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Trial Title:
A Trial of SHR-A1912 Combined With Other Therapies in B-cell Non-Hodgkin 's Lymphoma
NCT ID:
NCT06104553
Condition:
B-cell Non-Hodgkin's Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
An open, multicenter, dose-finding and dose expansion investigational Phase Ib/II
clinical trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1912; R-Chemo
Description:
SHR-A1912 combined with R-Chemo: SHR-A1912 + R-Chemo (Rituximab + Chemotherapy) (Phase
1b)
Arm group label:
SHR-A1912 combined with R-Chemo (Phase 1b)
Intervention type:
Drug
Intervention name:
SHR-A1912; R-Chemo
Description:
SHR-A1912 combined with R-Chemo: SHR-A1912 (RP2D) + R-Chemo (Rituximab + Chemotherapy)
(Phase 2)
Arm group label:
SHR-A1912 combined with R-Chemo (Phase 2)
Summary:
This study aims to evaluate the safety, PK and preliminary anti-tumour activity of
SHR-A1912 combined with other therapies in patients with B-cell non-Hodgkin 's lymphoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age greater than or equal to18 years old;
2. Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1;
3. Life expectancy >3 months;
4. Histologically confirmed B-cell B-cell non-Hodgkin's lymphoma;
5. Previous systematic anti-tumor therapy should meet the following requirements: 1)
Relapsed and/or refractory disease after at least one (≥ 1) line of prior systemic
therapy (relapsed/refractory cohort); 2) Previously untreated (naïve cohort).
6. At least one measurable nodal lesion, defined as > 1.5 cm in its longest dimension,
or one measurable extra nodal lesion, defined as > 1.0 cm in its longest diameter.
Exclusion Criteria:
1. Received autologous stem cell transplantation within 12 weeks before the first study
treatment; previously received allogeneic stem cell transplantation; received Car-T
cell therapy within 12 weeks before the first study treatment;
2. History of recent major surgery or severe trauma within 4 weeks before the first
study treatment;
3. Received anti-tumour treatment within 2 weeks before the first study treatment;
4. Central nervous system (CNS) infiltration;
5. Active infection with HBV or HCV;
6. History of immunodeficiency, including HIV serotest positive, or other acquired or
congenital immunodeficiency diseases, and active tuberculosis;
7. Active infection or unexplained fever>38.5℃;
8. History of severe cardiovascular disease.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuqin Song, Doctor
Phone:
+86-13683398726
Email:
songyuqin622@163.com
Start date:
November 17, 2023
Completion date:
June 2026
Lead sponsor:
Agency:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06104553
