A Study of APG-3288 in Relapsed/Refractory Blood Cancers

Conditions

• Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL
• Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL; Including Richter Transformation)
• Relapsed/Refractory Follicular Lymphoma (FL)
• Relapsed/Refractory Hematological Malignancies
• Relapsed/Refractory Mantle Cell Lymphoma (MCL)
• Relapsed/Refractory Marginal Zone Lymphoma (MZL)
• Relapsed/Refractory Waldenström Macroglobulinemia (WM)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• APG-3288 — DRUG
  Orally administered daily; 28 days per cycle.

Study Details

This is a Phase I, multicenter, open-label, two-stage study of APG-3288 monotherapy, aiming to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of APG-3288 administered orally once daily in patients with relapsed/refractory (R/R) hematologic malignancies.

Key Dates

First listed

Feb 20, 2026

Start date

Aug 31, 2026

Status verified

Jul 2026

Primary completion

Dec 31, 2029

Completion

Dec 31, 2031

Study Design

Enrollment

180 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1 (Dose Escalation Phase)
  APG-3288 at multiple dose levels will be evaluated to determine the recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD).
• Experimental: Part 2 (Dose Expansion Phase)
  Indications and dose cohorts to be determined from Part 1

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) at each dose level [ Time Frame: From first dose through the end of Cycle 1 (e.g., Day 1 to Day 28) ]

Central Contacts

• Yifan Zhai, M.D., Ph.D.
  18998334688
  [email protected]
• Qiwei Chen, M.D.
  [email protected]

Locations (5)

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