NCT06279026

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Relapsed/Refractory Multiple Myeloma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-01
• Primary completion: 2027-04-01
• Completion: 2027-07-01
• First posted: 2024-02-26
• Last updated: 2024-02-26

Locations

1 site across 1 country: China