A Study to Evaluate ICP-022 in Patients With R/R PCNSL and SCNSL

  • STATUS
    Recruiting
  • participants needed
    39
  • sponsor
    Beijing InnoCare Pharma Tech Co., Ltd.
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Updated on 19 February 2024
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lymphoma
b-cell lymphoma
diffuse large b-cell lymphoma
primary cns lymphoma

Summary

The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.

Description

Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with Recurrent/Refractory Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL) will be evaluated in approximately 39 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects .

Details
Condition PCNSL, Secondary Central Nervous System Lymphoma
Age 18years - 75years
Treatment ICP-022
Clinical Study IdentifierNCT04438044
SponsorBeijing InnoCare Pharma Tech Co., Ltd.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Men and women 18, and 75 years of age
Histologically documented PCNSL, or histologically documented systemic diffuse large B-cell lymphoma (DLBCL) for SCNSL
Subjects with refractory or relapsed disease, one prior CNS directed therapy, and 4 systemic treatments
ECOG performance status of 0-2
Able to provide signed written informed consent

Exclusion Criteria

Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded
T-cell lymphoma
Patient requires more than 8 mg of dexamethasone daily or the equivalent
Non-hematological toxicity must recover to Grade 1 from prior anti-cancer therapy (except for alopecia)
Known active infection with HBV, HCV or HIV
Note: Other protocol defined Inclusion/Exclusion criteria may apply
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