This is a two-phase, open-label Phase Ib clinical trial to evaluate the safety and efficacy of TQB2618 injection combined with Penpulimab in patients with relapsed and refractory lymphoma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
92
TQB2618 injection is an inhibitor of T cell immunoglobulin and mucin domain-containing protein 3 (TIM3)
Penpulimab is an inhibitor of programmed cell death protein 1 (PD-1)
Sichuan Cancer Hospital
Chengdu, Sichuan, China
RECRUITINGdose limiting toxicity/DLT
The relevant adverse reactions occurred within the first cycle
Time frame: From the first injection up to 3 weeks
recommended phase II dose/RP2D
The dose of TQB2618 injection which is recommended to use during phase II clinical trial
Time frame: From the first injection up to 6 weeks
Overall response rate (ORR) based on 2014 Lugano
Percentage of participants achieving complete response (CR) and partial response (PR).
Time frame: From the first injection up to 96 weeks
complete remission rate/CRR
Percentage of participants achieving complete response
Time frame: From the first injection up to 96 weeks
Disease control rate/DCR
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: From the first injection up to 96 weeks
Duration of Response (DOR)
The time when the participants first achieved CR or PR to disease progression or death from any cause.
Time frame: From the first injection up to 120 weeks
Progression-free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause. cause. cause. PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Time frame: Up to 96 weeks
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Overall survival/OS
OS defined as the time from randomization until the death from any cause
Time frame: From date of randomization until the death from any cause, assessed up to 120 weeks
Peak time/Tmax
The time to peak concentration
Time frame: Cycle 1 day 1 Before administration, 30 minuets,4,8,24,48,144,312 hours after minuets, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1, Cycle 5 day 1, Cycle 6 day 1, Cycle 7 day 1, Cycle 8 day 1 before and 30 minutes after administration.each cycle 21 days
Peak concentration (Cmax)
Maximum plasma drug concentration
Time frame: Cycle 1 day 1 Before administration, 30 minuets,4,8,24,48,144,312 hours after minuets, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1, Cycle 5 day 1, Cycle 6 day 1, Cycle 7 day 1, Cycle 8 day 1 before and 30 minutes after administration.(each cycle 21 days)
Half-life /T1/2
The time it takes for the drug's concentration in the body to drop by half
Time frame: Cycle 1 day 1 Before administration, 30 minuets,4,8,24,48,144,312 hours after minuets, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1, Cycle 5 day 1, Cycle 6 day 1, Cycle 7 day 1, Cycle 8 day 1 before and 30 minutes after administration.(each cycle 21 days)
Receptor Occupancy/RO
The extent to which antibody drugs occupy cell surface targets
Time frame: Cycle 1 day 1, Cycle 2 day 1, Cycle 3 day 1, Cycle 4 day 1, Cycle 5 day 1, Cycle 6 day 1, Cycle 7 day 1, Cycle 8 day 1 before administration and 30 minutes after administration and the day of disease progression(each cycle 21 days)
Incidence of Anti-Drug antibody and neutralizing antibodies
The incidence of anti-drug antibody and neutralizing antibodies after administration of TQB2618 and penpulimab
Time frame: Cycle 1 day 1, Cycle 2 day 1, Cycle 4 day 1, Cycle 8 day 1,before administration and 30, 90 days after the last administration(each cycle 21 days)
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time frame: Baseline up to 96 weeks