A Clinical Study of SHR-3079 in B-cell Non-Hodgkin Lymphoma
ConditionB-cell Non-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.
About this trial
The study is being conducted to evaluate the safety and tolerability of SHR-3079, and to explore the Dose-limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of SHR-3079 in patients with B-cell non-Hodgkin lymphoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥ 18 years old;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, expected survival ≥ 3 months;
Histologically confirmed B-NHL;
Participant population: Have received ≥ 1 line of standard anti-tumor treatment, and have not achieved response after the latest treatment or have progressive disease after the treatment;
Disqualifiers
Central nervous system (CNS) infiltration;
Prior chemotherapy or other anti-lymphoma agents administered within 4 weeks before the first dose of study treatment;
Major surgery within 4 weeks before signing the ICF, or plan to undergo major surgery during the study period;
Receipt of CAR-T therapy or autologous stem cell transplant within 12 weeks prior to enrollment;
Trial design
Design model
Single group
Treatments tested in this trial
SHR-3079 Injection
DrugSHR-3079 injection.
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: SHR-3079 GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting Toxicity (DLT)
Time frame
28 days after treatment initiation.2
Maximum tolerated dose (MTD)
Time frame
Approximately 1 year.3
Recommended Phase II Dose (RP2D)
Time frame
Approximately 1 year.Secondary outcomes
1
Types, incidence and severity of Adverse events (AEs)
Safety endpoints.
Time frame
Approximately 1 year.2
Serious adverse events (SAEs)
Safety endpoints.
Time frame
Approximately 1 year.3
Peak concentration (Cmax)
Pharmacokinetics (PK) Parameters.
Time frame
Approximately 1 year.4
Time to peak concentration (Tmax)
Pharmacokinetics (PK) Parameters.
Time frame
Approximately 1 year.Sponsors and contacts
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Source ClinicalTrials.gov