A Study to Assess Safety and Efficacy of CHO-H01 As a Single Agent/Combined with Lenalidomide in Subjects with Refractory or Relapsed Non-Hodgkin's Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2026-12-23

Brief Summary

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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.

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Detailed Description

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Phase I FIH study includes subjects with relapsed/refractory CD20 + non-Hodgkin's lymphoma, who may benefit from treatment with CHO-H01. In Phase I of the study, the first 2 cohorts will follow a 2-step modified accelerated titration dose escalation design and subsequent cohorts will follow a standard 3+3 dose escalation design.

The investigational medicinal product, CHO-H01, will be administered via IV infusion once weekly for 4 weeks in Cycle 1 and then once only (on Day 1) in each subsequent 21-day cycle until disease progression or for up to 6 cycles (19 weeks) of treatment.

Once the MTD/RP2D has been confirmed, Phase IIa of the study will be initiated. The purpose of Phase IIa is to assess anticancer activity and safety of CHO-H01 plus lenalidomide in low-grade relapsed/refractory CD20 + non Hodgkin's lymphoma, including follicular lymphoma (Grades 1-3a), marginal zone lymphoma, and small lymphocytic lymphoma.

Conditions

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Non-Hodgkin Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

3+3 sequential cohort design

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CHO-H01

Intervention Type DRUG

Phase 1:

Subjects will be administered intravenous (IV) infusion of assigned dose level of CHO-H01, once a week for 4 weeks (Cycle 1-28-Day cycle).

From Cycle 2 onwards, on Day 1 of each subsequent 21-day cycle until disease progression (or a total of 6 cycles \[19 weeks\] of study).

CHO-H01+Lenalidomide

Expansion phase with lenalidomide combination.

Phase2a:

Single cohort at Recommended Phase 2 Dose (RP2D) of CHO-H01.

Group Type EXPERIMENTAL

CHO-H01 at RP2D

Intervention Type DRUG

Subjects will be administered intravenous (IV) infusion of RP2D level of CHO-H01, once a week for 4 weeks (Cycle 1-28-Day cycle).

From Cycle 2 onwards, on Day 1 of each subsequent 28-day cycle until disease progression (or a total of 6 cycles \[19 weeks\] of study).

Lenalidomide

Intervention Type DRUG

Subjects will receive oral lenalidomide 20 mg once daily from Day 1 to Day 21 per 28-day cycle.

Interventions

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CHO-H01

Phase 1:

Subjects will be administered intravenous (IV) infusion of assigned dose level of CHO-H01, once a week for 4 weeks (Cycle 1-28-Day cycle).

From Cycle 2 onwards, on Day 1 of each subsequent 21-day cycle until disease progression (or a total of 6 cycles \[19 weeks\] of study).

Intervention Type DRUG

CHO-H01 at RP2D

Subjects will be administered intravenous (IV) infusion of RP2D level of CHO-H01, once a week for 4 weeks (Cycle 1-28-Day cycle).

From Cycle 2 onwards, on Day 1 of each subsequent 28-day cycle until disease progression (or a total of 6 cycles \[19 weeks\] of study).

Intervention Type DRUG

Lenalidomide

Subjects will receive oral lenalidomide 20 mg once daily from Day 1 to Day 21 per 28-day cycle.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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:

1. Low grade lymphoma: follicular lymphoma (Grades 1-3a), marginal zone lymphoma, small lymphocytic lymphoma;
2. 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).

Exclusion Criteria

* Must not have a history of egg allergy or allergic reactions to any component of CHO-H01.
* Must not have any known or current illnesses (such as autoimmune disease, unless well controlled or resolved), infection, or other condition that could limit study compliance or interfere with assessments.
* Subjects who have received anti-programmed death-ligand 1 (PD-L1), programmed cell death 1 (PD-1), or cytotoxic T-lymphocyte associated protein 4 (CTLA-4) therapy.
* Subjects who have completed an autologous stem cell transplant within 100 days prior to CHO-H01 therapy or an allogeneic stem cell transplant.
* Subjects with known hepatitis B surface antigen (HBsAg) seropositive or known or suspected active hepatitis C infection with detectable viral load.
* Subjects with known human immunodeficiency virus (HIV) infection
* Subjects who have had radiation therapy, major surgical procedure or live vaccinations within 28 days prior to CHO-H01 administration.
* Subjects with a history of type I hypersensitivity or anaphylactic reactions to murine proteins or to previous infusions of CD20 monoclonal antibodies.
* Subjects who have received (or are receiving) systemic corticosteroids:

1. At a daily dose higher than 15 mg prednisone or equivalent within 14 days prior to the first administration of CHO-H01;
2. Topical, inhaled, nasal, and ophthalmic steroids are allowed.
* Inadequate bone marrow, hepatic or renal function.
* Subjects with a history of seizure disorder.
* Subjects who are pregnant or breast feeding.
* Subjects with any contraindications to lenalidomide (Only for phase IIa).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No