A Trial of SHR-A1912 Combined With Other Therapies in B-cell Non-Hodgkin 's Lymphoma

B-cell Non-Hodgkin's Lymphoma Clinical Trial

Official title:

A Phase Ib/II Study of SHR-A1912 Combined With Other Therapies in Patients With B-cell Non-Hodgkin 's Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06104553
• Other study ID #: SHR-A1912-II-201
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 17, 2023
• Est. completion date: June 2026

Study information

• Verified date: December 2023
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: Zhenyu Xiao, Medical Director
• Phone: 021-61053363
• Email: zhenyu.xiao.zx7[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• B-cell Non-Hodgkin's Lymphoma
• Lymphoma
• Lymphoma, B-Cell

Intervention

Drug:
• SHR-A1912; R-Chemo
SHR-A1912 combined with R-Chemo: SHR-A1912 + R-Chemo (Rituximab + Chemotherapy) (Phase 1b)
• SHR-A1912; R-Chemo
SHR-A1912 combined with R-Chemo: SHR-A1912 (RP2D) + R-Chemo (Rituximab + Chemotherapy) (Phase 2)

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1b: RP2D (Recommended Phase II Dose) of SHR-A1912 combined with immunochemotherapy		The RP2D for Phase 2 will be selected at the end of Phase 1b, approximately 12 months
Primary	Phase 1b: Incidence and severity of AE		Up to follow-up period, approximately 24 months]
Primary	Phase 2: Objective response rate		assessed up to approximately 24 months
Secondary	Phase 1b: Objective response rate		assessed up to approximately 24 months
Secondary	Phase 1b: Complete response rate (CRR)		assessed up to approximately 24 months
Secondary	Phase 1b: Duration of remission (DoR)		assessed up to approximately 24 months
Secondary	Phase 1b: Progression-free survival (PFS)		assessed up to approximately 24 months
Secondary	Phase 1b: Toxin binding antibody to SHR-A1912		Up to follow-up period, approximately 24 months
Secondary	Phase 1b: Total antibody to SHR-A1912		Up to follow-up period, approximately 24 months
Secondary	Phase 1b: Concentration of free toxin		Up to follow-up period, approximately 24 months
Secondary	Phase 1b: Anti-drug antibodies (ADA) to SHR-A1912		Up to follow-up period, approximately 24 months
Secondary	Phase 2: Complete response rate (CRR)		assessed up to approximately 24 months
Secondary	Phase 2: Duration of remission (DoR)		assessed up to approximately 24 months
Secondary	Phase 2: Progression-free survival (PFS)		assessed up to approximately 24 months
Secondary	Phase 2: Incidence and severity of AE		Up to follow-up period, approximately 24 months
Secondary	Phase 2: Toxin binding antibody to SHR-A1912		Up to follow-up period, approximately 24 months
Secondary	Phase 2: Total antibody to SHR-A1912		Up to follow-up period, approximately 24 months
Secondary	Phase 2: Concentration of free toxin		Up to follow-up period, approximately 24 months
Secondary	Phase 2: Anti-drug antibodies (ADA) to SHR-A1912		Up to follow-up period, approximately 24 months