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

NCT07637929 | Not Yet Recruiting DMC

• 1 other identifier: PB14
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

Puzolcabtagene Autoleucel Injection

Outcome Measures

Primary Outcomes (1)

• Objective response rate after Puzol-cel infusion [Effectiveness]

  Objective response rate includes CR, CRi

  2 year

Secondary Outcomes (10)

• Minimal residual disease（MRD）

  2 years

• Best overall response after Puzol-cel infusion [Effectiveness]

  2 years

• Overall survival after Puzol-cel infusion [Effectiveness]

  2 years

• Duration of response after Puzol-cel infusion [Effectiveness]

  2 years

• Relapse free survival after Puzol-cel infusion [Effectiveness]

  2 years

Other Outcomes (2)

• Comparative analysis of 6-month ORR of Puzol-cel treatment with or without hematopoietic stem cell transplantation

  2 years

• Assess the Children's growth and development after Puzol-cel infusion

  2 years

Interventions

Puzolcabtagene Autoleucel Injection DRUG

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Chongqing Precision Biotech Co., Ltd: lead

Biospecimen

Retention: SAMPLES WITH DNA

bone marrow samples, peripheral blood samples, cerebrospinal fluid samples

MeSH Terms

Conditions

Recurrence; Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Jing Pan

CONTACT

010-63290606; panj@gobroadhealthcare.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share