Status:
TERMINATED
A Study of ATG-010 in Combination With ATG-008 in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
Lead Sponsor:
Antengene Corporation
Conditions:
Relapsed/Refractory Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 th...
Eligibility Criteria
Inclusion
- Age ≥18 years old.
- ECOG Performance score of ≤2.
- Estimated life expectancy of \>3 months.
- Previously treated, pathologically confirmed DLBCL
- 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.
- Prior stem cell transplantation is allowed; induction, consolidation, stem cell collection, preparative regimen and transplantation ± maintenance are considered a single line of therapy.
- Salvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of therapy.
- Any maintenance therapy will not be counted as a separate line of systemic therapy.
- Radiation with curative intent for localized DLBCL will not be counted as 1 line of therapy
- Documented radiographic evidence of progressive DLBCL of the last line (or refractory DLBCL) prior to the first dosing.
Exclusion
- Female patients who are pregnant or lactating
- DLBCL with mucosa-associated lymphoid tissue \[MALT\] lymphoma, or primary mediastinal (thymic) large B-cell lymphoma (PMBL)
- Known central nervous system lymphoma or meningeal involvement (for dose expansion phase, patients with stable CNS disease could be considered).
- Patients eligible for high-dose chemotherapy with autologous stem cell transplantation rescue (the Investigator must provide detailed documentation for ineligibility)
- 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.
- Autologous stem cell transplant (SCT) \<6 months or prior allogeneic SCT, or CAR-T cell infusion \<6 months prior to Cycle 1.
- Major surgery within 4 weeks of the first dose of study treatment.
Key Trial Info
Start Date :
March 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05354362
Start Date
March 2 2022
End Date
February 8 2023
Last Update
March 17 2023
Active Locations (6)
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1
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
3
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510180
4
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079