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Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL)NCT07637929

Non-Interventional Study of Puzol-cel for CD19-Positive Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

An observational study of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL), run by Chongqing Precision Biotech Co., Ltd.

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

Establishing real-world data of Chinese patients with CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) treated with Puzolcabtagene Autoleucel Injection to evaluate its effectiveness. Read more about this study

Who is it for?
Any age
What is being tested?
Puzolcabtagene Autoleucel Injection
Type of treatment
Injection or infusion
How many people
200 participants
Where
No sites listed yet
Study dates
Jun 2026to Dec 2032
How long will I take part?
2 Years
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients diagnosed with CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL), regardless of gender.

Who may be able to join

  • Patients with r/r B-ALL who receive treatment with Pucicelant Injection at a research center commercially certified by Chongqing Precision Biotech in China, and whose bone marrow tumor cells are confirmed to express CD19 by flow cytometry
  • Patients with essentially normal function of vital organs
  • Patients who voluntarily participate in this study and sign the informed consent form. For patients under 18 years of age, informed consent must also be obtained from their legal guardians

Who cannot join

  • Patients who test positive for hepatitis C virus (HCV), human immunodeficiency virus (HIV), and Treponema pallidum (TP).

Trial locations and contacts

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

Jing Pan contact

010-63290606

panj@gobroadhealthcare.com

About this study

Official title: Non-Interventional Study of Puzolcabtagene Autoleucel Injection for CD19-Positive Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

Establishing real-world data of Chinese patients with CD19-positive relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) treated with Puzolcabtagene Autoleucel Injection to evaluate its effectiveness.

Read the detailed description

Best Overall Response (BOR), including CR and CRi(CR: Complete Remission; CRi: Complete Remission with incomplete hematologic recovery)、Best Complete Remission Rate (CRR)、MRD-negative Objective Response Rate (MRD: Minimal Residual Disease)、Duration of Response (DOR)、Relapse-Free Survival (RFS)、Overall Survival (OS)

Being tested
Puzolcabtagene Autoleucel Injection
Keywords
Puzolcabtagene Autoleucel Injection
Medical subject headings
Recurrence, Burkitt Lymphoma

What participants receive

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

  • Puzolcabtagene Autoleucel InjectionDrug

    An autologous T-cell suspension expressing the CD19 chimeric antigen receptor（CD19 CAR-T)

What is being measured

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

  1. Objective response rate after Puzol-cel infusion [Effectiveness]

    Objective response rate includes CR, CRi

    Measured: 2 year

Secondary outcomes (10)

  1. Minimal residual disease（MRD）

    MRD-negative ORR within 2 years by flow cytometry as assessed by investigator.

    Measured: 2 years

  2. Best overall response after Puzol-cel infusion [Effectiveness]

    Best overall response means the proportion of patients with the best efficacy (CR or CRi) after Puzol-cel therapy.

    Measured: 2 years

  3. Overall survival after Puzol-cel infusion [Effectiveness]

    Overall survival means the time from infusion of Puzol-cel to death of subjects from any cause

    Measured: 2 years

  4. Duration of response after Puzol-cel infusion [Effectiveness]

    Duration of response means the time from first assessment of CR or CRi to first assessment of disease recurrence or death from any cause, whichever occurs first

    Measured: 2 years

  5. Relapse free survival after Puzol-cel infusion [Effectiveness]

    Relapse free survival means time from subject infusion of Puzol-cel to first disease relapse or death from any cause (whichever occurs first)

    Measured: 2 years

  6. Event free survival after Puzol-cel infusion [Effectiveness]

    Event free survival means the time from the infusion of Puzol-cel to the time of the following events (whichever occurs first): a. Death from any cause after remission; b. Disease recurrence; c. Withdrawal from the clinical trial after treatment failure or meeting the withdrawal criteria.

    Measured: 2 years

  7. The incidence of Treatment Emergent Adverse Events (TEAE) of Puzol-cel

    Number of participants with adverse events as assessed by CTCAE v5.0

    Measured: 2 years

  8. the incidence of adverse events related to treatment of Puzol-cel infusion

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: 2 years

  9. the incidence of adverse event of special interest (AESI) of Puzol-cel infusion

    Number of participants with special interest adverse events as assessed by CTCAE v5.0,The following adverse events were defined as adverse events of special interest for this study: a.Cytokine release syndrome (CRS) of grade 3 and above; b. Immune effector cell-associated neurotoxicity syndrome (ICANS) of grade 3 and above; c.Grade 3 and above infection; d.Grade 3 and above acute tumor lysis syndrome; e.Unresolved cytopenias lasting 28 days.

    Measured: 2 years

  10. the incidence of RCL of Puzol-cel infusion

    RCL Detection: the incidence of Replication Competent Lentivirus.

    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 posted10 Jun 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionDec 2032 (estimated)
  4. Study completionDec 2032 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT07637929
Sponsor's protocol ID
PB14
Status last verified
Jun 2026
First submitted
22 May 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL), run by Chongqing Precision Biotech Co., Ltd.

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 1 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 10 Jun 2026. 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.

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 Jing Pan (010-63290606, panj@gobroadhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate after Puzol-cel infusion [Effectiveness] (time frame: 2 year). 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 NCT07637929.

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 Jun 2026.

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