SHR1459 in Combination With YY-20394 in Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma

September 22, 2021 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Phase I/ II Study of SHR1459 in Combination With YY-20394 in Recurrent and Refractory B-cell Non-Hodgkin's Lymphoma in Adults

The study is evaluating the efficacy, and safety of SHR1459 combined with YY-20394 for Recurrent and refractory B-cell non-Hodgkin's lymphoma in adults.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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. Histologically confirmed diagnosis of B-cell NHL such as DLBCL, FL and MCL
  2. Patients received at least 2 lines of systemic therapy
  3. Previously received anti- CD20 treatment
  4. Patients in stage II should also be unsuitable or unwilling to receive allogeneic hematopoietic stem cell transplantation
  5. Patients must have an acceptable organ function

Exclusion Criteria:

  1. Previously treated with PI3K inhibitors or BTK inhibitors
  2. Unresolved toxicity of CTCAE grade > 1 from prior anti-lymphoma therapy
  3. Chemotherapy or other investigational therapy within 28 days (or 5 times the half-life time, whichever is shorter) before starting cycle 1
  4. Significant concurrent medical disease or condition which according to the investigators' judgement
  5. Active hepatitis B, C or HIV infection
  6. Infection requiring treatment 2 weeks prior to the first dosing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SHR1459 + YY-20394 (Stage 1)
Drug: SHR1459 ；YY-20394
SHR1459 plus YY-20394
EXPERIMENTAL: SHR1459 + YY-20394 (Stage 2)
Drug: SHR1459 ；YY-20394
SHR1459 plus YY-20394
EXPERIMENTAL: GemOx (Stage 2)
Drug: Gemcitabine-Oxaliplatin
Gemcitabine-Oxaliplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stage 1: MTD （Maximum tolerated dose）or RP2D（Recommended Phase II Dose) of SHR1459 and YY-20394;
Time Frame: Minimum observation period is 28 days for the maximum dose cohort
Minimum observation period is 28 days for the maximum dose cohort
Stage 2: Overall response rate (ORR)
Time Frame: 8 weeks after last patient first visit (LPFV)
8 weeks after last patient first visit (LPFV)

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of Adverse Events
Time Frame: At every treatment and follow up visit until disease progression. Expected to be for up to 6 months
At every treatment and follow up visit until disease progression. Expected to be for up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

October 1, 2021

Primary Completion (ANTICIPATED)

April 1, 2023

Study Completion (ANTICIPATED)

October 1, 2023

Study Registration Dates

First Submitted

June 28, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (ACTUAL)

July 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 22, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR1459-II-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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