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UTAA17 Injection in the Treatment of Relapsed/Refractory Multiple Myeloma

NCT06279026 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-02-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Second Affiliated Hospital of Soochow University

    collaborator OTHER

  • PersonGen BioTherapeutics (Suzhou) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2027-04-01
Completion
2027-07-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06279026 on ClinicalTrials.gov