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

ConditionB-cell Non-Hodgkin's Lymphoma

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age greater than or equal to18 years old;

Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 1;

Life expectancy >3 months;

Histologically confirmed B-cell B-cell non-Hodgkin's lymphoma;

Disqualifiers

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;

History of recent major surgery or severe trauma within 4 weeks before the first study treatment;

Received anti-tumour treatment within 2 weeks before the first study treatment;

Central nervous system (CNS) infiltration;

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

132 Participants

are divided into 2 treatment groups

Group A: SHR-A1912 combined with R-Chemo (Phase 1b)Experimental treatment 1 intervention

Group B: SHR-A1912 combined with R-Chemo (Phase 2)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Phase 1b: RP2D (Recommended Phase II Dose) of SHR-A1912 combined with immunochemotherapy

Time frame

The RP2D for Phase 2 will be selected at the end of Phase 1b, approximately 12 months

Phase 1b: Incidence and severity of AE

Time frame

Up to follow-up period, approximately 24 months]

Phase 2: Objective response rate

Time frame