ALL (Acute B-Lymphoblastic Leukemia)NCT07269587

A Real-world Study on the Treatment of Adult B-cell Acute Lymphoblastic Leukemia With CNCT-19

An observational study of ALL (Acute B-Lymphoblastic Leukemia) and CAR-T Cell Therapy, run by Ruijin Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This clinical study is a retrospective, observational, and multicenter post marketing real-world study aimed at evaluating the efficacy and safety of CNCT-19 in the treatment of Chinese adult B-cell acute lymphoblastic leukemia patients. Read more about this study

Who is it for?: Ages 14 years and older
Conditions the study is for: ALL (Acute B-Lymphoblastic Leukemia), CAR-T Cell Therapy
What is being tested?: CNCT-19
How many people: 275 participants
Where: 1 siteChina
Study dates: 7 Nov 2025to 30 Nov 2027
Phase: Observational
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 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients received CNCT-19 treatment in all participant center of this study

Who may be able to join

Age ≥ 14 years old;
Diagnosed with CD19+B-cell acute lymphoblastic leukemia [refer to the Chinese Guidelines for Diagnosis and Treatment of Adult Acute lymphoblastic Leukemia (2024 edition)];
Patients who have received treatment with CNCT-19.

Who cannot join

Individuals with acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within the first 4 weeks of screening; Individuals who have received systemic drug therapy for GVHD within the past 4 weeks prior to reinfusion;
Active systemic autoimmune diseases during treatment;
Those who meet any of the following criteria:
Positive hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg);
hepatitis B e antibody (HBe Ab) and/or hepatitis B core antibody (HBc Ab) are positive, and the number of HBV-DNA copies is greater than the measurable lower limit;
Hepatitis C antibody (HCV Ab) positive;

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Positive for Treponema pallidum antibody (TP Ab);
Positive human immunodeficiency virus (HIV) antibody test;
EBV-DNA and CMV-DNA copy numbers are greater than the measurable lower limit;
Individuals known to have a history of hypersensitivity reactions to the components of the formulation used in the experiment.

Trial locations and contacts

1 site in 1 country.

China1 site

Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

Official title: A Retrospective, Observational, and Multicenter Real-world Study on the Treatment of Adult B-cell Acute Lymphoblastic Leukemia With CNCT-19

Conditions: ALL (Acute B-Lymphoblastic Leukemia), CAR-T Cell Therapy
Being tested: CNCT-19

What participants receive

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

CNCT-19Drug
All patients have received CNCT-19

Study groups in NCT07269587
Study group	Role	What they receive
observation group		Not described Receives: Drug: CNCT-19

What is being measured

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

overall response rate(for R/R patients)
The proportion of patients who reach CR/CRi.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 24 months
minimal residual disease negativity rate(for MRD positive patients)
The proportion of patients who reach MRD negative in all patients reached CR/CRi.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 24 months

Secondary outcomes (6)

DOR(Duration Of Remission)
Time from the first assessment of MRD negative to the first assessment of MRD positive or death from any cause.
Measured: till the end of the study, up to 24 months
rate of Allogeneic hematopoietic stem cell transplantation
The proportion of patients who receive allo-HSCT after CNCT19 treatment.
Measured: till the end of the study, up to 24 months
Relapse-free survival (RFS)
Interval from the date of treatment of the CNCT-19 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 24 months
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 24 months
incidence of Adverse Events(AEs)
The proportion of patients who have adverse events after CNCT-19 treatment.Adverse events will be assessed by CTCAE v5.0
Measured: up to 24 months
incidence of Severe Adverse Events(SAEs)
The proportion of patients who have severe adverse events after CNCT-19 treatment.Adverse events with one of the following damages should be classified as serious drug adverse events:
1. Causing death;
2. Endangering life;
3. Causing hospitalization or prolonged hospitalization time;
4. Causing permanent or significant disability/loss of function;
5. Congenital abnormalities/birth defects;
6. Causing other important medical events that, if left untreated, may result in the situations listed above.
Measured: up to 24 months

Timeline

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

7 Nov 202530 Nov 2027

First posted8 Dec 2025
Study start7 Nov 2025
Primary completion30 Nov 2027 (estimated)
Study completion30 Nov 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ALL (Acute B-Lymphoblastic Leukemia)Studies of the same condition, open and under way.
More trials run by Ruijin HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Observational
Observational model: Other
Time perspective: Retrospective
Enrolment: 275 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07269587
Sponsor's protocol ID: CN-ALL RWS001
Status last verified: Dec 2025
First submitted: 25 Nov 2025
Last updated: 10 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Retrospective, Observational, and Multicenter Real-world Study on the Treatment of Adult B-cell Acute Lymphoblastic Leukemia With CNCT-19
ClinicalTrials.gov ID: NCT07269587
Acronym / sponsor ID: CN-ALL RWS001
Conditions: ALL (Acute B-Lymphoblastic Leukemia), CAR-T Cell Therapy
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 275 participants (actual)
Lead sponsor: Ruijin HospitalUniversity, hospital or other
Study start: 7 Nov 2025 (actual)
Primary completion: 30 Nov 2027 (estimated)
Study completion: 30 Nov 2027 (estimated)
First posted: 8 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
observation group	–	Drug: CNCT-19

Who may qualify

Ages: 14 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients received CNCT-19 treatment in all participant center of this study

Key inclusion criteria (3 listed)

Age ≥ 14 years old;
Diagnosed with CD19+B-cell acute lymphoblastic leukemia [refer to the Chinese Guidelines for Diagnosis and Treatment of Adult Acute lymphoblastic Leukemia (2024 edition)];
Patients who have received treatment with CNCT-19.

Key exclusion criteria (10 listed)

Individuals with acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within the first 4 weeks of screening; Individuals who have received systemic drug therapy for GVHD within the past 4 weeks prior to reinfusion;
Active systemic autoimmune diseases during treatment;
Those who meet any of the following criteria:
Individuals known to have a history of hypersensitivity reactions to the components of the formulation used in the experiment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CNCT-19All patients have received CNCT-19	Drug	observation group

Primary outcome

overall response rate(for R/R patients)
Time frame: Till the end of the study, up to 24 months
The proportion of patients who reach CR/CRi.Bone marrow of every patient will be analysed by multiparameter flow cytometry or/and RT-qPCR for MRD evaluation.
minimal residual disease negativity rate(for MRD positive patients)
Time frame: Till the end of the study, up to 24 months
The proportion of patients who reach MRD negative in all patients reached CR/CRi.Bone marrow of every patient will be analysed by multiparameter flow cytometry or/and RT-qPCR for MRD evaluation.

6 secondary outcomes

DOR(Duration Of Remission)
Time frame: till the end of the study, up to 24 months
rate of Allogeneic hematopoietic stem cell transplantation
Time frame: till the end of the study, up to 24 months
Relapse-free survival (RFS)
Time frame: till the end of the study, up to 24 months
Overall Survival(OS)
Time frame: till the end of the study, up to 24 months
incidence of Adverse Events(AEs)
Time frame: up to 24 months
incidence of Severe Adverse Events(SAEs)
Time frame: up to 24 months

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of ALL (Acute B-Lymphoblastic Leukemia) and CAR-T Cell Therapy, 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 3 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 10 Dec 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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall response rate(for R/R patients) (time frame: Till the end of the study, up to 24 months). The study lists 2 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 NCT07269587.

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 10 Dec 2025.