IBI376 in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma

A Phase 2, Multicenter, Open-Label Study of IBI376, a PI3Kδ Inhibitor, in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma

A Phase 2, Multicenter, Open-Label Study of IBI376, a PI3Kδ Inhibitor, in Patients with Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma

Study Overview

• Status: Active, not recruiting
• Conditions: Indolent Non-hodgkin Lymphoma
• Intervention / Treatment: Drug: IBI376

Detailed Description

Patients will be recruited for 2 cohorts. Cohort A will recruit 58 RRFL subjects, and Cohort B will recruit 62 RRMZL subjects.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Ruijin hospital, school of medicine, Shanghai jiao tong university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged 18 years or older.
2. Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (FL) Grade 1, 2, and 3a or MZL.
3. Ineligible for hematopoietic stem cell transplant.
4. Definition of RRFL or RRMZL: Subjects should have received 2 or more prior therapies for FL/MZL included at least one regimen containing Rituximab. Subjects should be refractory to Rituximab or experienced disease progression after achieved remission or disease progression within 6 months since last therapy.
5. Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography (CT) or magnetic resonance imaging (MRI).
6. Subjects must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
7. ECOG performance status 0 to 2.
8. Life expectancy ≥ 12 weeks.
9. Adequate hematologic, hepatic, and renal function.
10. Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

1 . Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.

2. History of central nervous system lymphoma (either primary or metastatic).

3. Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan-PI3K inhibitor.

4. Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).

5. Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration.

6. Active graft-versus-host disease. 7. Subjects positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for HBV-DNA. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI376; IBI376 will be administered orally at a dose of 20 mg once daily for 8 weeks followed by 2.5 mg once daily.	Drug: IBI376; IBI376 20 mg po. once daily for 8 weeks ，followed by 2.5mg once daily; Other Names: Parsaclisib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	To assess the efficacy of IBI376 in terms of objective response rate (ORR) in subjects with relapsed or refractory follicular lymphoma (FL)/Marginal lymphoma(MZL). Subjects will be evaluated for ORR by an IRC (Lugano criteria)	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response Rate (CRR)	To assess complete response rate (CRR)	2 years
Duration of Response (DOR)	To assess the duration of response (DOR)	2 years
Progression-free Survival (PFS)	To assess progression-free survival (PFS)	2 years
Overall Survival (OS)	To assess overall survival (OS)	2 years
Best percentage change in target lesion size	To assess best percentage change in target lesion size	2 years
Safety and tolerability of IBI376 measured by adverse events (AEs)	Defined as any AE either reported for the first time or worsening of a pre-existing event after first dose of study treatment.	Baseline through 30-35 days after end of treatment, up to approximately 12 months per subject

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2020
• Primary Completion (Actual): July 27, 2021
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Follicular Lymphoma; Marginal Zone Lymphoma; Parsaclisib
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone
• Other Study ID Numbers: CIBI376A201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No