A Phase I/IIa, Open-label, Multicenter Study of the Safety and Efficacy of CHO-H01 As a Single Agent/Combined with Lenalidomide to Subjects with Refractory or Relapsed Non-Hodgkin's Lymphoma

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This is a 2-part study. Part 1/Phase 1 of the study will be conducted to determine the safety and tolerability of CHO-H01 in subjects with relapsed/refractory CD20+ non-Hodgkin's lymphoma. It will also determine maximum tolerated dose (MTD) and recommended phase II dose (RP2D). Part 2/Phase 2a will assess the anticancer activity and safety of CHO-H01 plus lenalidomide in subjects with low-grade relapsed/refractory CD20+ non-Hodgkin's lymphoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Life expectancy of \>12 weeks.

• Body mass index of 18 to 32 kg/m2.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

• Phase I: Have histologically (laboratory test) confirmed CD20 + non-Hodgkin's lymphoma according to the World Health Organization's 2016 classification:

‣ Low grade lymphoma: follicular lymphoma (Grades 1-3a), marginal zone lymphoma, small lymphocytic lymphoma;

⁃ Other lymphoma: DLBCL (NOS: to include germinal center B-cell-like \[GCB\] and activated B-cell-like \[ABC\]), follicular lymphoma Grade 3b, mantle cell lymphoma; primary mediastinal large B-cell lymphoma.

• Phase IIa: Histologically confirmed CD20 + non-Hodgkin's lymphoma according to the World Health Organization's 2016 classification, only low grade lymphoma: follicular lymphoma (Grades 1-3a), marginal zone lymphoma, small lymphocytic lymphoma.

• Have at least one measurable lesion that is at least 1.5 cm in its largest dimension.

• Off treatment for 30 days from last anti-CD20 infusion until planned administration of CHO-H01.

• If no original sample is available, is willing and able to provide an adequate tumor biopsy sample at Screening.

• Have adequate cardiac function: without clinically significant and/or uncontrolled heart disease.

• Must be sterile, or have a monogamous partner who is surgically sterile, or at least 2 years postmenopausal, or be committed to use an acceptable form of birth control for the duration of the study (male), and for the duration of the study and for 3 months following the last CHO-H01 administration (female).

Locations
United States
Texas
Renovatio Clinical
WITHDRAWN
The Woodlands
Other Locations
Taiwan
Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital - Hemato-Oncology
RECRUITING
Kaohsiung City
Taipei Medical University - Shuang Ho Hospital - Oncology
RECRUITING
New Taipei City
China Medical University Hospital - Hematology/Oncology - Taichung
RECRUITING
Taichung
National Cheng Kung University Hospital - Internal Medicine
RECRUITING
Tainan City
National Taiwan University Hospital - Hematology And Oncology
RECRUITING
Taipei
Tri-Service General Hospital - Neihu Branch - Hematology
RECRUITING
Taipei
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Hematology and Oncology - Hematology and Oncology
TERMINATED
Taoyuan District
Contact Information
Primary
Tanny Tsao
tanny.tsao@chopharma.com.tw
886226558059
Time Frame
Start Date: 2020-01-15
Estimated Completion Date: 2026-12-23
Participants
Target number of participants: 37
Treatments
Experimental: CHO-H01
Dose escalation phase~Phase 1:~Five to six cohorts of escalating dose levels of CHO-H01 from 0.5mg/kg to 12 mg/kg.
Experimental: CHO-H01+Lenalidomide
Expansion phase with lenalidomide combination.~Phase2a:~Single cohort at Recommended Phase 2 Dose (RP2D) of CHO-H01.
Related Therapeutic Areas
Sponsors
Leads: Cho Pharma Inc.

This content was sourced from clinicaltrials.gov