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B-cell Acute Lymphoblastic LeukemiaPhase 1/2NCT05667506

A Study of CNCT19 Treatment in Children and Adolescent r/r ALL Patients(Pediatric)

A Phase 1/2 study testing single dose of CNCT19 in people with B-cell Acute Lymphoblastic Leukemia, run by Juventas Cell Therapy Ltd. at 9 sites 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
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Trial summary

This is a multi-center, phase Ib/II trial to evaluate the safety and efficacy of CNCT19 treatment in Children and Adolescent (pediatric) patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL). Read more about this study

Who is it for?
Ages 3 to 18 years
Conditions the study is for
B-cell Acute Lymphoblastic Leukemia
What is being tested?
single dose of CNCT19
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
9 sitesChina
Study dates
7 Feb 2023to 30 May 2027
Phase
Phase 1/2
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 3 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Signed written informed consent prior to any study procedures (patient and/or parent or legal guardian)
  • Age 3 to 18. Weight ≥10kg
  • Relapsed or refractory acute lymphoblastic leukemia (ALL).
  • Documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months before screening.
  • Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening.
  • Karnofsky (age ≥ 16 years) performance status ≥ 70 or Lansky (age < 16 years) performance status ≥ 50 at screening
  • Organ function requirements: All patients must have adequate renal and liver functions

Who cannot join

  • Active Central Nervous System (CNS) involvement by malignancy.
  • Isolated extra-medullary disease relapse.
  • Patients with Burkitt's lymphoma/leukemia, mixed phenotypic acute leukemia and Chronic Myelogenous Leukemia in Blast Crisis
  • History of concomitant genetic syndrome
  • Patients with acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD within 4 weeks before screening.
  • Active systemic autoimmune disease
Show all 14Show fewer
  • Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti-HCV positive).
  • Patients with active infections at screening.
  • Patients who received specified chemotherapy before CNCT19 infusion
  • Radiotherapy before CNCT19 infusion:
  • Non-CNS site of radiation completed < 4 weeks prior to CNCT19 Infusion; CNS directed radiation completed < 8 weeks prior to CNCT19 infusion.
  • Donor lymphocyte infusion (DLI) must be stopped > 6 week prior to CNCT19 infusion.
  • Has had treatment with any prior CAR-T therapy.
  • Life expectancy < 3 months.

Trial locations and contacts

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

Hui Ding contact

+86-010-65960098

dinghui@juventas.cn

9 sites in 1 country

China9 sites, 9 recruiting

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Xianmin Guan, Dr.

    Recruiting

  • Guangzhou Women and Children's Medical Center

    Guangzhou, Guangdong

    Yingyi He, Dr.

    Recruiting

  • Nanfang Hospital

    Guangzhou, Guangdong

    Hongsheng Zhou, Dr.

    Not yet recruiting

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui

    Ningling Wang, Dr.

    Not yet recruiting

  • The First Affilicated Hospital of Nanchang University

    Nanchang, Jiangxi

    Fei Li, Dr.

    Recruiting

  • Children's Hospital of Nanjing Medical University

    Nanjing, Jiangsu

    Yongjun Fang, Dr.

    Recruiting

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin Municipality

    Xiaofan Zhu, MD, +86-010-65960098, xfzhu@ihcams.ac.cn

    Xiaoming Liu, MD, +86-010-65960098, liuxiaoming@ihcams.ac.cn

    Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science of Technology

    Wuhan, Hubei

    Heng Mei, Dr.

    Not yet recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

    Kailin Xu, Dr.

    Recruiting

Other trials in China

About this study

Official title: A Phase Ib/II, Single Arm, Multi-center Study Evaluating the Safety and Efficacy of CNCT19 in Children and Adolescent(Pediatric) Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL)

This is a multi-center, phase Ib/II trial to evaluate the safety and efficacy of CNCT19 treatment in Children and Adolescent (pediatric) patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL).

Read the detailed description

This trial is a multi-center, open label, single-arm, phase Ib/II trial to evaluate the safety and efficacy of CNCT19 in Children and Adolescent(aged 3~18 years old) patients (pediatric) with r/r B-cell ALL.

The phase Ib part of the trial is to evaluate the safety, optimal dose of CNCT19, Pharmacokinetics/Pharmacodynamics(PK/PD)and preliminary efficacy in the treatment of Children and Adolescent patients with r/r B-cell ALL.

The phase II part of the trial is to evaluate the efficacy and safety of CNCT19 in in the treatment of Children and Adolescent patients with r/r B-cell ALL.

The study includes screening, pre-treatment (Cell Product manufacture \& lymphodepletion), CNCT19 infusion , safety and efficacy follow-up, and survival follow-up. All subjects who have received CNCT19 infusion will be followed for up to 2 years.

Being tested
single dose of CNCT19
Keywords
CNCT19, Cluster of differentiation antigen 19(CD19), CD19-directed CAR-T cells
Medical subject headings
Burkitt Lymphoma

What participants receive

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

  • single dose of CNCT19Biological

    Autologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously.

    Lymphodepletion treatment:

    Drugs:Fludarabine Drugs: Cyclophosphamide

Study groups in NCT05667506
Study groupRoleWhat they receive
Single dose of CNCT19ExperimentalA conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CNCT19.
Receives: Biological: single dose of CNCT19

What is being measured

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

  1. Overall Remission Rate (ORR)

    ORR is defined as Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi) per NCCN classification, as determined by Independent Review Committee (IRC)

    Measured: within 3 months

Secondary outcomes (16)

  1. Overall complete Remission Rate (ORR) with minimal residual disease (MRD) negativity as determined by IRC and Investigators

    MRD negativity status as determined using flow cytometry

    Measured: within 3 months

  2. Overall Remission Rate (ORR) as determined by IRC and Investigators

    The Investigators' evaluation results of ORR will be utilized in the sensitivity analysis

    Measured: at the end of month 3

  3. Overall Remission Rate (ORR) with minimal residual disease (MRD) negativity as determined by IRC and Investigators

    MRD negativity as determined using flow cytometry

    Measured: at the end of Month 3

  4. Best overall response (BOR)

    The proportion of patients who have achieved the best response (CR or CRi) after CNCT19 treatment

    Measured: up to 2 years

  5. Duration of remission (DOR)

    DOR is defined as the time between their first complete response per independent review to relapse or any death in the absence of documented relapse

    Measured: to data cutoff date

  6. Allogeneic Stem Cell Transplant (Allo-SCT) rate

    The proportion of patients who have received Allo-SCT after CNCT19 treatment

    Measured: First infusion date of CNCT19 to data cutoff date(up to 2 years)

  7. Relapse Free Survival (RFS)

    RFS is defined as the time from the CNCT19 infusion date to the date of disease relapse or death from any cause.

    Measured: 2 years

  8. Overall survival (OS)

    OS is defined as the time from the CNCT19 Cell Injection infusion to the date of death from any cause

    Measured: 2 years

  9. Treatment-Emergent Adverse Events

    Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAE) and Severity of TEAE

    Measured: up to 2 years

  10. Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities

    Clinically significant laboratory abnormalities were defined as per investigator's discretion

    Measured: From CNCT19 infusion to date of data cutoff (maximum: 2 years)

  11. In vivo cellular Pharmacokinetic (PK) profile of CNCT19

    To characterize the concentration of CAR-T cell in peripheral blood, bone marrow and cerebral spinal fluid (CSF, if available)by Flow Cytometry and quantitative polymerase chain reaction(qPCR).

    Measured: Up to 3 months(BM sample); Up to 2 years(Blood sample)

  12. Pharmacokinetic (PK)- Cmax of CNCT19

    Maximum detected concentration of CNCT19 in peripheral blood

    Measured: Up to 2 years

  13. Pharmacokinetic (PK)- Tmax of CNCT19.

    Time to maximum concentration of CNCT19 in peripheral blood

    Measured: Up to 2 years

  14. Pharmacokinetic (PK)- AUC of CNCT19.

    Area under the concentration (AUC) vs time curve of CNCT19 in peripheral blood

    Measured: Up to 2 years

  15. Concentration of Cytokines in Serum

    Collected as pharmacodynamic data, including IL-6 at least

    Measured: 28 days

  16. Percentage of participants with anti-CNCT19 antibodies in serum

    To characterize prevalence and incidence of humoral immunogenicity to CNCT19

    Measured: 2 years

Timeline

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

  1. First posted28 Dec 2022
  2. Study start7 Feb 2023
  3. Primary completion30 May 2025
  4. Study completion30 May 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05667506
Sponsor's protocol ID
HY001103
Status last verified
Aug 2025
First submitted
5 Dec 2022
Last updated
12 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Currently the investigators have no plan of interim anaylsis, the investigators don't plan to share individual participant data(IPD) during the trial on-going.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing single dose of CNCT19 in people with B-cell Acute Lymphoblastic Leukemia, run by Juventas Cell Therapy Ltd. at 9 sites 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 7 inclusion and 14 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 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Hui Ding (+86-010-65960098, dinghui@juventas.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Remission Rate (ORR) (time frame: within 3 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 NCT05667506.

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 12 Aug 2025.

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