Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma (A-319)

August 13, 2019 updated by: EVIVE Biotechnology

A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma

Title: A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Protocol Number: SP071744 Study Stage: Phase I Study Number: 1 site Subject Number: up to 54 patients with Relapsed or Refractory B-cell Lymphoma

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 1

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

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

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-75 years, all genders
  • Patients with definite B-cell Lymphoma, includes FL, MZL, MCL, DLBCL.
  • Patients With Relapsed or Refractory B-cell Lymphoma
  • ECOG ≤ 2
  • Lesions are measurable in 21 days before treatment
  • Normal bone marrow function
  • Normal liver, kidney, lung and heart function
  • the Subjects can sign the ICF and obey the protocol, elsewise, his/her guardian should sign
  • Life expectancy is at least 3 months

Exclusion Criteria:• Past or present CNS disease

  • Associated with lymphoma by the infiltrates of CNS
  • A history of autoimmune disease with CNS involvement or autoimmune disease
  • Previous history of autoimmune disease or other malignancy
  • A history of deep venous thrombosis or pulmonary embolism
  • Auto-HSCT was performed within 12 weeks prior to initiation of treatment
  • Previous organ transplantation or allogeneic hematopoietic stem cell transplantation
  • The Investigator determined that the patients were associated with a disease, medical condition, or social factor that might affect study results or compliance
  • Immunosuppressant are being used
  • Radiotherapy was given within 6 weeks prior to A-319 treatment
  • Chemotherapy, immunotherapy and targeted therapy were received within 4 weeks before A-319 treatment
  • Previous CAR-T cell therapy
  • Received anti-lymphoma drugs in the first 4 weeks of A-319 treatment
  • There was no recovery of toxic effects (CTCAE> grade 1 adverse events) at the last treatment, except hair loss
  • Those who underwent major surgery 28 days before enrollment (excluding lymph node biopsy);Or plan to operate during the study period
  • Those who had received active/attenuated live vaccine within 28 days prior to screening
  • For pregnant (positive pregnancy test) and lactating women, those of childbearing age who signed the informed consent form and did not agree to use contraception for at least 3 months after the end of the study;Within 7 days prior to the first day of treatment, women of childbearing age require a positive serum pregnancy test (HCG)
  • Male patients who signed informed consent forms and did not agree to use contraception for at least 3 months at the end of the study (except surgical sterilization)
  • Known allergy to immunoglobulin or research drugs and their excipients
  • Patients considered unfit to participate in the study

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single arm
A-319 dosage: 0.05, 0.15, 0.03, 0.06, 0.12, 0.18, 0.24 μg/kg
Biological: Recombinant Anti-CD19m-CD3 Antibody Injection
Intravenous Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the Incidence and Characteristics of SAE of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
Incidence and Characteristics of SAE
At the end of Cycle 1 (each cycle is 28 days)
Evaluate the MTD and DLT of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
dose limited toxicity(DLT), maximum tolerance dose(MTD)
At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the PK(Cmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Time Frame: At the end of Cycle3 (each cycle is 28 days)
Peak Plasma Concentration(Cmax)
At the end of Cycle3 (each cycle is 28 days)
Evaluate the PK(AUC) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Time Frame: At the end of Cycle3 (each cycle is 28 days)
Area under the plasma concentration versus time curve(AUC)
At the end of Cycle3 (each cycle is 28 days)
Evaluate the PK(Tmax) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Time Frame: At the end of Cycle3 (each cycle is 28 days)
time to peak (Tmax)
At the end of Cycle3 (each cycle is 28 days)
Evaluate the PK(T1/2) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Time Frame: At the end of Cycle3 (each cycle is 28 days)
half-life time(T1/2)
At the end of Cycle3 (each cycle is 28 days)
Evaluate the PK(CL) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Time Frame: At the end of Cycle3 (each cycle is 28 days)
clearance(CL)
At the end of Cycle3 (each cycle is 28 days)
Evaluate the PK(Vz) of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Time Frame: At the end of Cycle3 (each cycle is 28 days)
volume of distribution(Vz)
At the end of Cycle3 (each cycle is 28 days)
Evaluate the PD of A-319 Treat on Relapsed or Refractory B-cell Lymphoma
Time Frame: At the end of Cycle3 (each cycle is 28 days)
B-cell level
At the end of Cycle3 (each cycle is 28 days)

Collaborators and Investigators

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

Sponsor

EVIVE Biotechnology

Collaborators

Peking University Cancer Hospital & Institute

Investigators

  • Principal Investigator: Song Yuqin, Doctor, Peking University Cancer Hospital & Institute

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)

September 15, 2019

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

January 27, 2022

Study Registration Dates

First Submitted

July 8, 2019

First Submitted That Met QC Criteria

August 13, 2019

First Posted (Actual)

August 14, 2019

Study Record Updates

Last Update Posted (Actual)

August 14, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP071744

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all IPD

IPD Sharing Time Frame

After 20January2022(estimated), for 1years(estimated).

IPD Sharing Access Criteria

All.

IPD Sharing Supporting Information Type

  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

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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