Non-Interventional Study of Puzol-cel for CD19-Positive Relapsed/Refractory B-Cell Acute Lymphobl… (NCT07637929) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Non-Interventional Study of Puzol-cel for CD19-Positive Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
200 participantsStarted 2026-06
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is listed as 'not yet recruiting,' how long might it realistically be before I could even be considered for enrollment, and would waiting potentially affect my treatment options in the meantime?
2This is described as a non-interventional study measuring how well Puzol-cel works in real-world use — does that mean patients in this study would already be receiving Puzol-cel as part of their standard care, or would participating change anything about my treatment plan?
3Because this trial focuses specifically on CD19-positive B-cell ALL that has relapsed or is refractory to prior treatment, can you tell me whether my leukemia has been confirmed CD19-positive, and what that means for which treatments might work for me?
4This study is measuring objective response rate after Puzol-cel infusion — are there other CAR-T or similar cell therapies already approved for relapsed or refractory B-cell ALL that have established response rate data I should consider comparing to this one?
5Since this trial has no listed phase, which suggests it may be observational rather than a traditional interventional study, what would be the difference in terms of risk and potential benefit for me compared to joining a Phase 1 or Phase 2 interventional trial for my condition?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate after Puzol-cel infusion [Effectiveness]