Clinical trial NCT05354362: A Study of ATG-010 in Combination With ATG-008 in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Official title: An Open Label, Phase Ⅰb Study of ATG-010 in Combination With ATG-008 in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Relapsed/Refractory Diffuse Large B-cell Lymphoma
Keywords: Lymphoma, Hodgkin's lymphoma , non-Hodgkin's lymphoma
Lead sponsor: Antengene Corporation
Sponsor class: INDUSTRY
First posted: 2022-04-29
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an Open label, Phase Ⅰb Study of ATG-010 in Combination With ATG-008 in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (RR DLBCL)

Detailed description: This is a multi-center, open label, phase 1 study conducted in RR DLBCL patients. The MTD and/or RP2D of study treatment, ATG-010 in combination with ATG-008, will be selected using BOIN design for the dose escalation phase. Additional patients will be enrolled as an expansion cohort after MTD and/or RP2D is determined.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old.
2. ECOG Performance score of ≤2.
3. Estimated life expectancy of \>3 months.
4. Previously treated, pathologically confirmed DLBCL
5. Patients must have received at least 2 but no more than 5 previous systemic regimens (for non-DH/TH, non-DE DLBCL and DLBCL not transformed from FL or CLL), or at least 1 but no more than 5 previous systemic regimens (for DH/TH, DE DLBCL, and DLBCL transformed from FL or CLL) for the treatment of their DLBCL.

   1. Prior stem cell transplantation is allowed; induction, consolidation, stem cell collection, preparative regimen and transplantation ± maintenance are considered a single line of therapy.
   2. Salvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of therapy.
   3. Any maintenance therapy will not be counted as a separate line of systemic therapy.
   4. Radiation with curative intent for localized DLBCL will not be counted as 1 line of therapy
6. Documented radiographic evidence of progressive DLBCL of the last line (or refractory DLBCL) prior to the first dosing.

Exclusion Criteria:

1. Female patients who are pregnant or lactating
2. DLBCL with mucosa-associated lymphoid tissue \[MALT\] lymphoma, or primary mediastinal (thymic) large B-cell lymphoma (PMBL)
3. Known central nervous system lymphoma or meningeal involvement (for dose expansion phase, patients with stable CNS disease could be considered).
4. Patients eligible for high-dose chemotherapy with autologous stem cell transplantation rescue (the Investigator must provide detailed documentation for ineligibility)
5. Use of any standard or experimental anti-DLBCL therapy (including radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) \<21 days prior to Cycle 1 Day 1.
6. Autologous stem cell transplant (SCT) \<6 months or prior allogeneic SCT, or CAR-T cell infusion \<6 months prior to Cycle 1.
7. Major surgery within 4 weeks of the first dose of study treatment.

Primary outcomes:
measure: MTD
timeFrame: the last patient on study has completed 12 months of follow-up
measure: RP2D
timeFrame: the last patient on study has completed 12 months of follow-up
Secondary outcomes:
measure: ORR
timeFrame: the last patient on study has completed 12 months of follow-up
measure: PFS
timeFrame: the last patient on study has completed 12 months of follow-up
measure: DOR
timeFrame: the last patient on study has completed 12 months of follow-up
measure: OS
timeFrame: the last patient on study has completed 12 months of follow-up
measure: TTR
timeFrame: the last patient on study has completed 12 months of follow-up
measure: TTP
timeFrame: the last patient on study has completed 12 months of follow-up
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Shenyang
country: China
facility: The first Affiliated Hospital of China medical University
state: Liaoning
Study officials:
affiliation: Medical Monitor
name: Yang Yu
role: STUDY_DIRECTOR
References: