NCT05147467 Study of APG-2575 in Patients With Relapsed/Refractory CLL/SLL
| NCT ID | NCT05147467 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ascentage Pharma Group Inc. |
| Condition | Chronic Lymphocytic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2021-12-28 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 75 participants in total. It began in 2021-12-28 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to assess the efficacy and safety of APG-2575 single agent in patients with relapsed/refractory CLL/SLL.
Eligibility Criteria
Inclusion Criteria: Subjects who meet each of the following inclusion criteria are eligible to participate in this study: 1. Age ≥18 years old. 2. Pathologically confirmed CLL/SLL according to the 2018 revised IWCLL NCI-WG guidelines, subject with measurable lesions or splenomegaly due to CLL. 3. Expected survival is at least 12 weeks. 4. Refractory, recurrent, or intolerant to BTK inhibitors and immunochemotherapy,or first-line treatment with BTK inhibitors fails and is not suitable for immunochemotherapy. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -2. 6. Ability to understand and willingness to sign a written informed consent form approved by EC committee (the consent form must be signed by the patient prior to any screening or study-specific procedures). 7. Willingness and ability to comply with study procedures and follow-up examination. Exclusion Criteria: Subjects who meet any of the following exclusion criteria are not to be enrolled in this study: 1. Prior history of allogeneic hematopoietic stem cell transplantation, adoptive cell immunotherapy or autologous hematopoietic stem cell transplantation within 24 months. 2. Failure to recover adequately, at the discretion of the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry. 3. Received Bcl-2 inhibitor treatment. 4. Invasive NHL transformation or central nervous system (CNS) involvement has occurred. 5. Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of treatment. 6. Within 2 years before entering the study, the subject had a history of active malignant tumors other than CLL / SLL, except that: * Fully treated cervical carcinoma in situ; * Completely resected basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; * Confinement and resection of previously cured malignancies (or other treatment). 7. Any other condition or circumstance that would, at the discretion of the investigator, make the patient unsuitable for participation in the study.
Contact & Investigator
Yifan Zhai, M.D., Ph.D.
STUDY DIRECTOR
Ascentage Pharma Group Inc.
Frequently Asked Questions
Who can join the NCT05147467 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Lymphocytic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05147467 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05147467 currently recruiting?
Yes, NCT05147467 is actively recruiting participants. Contact the research team at Zi.Chen@ascentage.com for enrollment information.
Where is the NCT05147467 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China, Guangzhou, China, Haikou, China and 7 additional locations.
Who is sponsoring the NCT05147467 clinical trial?
NCT05147467 is sponsored by Ascentage Pharma Group Inc.. The principal investigator is Yifan Zhai, M.D., Ph.D. at Ascentage Pharma Group Inc.. The trial plans to enroll 75 participants.
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