B Cell Lymphoma
Conditions
Brief summary
To assess the safety and tolerability of SHR-A1912 in patients with B cell lymphoma, to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended phase II dose (RP2D) of SHR-A1912.
Interventions
DRUGSHR-A1912
SHR-A1912, dose escalation and expansion.
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single arm for SHR-A1912
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than or equal to18 years old, male or female; 2. Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1; 3. Life expectancy \>12 weeks; 4. Histologically or cytologically confirmed B cell lymphoma; 5. Relapsed and/or refractory disease after at least 1 prior treatment regimen; 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 (no need for dose escalation stage).
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events | 21 Days after the 1st dosing (first cycle) |
| Dose Limited Toxicity (DLT) | 21 Days (first cycle) |
| Maximum tolerable dose (MTD) | 21 Days (first cycle) |
| Recommended phase II dose (RP2D) | Up to approximately 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Time of maximum observed plasma concentration (Tmax) of SHR-1912 | 21 days after last dose |
| Maximum observed plasma concentration (Cmax) of SHR-1912 | 21 days after last dose |
| Area under the plasma concentration time curve (AUC) of SHR-1912 | 21 days after last dose |
| Disease Control Rate (DCR) | Up to approximately 2 years |
| Complete Response Rate (CR) | Up to approximately 2 years |
| Objective Response Rate (ORR) | Up to approximately 2 years |
| Duration of Response (DoR) | Up to approximately 2 years |
| Anti-drug antibody (ADA) of SHR-A1912 | 12 weeks after last dose |
| Progression-Free Survival (PFS) | Up to approximately 2 years |
| Overall Survival (OS) | Up to approximately 3 years |
| Adverse Events | 12 weeks after the last dose |
Countries
China
Outcome results
None listed