A Study of ATG-010 in Combination With Lenalidomide and Rituximab (R2) in Adults With DLBCL and iNHL

Sponsor
Antengene Corporation
Study ID
NCT05265975
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • ATG-010 — DRUG
    Tablets,20mg, once a week: dosage group 1:40mg/time, dosage group 2:60mg/time, dosage group 3:80mg/time The treatment period was 28 days. The drug was administered on day 1,8 and 15 of each cycle
  • Lenalidomide — DRUG
    Oral administration,QD, Days 1-21 of each cycle
  • Rituximab — DRUG
    Intravenous injection Days 1 of each cycle, Cycles 1-6

Study Details

A Single-arm, Phase Ⅰ/Ⅱ Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of ATG-010 in Combination with Lenalidomide and Rituximab (R2) in Adult Patients with Relapsed/Refractory DLBCL and iNHL Who are Ineligible for High-dose Chemotherapy (HDC) or Autologous Stem Cell Transplant (A SCT).

Key Dates

Start date
Apr 7, 2022
Status verified
Mar 2025
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
54 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ATG-010
    Enrolled patients will be treated with dosage groups. Dosage group 1:40mg/time, dosage group 2:60mg/time, dosage group 3:80mg/time; The treatment period was 28 days. The drug was administered on day 1,8 and 15 of each cycle

Primary Outcome Measure

DLT [ Time Frame: 28 days after administration ]

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