Single-arm, Open-label, Dose-escalating Phase I Clinical Study of PA3-17 Injection in Children an… (NCT07623681) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Single-arm, Open-label, Dose-escalating Phase I Clinical Study of PA3-17 Injection in Children and Adolescents With Relapsed/Refractory T-lymphoblastic Leukemia/Lymphoma
China12 participantsStarted 2026-06-10
Plain-language summary
This is a phase I, open-label, dose-escalation clinical trial. The primary objectives are to assess the safety of PA3-17 injection in pediatric and adolescent participants with relapsed/refractory T-lymphoblastic leukemia/lymphoma, and determine the recommended phase II dose of PA3-17 injection for this patient population.
Secondary objectives include evaluating the pharmacokinetics/pharmacodynamics, preliminarily assessing clinical efficacy, and evaluating the immunogenicity of the injection.
Who can participate
Age range
3 Years – 18 Years
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:
* (1) Aged from 3 to 18 years (inclusive), with no restriction on gender. (2) Expected survival time ≥ 3 months. (3) At screening, Karnofsky Performance Status score (for subjects aged ≥ 16 years) or Lansky Performance Score (for subjects aged \< 16 years) \> 60 points (see Appendix 4).
(4) Diagnosed with T-ALL or T-LBL (including ETP-ALL and ETP-LBL) by local laboratories based on the classification criteria of WHO Classification of Haematolymphoid Tumours, 5th Edition: Lymphoid Neoplasms, confirmed via MICM classification (morphology, immunology, cytogenetics and molecular genetics), and/or pathological and imaging examinations.
For subjects diagnosed with T-LBL: bone marrow smear shows blasts between 5% (inclusive) and 20% (exclusive), or focal infiltration is observed on bone marrow biopsy indicating bone marrow involvement of T-LBL.
(5) Subjects with relapsed or refractory disease after failure of standard treatment or without available effective treatment options:
① Refractory disease: Failure to achieve remission after completion of at least 2 cycles of standard induction chemotherapy\*.
② Relapsed disease: New extramedullary lesions or bone marrow recurrence occurring in subjects who have achieved complete remission (CR).
Early relapse (\< 12 months) after complete remission; Late relapse (≥ 12 months) after complete remission with no response to one cycle of standard induction chemotherapy\*.
Definition of bone marrow recurrence: If the …
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.