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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
EVIVE Biotechnology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University Cancer Hospital & Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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