Actively Recruiting
UTAA17 Injection in the Treatment of Relapsed/Refractory Multiple Myeloma
Led by PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Updated on 2024-02-26
15
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
Sponsors
P
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Lead Sponsor
S
Second Affiliated Hospital of Soochow University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
UTAA17 Injection in the Treatment of Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form approved by Ethics Committee
- 18 years or older with relapsed or refractory multiple myeloma after at least 3 lines of therapy
- Measurable disease by defined criteria including bone marrow plasma cells ≥10%, serum M-protein ≥10 g/L, urinary M protein ≥200 mg/24 hours, or abnormal free light chain levels
- Positive BCMA expression on cancer cell membrane confirmed by flow cytometry or immunohistochemistry
- Unable to undergo or relapsed after autologous hematopoietic stem cell transplantation and requires treatment
- At least 3 months since last CAR T cell therapy and no detectable CAR T cells in blood or marrow
- ECOG score of 0 or 1
- Expected survival of at least 12 weeks
- Adequate organ function including specific blood counts, liver, kidney, coagulation, lung reserve, and heart function with LVEF ≥50%
You will not qualify if you...
- Requirement for long-term immunosuppressant use during screening
- Cerebrovascular accident or seizures within 6 months prior to consent
- Other cancers besides multiple myeloma except carcinoma in situ
- Positive tests for active infections including hepatitis B, hepatitis C, HIV, CMV, EBV, herpes viruses, or syphilis
- Serious heart disease such as recent heart attack, unstable angina, severe heart failure, or arrhythmia
- Unstable systemic diseases needing medical treatment
- Chronic progressive neurological disorders
- Not recovered from acute toxic effects of prior treatments
- Active or uncontrolled infections requiring systemic treatment
- Women planning pregnancy within 2 years post-treatment or men with partners planning pregnancy within 2 years
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
Research Team
B
Bingzong Li, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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