RecruitingNot ApplicableNCT06279026

UTAA17 Injection in the Treatment of Relapsed/Refractory Multiple Myeloma

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

Sponsor

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Enrollment

15 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Relapsed/Refractory Multiple Myeloma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy called UTAA17 — a treatment that uses a patient's own genetically engineered immune cells to attack multiple myeloma cells — in patients whose cancer has come back or stopped responding to multiple prior treatments. **You may be eligible if...** - You are 18 years or older with confirmed relapsed or refractory multiple myeloma - Your cancer has failed or relapsed after at least 3 prior lines of therapy (including both a proteasome inhibitor and an immunomodulator) - Your cancer tests positive for a protein called BCMA - You have measurable disease based on blood, urine, or bone marrow tests - You are ineligible for or have relapsed after a stem cell transplant **You may NOT be eligible if...** - You have not had at least 3 prior treatment lines - Your myeloma does not express BCMA - Your disease is not measurable by standard criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALUTAA17 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.