A Study of MIL62 Combined With Orelabrutinib for the Treatment of R/R CD20+B Cell Lymphoma

NCT04304040 | Active Not Recruiting Phase 1

• 1 other identifier: MIL62-CT03
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 10

Brief Summary

Dose escalation and expansion phase I/IIa clinical study of recombinant humanized type II CD20 monoclonal antibody MIL62 injection combined with a novel selective Bruton Tyrosine Kinase(BTK) inhibitor Orelabrutinib in the treatment of recurrent/refractory CD20+B cell lymphoma

Conditions

B-cell Lymphoma Recurrent; B-cell Lymphoma Refractory

Keywords

CD20+

Outcome Measures

Primary Outcomes (4)

• Dose limiting toxicity (DLT)(Dose escalation phase)

  Safety observation indicator

  At the end of Cycle 1 (each cycle is 28 days)

• Maximum tolerated dose (MTD) (Dose escalation phase)

  Safety observation indicator

  At the end of Cycle 1 (each cycle is 28 days)

• Recommended dose for phase 2 trials of two-drug combinations (RP2D) (Dose escalation phase)

  Safety observation indicator

  At the end of Cycle 1 (each cycle is 28 days)

• objective remission rate(ORR) (Dose expansion phase)

  Efficacy observation indicator

  At the end of Cycle 30 (each cycle is 28 days)

Secondary Outcomes (10)

• objective remission rate(ORR)

  At the end of Cycle 30 (each cycle is 28 days)

• Area under the plasma concentration vs time curve(AUC)

  At the end of Cycle 6 (each cycle is 28 days)

• Apparent half-life for designated elimination phases (t½)

  At the end of Cycle 6 (each cycle is 28 days)

• The peak plasma concentration (Cmax)

  At the end of Cycle 6 (each cycle is 28 days)

• Duration of remission(DOR)

  3 years after first treatment

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: Orelabrutinib; Drug: Recombinant humanized monoclonal antibody MIL62 injection

Interventions

Orelabrutinib DRUG

BTK inhibitor Orelabrutinib low dose or high dose; Part A:28days/cycle, Cycle1:35days; Part B:21 days/cycle, Cycle1:28days.

Single Arm

Recombinant humanized monoclonal antibody MIL62 injection DRUG

Recombinant humanized monoclonal antibody MIL62 injection, 800mg or1000mg each time, Part A:28days/cycle, Cycle1:35days; Part B:21 days/cycle, Cycle1:28days.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years, gender not limited
• Dose escalation phase: Histologically confirmed CD20 positive B-cell non-Hodgkin's lymphoma; Expansion stage: R/R NHL Or histologically diagnosed CD20 positive chronic lymphocytic leukemia/small lymphocytic lymphoma;
• Dose escalation phase ：Patients who have received at least one treatment regimen Expansion stage：Patients who have received at least one to four treatment regimens with at least one regimen containing rituximab;
• Eastern cancer collaboration group(ECOG) physical status score: 0-2
• Laboratory tests performed within 7 days prior to the first acceptance of the study drug met the protocol criteria.
• Expected survival ≥6 months
• Sign a written informed consent.

You may not qualify if:

• Expansion stage: DLBCL transformed from follicular lymphoma, DLBCL with follicular lymphoma, and lymphomas with primary or central nervous system involvement.
• Received any of the anti-tumor treatments(note in the protocol) before the first study drug.
• Previous use of any anticancer vaccine.
• Patients who had received hematopoietic stem cell transplantation within 3 months before the first administration
• Patients scheduled for major surgery within 28 days prior to initial administration or during the expected study period.
• Patients who Is participating in other clinical trials or first administration less than 28 days after the end of the previous clinical trial.
• Receiving prednisone treatment or other corticosteroid treatment with the same dose as prednisone ;Patients who require warfarin or an equivalent vitamin K antagonist;
• During the study period, drugs with moderate or severe inhibition or strong induction of cytochrome CYP3A4 were taken together;
• Subject has a history of any of the diseases note in the protocol;
• Patients with infections;
• Impact testing scheme compliance or other serious results explain the poor control of the merger of the disease(note in the protocol);
• Toxicity of any previous anticancer treatment has not recovered to ≤1, except for hair loss;
• A history of severe allergic reactions to humanized monoclonal antibodies or known allergies to any component of Orelabrutinib or MIL62;
• Inability to swallow research drugs, or the presence of conditions that significantly affect gastrointestinal function;
• Hepatitis b surface antigen (HBsAg) and/or hepatitis b core antibody (HBcAb) are positive ; Hepatitis c virus (HCV) antibody positive and HCV RNA positive patients; Human immunodeficiency virus (HIV) serum response was positive;

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (10)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 100000, China

Location

Beijing Hospital

Beijing, Beijing Municipality, 100000, China

Location

Beijing Shijitan hospital, capital medical university

Beijing, Beijing Municipality, 100000, China

Location

Cancer hospital, Chinese academy of medical sciences

Beijing, Beijing Municipality, 100000, China

Location

Affiliated Hospital of Hebei University

Baoding, Hebei, 100000, China

Location

Henan Tumor Hospital

Zhengzhou, Henan, 100000, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 100000, China

Location

First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 100000, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 100000, China

Location

Tianjin People's Hospital

Tianjin, Tianjin Municipality, 100000, China

Location

MeSH Terms

Interventions

orelabrutinib

Study Officials

• Yuankai Shi, PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 11, 2020
• Study Start: July 28, 2020
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)