughout the study and for at least two years following study treatment. A female is considered of childbearing potential if biologically capable of having children and engaging in regular sexual activity. Women are considered not of childbearing potential if they meet at least one of the following:
  • History of hysterectomy, bilateral oophorectomy, or bilateral tubal ligation.
  • Medically confirmed ovarian failure.
  • Postmenopausal (absence of menstruation for at least 12 consecutive months).

Who cannot join

  • Diagnosis of Burkitt lymphoma/leukemia, heterozygous or double-hit leukemia, or chronic myeloid leukemia in blast crisis.
  • Presence of ≥5% blasts in the bone marrow or peripheral blood, or evidence of extramedullary leukemia before screening or preconditioning.
  • Prior treatment with CAR-T cell therapy or hematopoietic stem cell transplantation (HSCT) before screening or preconditioning.
  • Genetic syndromes associated with bone marrow failure, including Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other known bone marrow failure syndromes.
  • Presence of any of the following conditions:
  • Positive for HBsAg and/or HBeAg.
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  • Positive for HBe-Ab and/or HBc-Ab with HBV-DNA levels above the detectable threshold.
  • Positive for HCV-Ab.
  • Positive for TP-Ab.
  • EBV-DNA or CMV-DNA levels above the detectable threshold.
  • Positive for HIV antibodies.
  • Diagnosis of other malignancies within the past 5 years, unless the tumor was curatively treated, with a follow-up period exceeding 5 years, and a low risk of recurrence as assessed by the investigator.
  • Presence of any of the following cardiac conditions:
  • Left ventricular ejection fraction (LVEF) ≤45%.
  • Congestive heart failure classified as NYHA class III or IV.
  • Severe arrhythmias requiring treatment or clinically significant conduction abnormalities on ECG, including QTc ≥480 ms (QTcB = QT/RR^1/2).
  • Uncontrolled hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg) or pulmonary hypertension despite standard treatment.
  • Unstable angina.
  • Myocardial infarction or coronary artery bypass/stent surgery within the past 6 months.
  • Clinically significant valvular disease.
  • Other cardiac conditions deemed unsuitable for study enrollment by the investigator.
  • History of epilepsy, ischemic or hemorrhagic stroke, cerebellar disease, or other active central nervous system disorders.
  • Clinically significant pleural effusion at the time of screening.
  • History of deep vein thrombosis or pulmonary embolism within the past 6 months.
  • Known hypersensitivity to any components of the investigational products used in the trial.
  • Receipt of live vaccines within 6 weeks prior to screening.
  • Presence of active infections at the time of screening.
  • An expected survival of less than 3 months.
  • Participation in other interventional clinical studies involving investigational drugs:
  • For investigational drugs not yet approved, the last dose administered less than 3 months before cell infusion.
  • For approved drugs, the last dose administered less than 5 half-lives before cell infusion.
  • Any other conditions deemed unsuitable for study participation by the investigator.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jie Jin contact

0571-87236898

jiej0503@163.com

About this study

Official title: Clinical Study on Inaticabtagene Autoleucel (Inati-cel; CNCT19) Injection for Adolescents and Adults With B-Cell Acute Lymphoblastic Leukemia in First Complete Remission (CR1)

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.

Being tested
Biological: single dose of Inaticabtagene autoleucel
Keywords
Chimeric Antigen Receptor T (CAR-T)Cell, Acute Lymphoblastic Leukemia, B-ALL, Inaticabtagene Autoleucel
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma

What participants receive

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

  • Biological: 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.

Study groups in NCT06777264
Study groupRoleWhat they receive
Biological: Inaticabtagene autoleucelExperimentalAdministration of Inaticabtagene Autoleucel (CD19 CAR-T cells) in newly diagnosed B-ALL patients aged 14 to 70 years in their first complete remission (CR1).
Receives: Biological: Biological: single dose of Inaticabtagene autoleucel

What is being measured

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

  1. 2-year DFS rate (2yDFSR)

    The proportion of patients who remain free from bone marrow disease relapse or death from any cause, assessed after a median follow-up of 2 years

    Measured: Up to 2 years

  2. 2-year OS rate (2yDFSR)

    The proportion of patients who remain alive after a median follow-up of 2 years

    Measured: Up to 2 years

  3. DFS

    The time from Inati-cel infusion to morphological relapse of B-ALL in the bone marrow, or death from any cause (whichever occurs first).

    Measured: Up to 2 years

  4. OS

    The time from Inati-cel infusion to death from any cause

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

Secondary outcomes (5)

  1. Proportion of patient underwent subsequent hematopoieticstem cell transplantation

    Proportion of patient underwent subsequent hematopoieticstem cell transplantation

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

  2. MRD negativity rate

    the proportion of patients achieved undetectable levels of minimal residual disease at Day 28、Month 2，3，6 by flow cytometry and at Day 28 by NGS

    Measured: 6 months

  3. Maximum observed concentration(Cmax)

    Measured: 6 months

  4. Time of Cmax (Tmax)

    Measured: 6 months

  5. Partial area under the concentration-time curve (from time zero to 28days after dosing , AUC 0-28 day)

    Measured: 6 months

Timeline

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

  1. First posted15 Jan 2025
  2. Study start15 Jan 2025 (estimated)
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completion15 Jan 2027 (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
NCT06777264
Sponsor's protocol ID
[2024]TXB ethic review NO.023
Acronym
JUVENTAS-ALL05
Status last verified
Dec 2024
First submitted
31 Dec 2024
Last updated
15 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biological: single dose of Inaticabtagene autoleucel in people with Acute Lymphoblastic Leukemia and B Cell ALL, run by First Affiliated Hospital of Zhejiang University.

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 17 inclusion and 32 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: opening soon, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

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 Jie Jin (0571-87236898, jiej0503@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year DFS rate (2yDFSR) (time frame: Up to 2 years). The study lists 4 primary outcomes in all. 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 NCT06777264.

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 15 Jan 2025.

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JUVENTAS-ALL05 Clinical Trial NCT06777264 | AzTrials