UTAA17 Injection in the Treatment of Relapsed/Refractory Multiple Myeloma

February 23, 2024 updated by: PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Single-arm, Open-label, Early-stage Clinical Study of UTAA17 Injection in the Treatment of Relapsed/Refractory Multiple Myeloma

The clinical trial was designed as a single-arm, open-label clinical study, with the main purpose of exploring the safety, pharmacokinetics, and best recommended dose (RP2D) of the UTAA17 injection in the treatment of relapsed or refractory multiple myeloma (r/r MM) subjects, and also the efficacy will be observed. Eligible subjects will accept the infusion of UTAA17 injection after pretreatment, and their blood will be collected before and after infusion for evaluation of pharmacokinetics, immunogenicity and safety. This study plans to evaluate efficacy using the revised Evaluation of Efficacy in multiple myeloma -IMWG criteria (2016), which will be evaluated at 4w, 2m, 3m, 6m, and 6 to 24m (at a frequency of Q3m) after cell reinfusion, in addition to the baseline period. Efficacy evaluation continues until one of the following occurs: subject disease progression (PD), acceptance of a new antitumor therapy, death, occurrence of intolerable toxicity, investigator decision, or patient decision to withdraw.

Study Overview

Status

Status

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

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.

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 (Estimated)

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.
15

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.
  • Not Applicable

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.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Recruiting
        • The Second Affiliated Hospital of Soochow University
        • 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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All subjects or legal representatives must sign an informed consent form approved by the Ethics Committee in person before commencing any screening process.
  • ≥18 years old, regardless of gender, diagnosed with relapsed or refractory multiple myeloma according to the Efficacy Evaluation Criteria for multiple myeloma (IMWG), where relapsed or refractory is defined as: Multiple myeloma that has failed or relapsed after at least 3 lines of therapy (including proteasome inhibitor and immunomodulator-based chemotherapy regimen) in which induction chemotherapy, stem cell transplantation, and maintenance therapy given consecutively are considered a treatment regimen if no disease progression occurs during treatment.

  • The presence of measurable lesions at the time of screening will be determined according to any of the following criteria:

    1. Monoclonal plasma cells in bone marrow ≥ 10%.
    2. Serum monoclonal protein (M-protein) level ≥10 g/L.
    3. Urinary M protein level ≥200 mg/24 hours.
    4. Light chain multiple myeloma with no measurable lesions in serum or urine: serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin κb /γ free light chain ratio.
    5. There are extramedullary lesions.
  • BCMA expression on the cell membrane is positive by flow cytometry and/or immunohistochemistry.
  • Patients were unable to undergo autologous hematopoietic stem cell transplantation or relapsed after autologous hematopoietic stem cell transplantation and were determined by the investigators to require treatment.
  • Patients who have previously received CAR T cell therapy should not be included until at least 3 months after the last CAR T cell infusion and no previously used CAR T cells are detectable in peripheral blood or bone marrow.
  • The ECOG score is 0 or 1.
  • Expected survival ≥12 weeks.

  • Subjects must have appropriate organ function and meet all of the following laboratory test results prior to enrollment

    1. Blood routine: Absolute neutrophil count (ANC) >0.75×10^9 /L; Absolute lymphocyte count (ALC) ≥0.3×10^9 /L; Platelet ≥50×10^9 /L; Hemoglobin >60 g/L
    2. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × upper limit of normal (ULN); Serum total bilirubin ≤1.5×ULN, except patients with Gilbert syndrome (patients with Gilbert syndrome ≤3.0 times the upper limit of normal and direct bilirubin ≤1.5 times the upper limit of normal can be included)
    3. Renal function: serum creatinine ≤2.5×ULN
    4. Coagulation function: fibrinogen ≥ 1.0g /L; Activated partial thromboplastin time, activated partial thromboplastin time ≤1.5×ULN, and prothrombin time (PT) ≤1.5×ULN
    5. Must have a minimum level of lung reserve, blood oxygen saturation > 92%
  • Hemodynamically stable and left ventricular ejection fraction (LVEF) ≥ 50% as determined by echocardiography.

Exclusion Criteria:

  • Patients who were determined by the investigators to require long-term immunosuppressant use during screening.
  • Cerebrovascular accident or convulsive attack occurred within 6 months before signing the informed consent.
  • Other malignancies other than MM, except carcinoma in situ.
  • Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA test positive; EBV virus DNA and herpes virus DNA positive test; Syphilis test positive.
  • Serious heart disease: including, but not limited to, unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmia.
  • Unstable systemic disease, as determined by the investigator: including, but not limited to, severe liver, kidney, or metabolic disease requiring medical treatment.
  • There are chronic progressive neurological disorders.
  • Patients who have not yet recovered from the acute toxic effects of prior treatment.
  • Presence of active or uncontrolled infections that require systemic treatment (except for mild genitourinary and upper respiratory tract infections).
  • Female subjects who are capable of becoming pregnant and plan to become pregnant within 2 years after cell transfusion; Or a male subject whose partner plans to become pregnant within 2 years of cell transfusion.
  • The researchers assessed that there were other conditions that were not suitable for inclusion.

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: UTAA17 Injection
After signing informed consent, subjects will be screened according to inclusion/exclusion criteria. Successful subjects will receive 3E8 CAR+γδT, 5E8 CAR+γδT, 1E9 CAR+γδT, 5E9 CAR+γδT, 1E10 CAR+γδT cell transfusions in sequence, and each subject will receive only one dose.
Biological: UTAA17 Injection
After signing informed consent, subjects will be screened according to inclusion/exclusion criteria. Successful subjects will receive 3E8 CAR+γδT, 5E8 CAR+γδT, 1E9 CAR+γδT, 5E9 CAR+γδT, 1E10 CAR+γδT cell transfusions in sequence, and each subject will receive only one dose.
Other Names:
  • Chimeric antigen receptor modified T cell injections targeting BCMA

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
DLT
Time Frame: About 28 days
Dose limiting toxicity
About 28 days
RP2D
Time Frame: About 1 years
Best recommended dose
About 1 years

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.
PersonGen BioTherapeutics (Suzhou) Co., Ltd.

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.
Second Affiliated Hospital of Soochow University

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 (Estimated)

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.
April 1, 2024

Primary Completion (Estimated)

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.
April 1, 2027

Study Completion (Estimated)

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.
July 1, 2027

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).
January 26, 2024

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.
February 23, 2024

First Posted (Estimated)

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.
February 26, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
February 26, 2024

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.
February 23, 2024

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.
January 1, 2024

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.
  • PG-006-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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