Clinical trial · Observational
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
NCT07637929CI-TRIAL-00114303not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (r/r B-ALL) | Burkitt Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Puzolcabtagene Autoleucel Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Objective response rate after Puzol-cel infusion [Effectiveness]
- timeFrame
- 2 year
- description
- Objective response rate includes CR, CRi
Secondary outcomes (10)
- measure
- Minimal residual disease（MRD）
- timeFrame
- 2 years
- description
- MRD-negative ORR within 2 years by flow cytometry as assessed by investigator.
- measure
- Best overall response after Puzol-cel infusion [Effectiveness]
- timeFrame
- 2 years
- description
- Best overall response means the proportion of patients with the best efficacy (CR or CRi) after Puzol-cel therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.