A Study of Evaluating the Safety and Efficacy of ATG-010 Combined With Chemotherapy Sequential With ATG-010 Monotherapy Maintenance in Peripheral T- and NK/T-cell Lymphoma

Phase 1

Active, not recruiting

• Conditions: NK/T-cell Lymphoma; Peripheral T-cell Lymphoma

• Registration Number: NCT04425070
• Lead Sponsor: Antengene Corporation

Brief Summary

This trial is proposed with treatment of ATG-010 combined with chemotherapy regimens which will be chosen by investigators (ICE \[ifosfamide+carboplatin+etoposide\] or GEMOX \[gemcitabine+oxaliplatin\] or Tislelizumab), after treatments of 2 to 6 cycles transferring to ATG-010 monotherapy maintenance treatment, to evaluate the safety, tolerability, and primary efficacy of ATG-010 in R/R PTCL and NK/T-cell lymphoma patients.

Detailed Description

This trial is an open-label, multi-center Phase Ib clinical study that will evaluate ATG-010 combined with chemotherapy regimen selected by investigators (ICE regimen ifosfamide+carboplatin+etoposide; Or GEMOX regimen: gemcitabine+oxaliplatin; Tislelizumab) sequential ATG 010 monotherapy maintenance, to evaluate the safety, tolerability, and primary efficacy in R/R PTCL and NK/T-cell lymphoma patients. 97 patients are planned to be enrolled.

Study Timeline

• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2020-08-18
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-04
• Last Update Posted: 2025-06-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. The patient is willing to provide written ICF.
2. Age≥ 18 years.
3. R/R PTCL and NK/T-cell lymphoma as confirmed by histological methods according to WHO classification of tumors of lymphoid tissues 2016.
4. Previously received at least one or more standard regimens including anthracycline.
5. Recurrence or the recurrence disease after the last treatment completed.
6. At least one measurable disease per modified efficacy assessment criteria (Cheson 2014).
7. ECOG PS 0 or 1.
8. Any toxicity caused by previously anti-tumor therapy must recovered to ≤ Grade 1 (NCI-CTCAE v5.0) with exception of hearing loss, alopecia, and pigmentation.
9. Expected life time longer than 3 months.

Exclusion Criteria

1. Current have disease or history of central nervous system lymphoma.
2. HBV-DNA positive, or HCV-RNA positive.
3. Patients with a known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome.
4. Received major surgery within 4 weeks of first dose of study drug
5. Known received SINE, including ATG-010.
6. Unable to swallow the tablets, suffers from malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may interfere with ATG-010 absorption.
7. Known allergy to ATG-010, or ICE, or GEMOX.
8. A woman who is pregnant or nursing.
9. The investigator considerations on patient's complications or other conditions may affect protocol compliance or may be inappropriate for participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	18 months	To determine the overall response rate according to Chenson 2014.
AEs/SAEs	18 months	Toxicity will be graded according to the NCI CTCAE, Version 5.0.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	18 months	Duration of time from the first dose of study drug until progression or death due to any cause
Disease control rate (DCR)	4 weeks to 18 months	Proportion of patients who achieve CR, PR, or SD for a minimum of 4 weeks, following the first dose of study drug (i.e., CR+PR+SD)
Duration of response (DOR)	18 months	Duration of time from first occurrence of CR or PR until the first date that disease progression is objectively documented.
Overall Survival (OS)	18 months	Duration of time from the first dose of study drug until death due to any cause

Trial Locations

Locations (13)

Anhui Provincial Cancer Hospital; 🇨🇳 Hefei, Anhui, China

Beijing Tongren Hospital.CMU; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Chongqing University Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital; 🇨🇳 Nanning, Guangxi, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Hubei Cancer Hospital; 🇨🇳 Wuhan, Hubei, China

Jiangsu Cancer Hospital; 🇨🇳 Nanjing, Jiangsu, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China

Scroll for more (3 remaining)