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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL)
• Intervention / Treatment: Drug: Puzolcabtagene Autoleucel Injection

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)

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jing Pan; Phone Number: 010-63290606; Email: panj@gobroadhealthcare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate after Puzol-cel infusion [Effectiveness]	Objective response rate includes CR, CRi	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal residual disease（MRD）	MRD-negative ORR within 2 years by flow cytometry as assessed by investigator.	2 years
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.	2 years
Overall survival after Puzol-cel infusion [Effectiveness]	Overall survival means the time from infusion of Puzol-cel to death of subjects from any cause	2 years
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	2 years
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)	2 years
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.	2 years
The incidence of Treatment Emergent Adverse Events (TEAE) of Puzol-cel	Number of participants with adverse events as assessed by CTCAE v5.0	2 years
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	2 years
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.	2 years
the incidence of RCL of Puzol-cel infusion	RCL Detection: the incidence of Replication Competent Lentivirus.	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparative analysis of 6-month ORR of Puzol-cel treatment with or without hematopoietic stem cell transplantation	investigator-assessed ORR, including CR and CRi; investigator-assessed ORR with MRD-negative, including CR and CRi.	2 years
Assess the Children's growth and development after Puzol-cel infusion	The subject's height were measured before infusion and 1, 2, 3 months after infusion and every three months thereafter.	2 years

Collaborators and Investigators

• Sponsor: Chongqing Precision Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Puzolcabtagene Autoleucel Injection
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Infections; Virus Diseases; Neoplasms by Histologic Type; DNA Virus Infections; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Epstein-Barr Virus Infections; Herpesviridae Infections; Tumor Virus Infections; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Burkitt Lymphoma
• Other Study ID Numbers: PB14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No