This study is a multi-center, open, single-arm phase I/II clinical study to evaluate the
recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection in Chinese
patients with relapsed/refractory lymphoma .
The study is comprised of two parts: phase I is the dose escalation part, and phase II is the
efficacy exploratory part and the efficacy confirmation part.
Phase I dose escalation part: it is planned to recruit patients with relapsed/refractory
lymphoma.Four dose groups : 7.5 mg/kg, 15 mg/kg, 22.5 mg/kg and 30 mg/kg ,will be explored
according to the 3+3" principle. First, 3 subjects were enrolled. If no DLT occur during the
DLT observation period, the next dose group test was conducted;if DLT occurs in 2 or more of
the 3 patients in this group, the climbing will be terminated or a lower dose group shall be
recommended by the Safety Review Committee ; if DLT occurs in only 1 of the 3 patients, add 3
patient, if 3 patients did not develop DLT, the dose is escalated to the next group; if DLT
occurs in 1 or more of the three additional patients, the dose escalation will be terminated
or the Safety Review Committee recommends a new lower dose group. Safety Review Committee
will be based on the safety and tolerability of every dose group and PK(pharmacokinetics) and
PD (pharmacodynamics) data, for the next dose increasing amplitude and dosing cycle are
discussed, at the same time also will recommend whether to increase the dose of unplanned
group or dosing method and dosing cycle of exploration group.
phase II is the efficacy exploratory part and the efficacy confirmation part. : 5 cohorts
will be carried out in parallel to initially evaluate the effectiveness of recombinant
humanized anti-CD47/PD-1 bifunctional antibody HX009 injection.
The 5 cohorts in the efficacy exploration part are:
Cohort 1: Relapsed/refractory diffuse large B-cell lymphoma; Cohort 2: Relapsed/refractory
peripheral T-cell lymphoma; Cohort 3: Relapsed/refractory classic Hodgkin's lymphoma; Cohort
4: Relapsed/refractory mantle cell lymphoma; Cohort 5: Relapsed/refractory follicular
lymphoma and marginal zone lymphoma; In the efficacy exploration part, each cohort will
enroll 15 subjects, a total of 5 cohorts, and 75 patients are expected to be enrolled.
According to the analysis of the Safety Review Committee , the cohort with the efficacy
enters the efficacy confirmation part, and the number of subjects in the efficacy
confirmation part is re-estimated according to statistics; the cohort without the efficacy
trend is enrolled up to 15 patients (according to the analysis of the Safety Review Committee
, the group can be stopped midway).
In the second phase of efficacy confirmation , one or two indications with better safety and
efficacy among the 5 cohorts in the efficacy exploration part will be selected to further
confirm the efficacy of recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009
injection And safety.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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