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OncoMatch/Clinical Trials/NCT04494503

Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed/Refractory CLL/SLL

Is NCT04494503 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including APG-2575 and Rituximab for chronic lymphocytic leukemia.

Phase 1/2RecruitingAscentage Pharma Group Inc.NCT04494503Data as of Jun 2026Location: China

Treatment: APG-2575 · Rituximab · IbrutinibThe purpose of this study is to assess the safety, pharmacokinetic, pharmacodynamic and efficacy of APG-2575 single agent and in combination with other therapeutic agents in patients with relapsed/refractory CLL/SLL.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Rituximab

Targeted therapy

Ibrutinib

Other

APG-2575

Cancer type

Chronic Lymphocytic Leukemia

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: allogeneic hematopoietic stem cell transplantation

Exception: within 24 months

Prior history of allogeneic hematopoietic stem cell transplantation, adoptive cell immunotherapy within 24 months

Cannot have received: autologous hematopoietic stem cell transplantation

Exception: within 12 months

autologous hematopoietic stem cell transplantation within 12 months

Cannot have received: adoptive cell immunotherapy

Exception: within 24 months

adoptive cell immunotherapy within 24 months

Cannot have received: monoclonal antibody therapy against CLL

Exception: within 4 weeks prior to the first dose of the study drug

Monoclonal antibody therapy against CLL was adopted within 4 weeks prior to the first dose of the study drug.

Cannot have received: anti-tumor therapies (chemotherapy, radiotherapy, anti-tumor steroid treatment, anti-tumor Chinese medicine treatment)

Exception: within 14 days or 5x half-life before the first dose of study drug

Receive any of the following treatments within 14 days or 5x half-life before the first dose of study drug, or clinically significant adverse reactions / toxicities due to previous treatments have not recovered to ≤ Grade 1: Anti-tumor therapies include chemotherapy, radiotherapy, anti-tumor steroid treatment, anti-tumor Chinese medicine treatment

Cannot have received: investigational treatment (including targeted small molecule drugs)

Exception: within 14 days or 5x half-life before the first dose of study drug

investigational treatment, including targeted small molecule drugs

Cannot have received: BCL2 inhibitor

Received Bcl-2 inhibitor treatment.

Lab requirements

Blood counts

Adequate bone marrow function independent of growth factor and transfusion

Kidney function

Adequate renal function

Liver function

Adequate liver function

Cardiac function

QTcF interval ≤450ms in males, and ≤470ms in females; Cardiovascular disease of grade ≥2 (New York Heart Association Class) excluded

QTcF interval ≤450ms in males, and ≤470ms in females. Adequate bone marrow function independent of growth factor and transfusion. Adequate renal and liver function. Cardiovascular disease of grade ≥2 (New York Heart Association Class) excluded.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT04494503 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior allogeneic hematopoietic stem cell transplantation, autologous hematopoietic stem cell transplantation, adoptive cell immunotherapy disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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