Study of ZG005 in Combination With Gecacitinib in Patients With Relapsed or Refractory Lymphoma

ConditionLymphoma

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd

About this trial

PART 1:

1. To explore the safety of ZG005 in combination with Gecacitinib in patients with relapsed or refractory lymphoma. 2. To determine the recommended Phase II dosing regimen for relapsed or refractory lymphoma.

PART 2:

To evaluate the efficacy of ZG005 in combination with Gecacitinib in patients with relapsed or refractory lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fully understand this study and voluntarily sign the ICF；

Age ≥18 at ICF signing, regardless of gender；

Histologically confirmed relapsed or refractory lymphoma.

Disqualifiers

Lymphoma with known CNS involvement；

Severe cardiovascular/cerebrovascular diseases.

Any other reason deeming the participant unsuitable for the study, as judged by the investigator.

Trial design

Design model

Sequential

Treatments tested in this trial

ZG005 for Injection
Biological/Vaccine
intravenous infusion
Gecacitinib Hydrochloride Tablets
Drug
Oral

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Part 1: Plan AExperimental treatment 2 interventions

Group B: Part 1: Plan BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Objective response rate (ORR)

Time frame

Up to 2 years

Secondary outcomes

Immunogenicity

Incidence of antidrug antibodies (ADA)

Time frame

Up to 2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Lead sponsor

Source ClinicalTrials.gov

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