Actively Recruiting
Clinical Trial for Safety and Efficacy of APRIL CAR-T Cells Therapy in BCMA/TACI Positive Relapsed or Refractory Multiple Myeloma
Led by Zhejiang University · Updated on 2022-05-09
36
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
Y
Yake Biotechnology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating APRIL CAR-T cell therapy for patients with BCMA/TACI positive relapsed or refractory multiple myeloma. This is an early phase 1, single-arm, open-label study designed to explore the safety and dose-related safety of this treatment. The study is conducted at a single center and plans to enroll 36 patients who have relapsed or refractory multiple myeloma expressing BCMA or TACI markers. Each participant receives APRIL CAR-T cells through a single intravenous infusion. The study focuses mainly on monitoring dose-limiting toxicities within 28 days after infusion. The trial continues for up to two years to observe any treatment-emergent adverse events and evaluate the therapy's impact on overall response, survival, and quality of life. No placebo or comparison group is involved, and the dose levels are selected based on similar clinical trials. Participants are closely monitored with regular assessments including overall response rate at various months up to two years, overall and event-free survival, and quality of life measures such as physical activity and daily living scores. Anxiety and depression levels are also evaluated periodically. Safety is followed up for up to two years post-infusion, with detailed evaluations of liver function, heart function, infection status, and general health throughout the study period.
CONDITIONS
Brief Title
APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of BCMA/TACI positive multiple myeloma
- Relapsed after BCMA CAR-T therapy or hematopoietic stem cell transplantation, or with recurrent positive minimal residual disease, or with extramedullary lesion hard to eradicate by chemotherapy or radiotherapy
- Male or female aged 18 to 75 years
- Total bilirubin ≤ 51 umol/L; ALT and AST ≤ 3 times upper limit of normal; creatinine ≤ 176.8 umol/L
- Left ventricular ejection fraction ≥ 50% by echocardiogram
- No active lung infection and blood oxygen saturation ≥ 92% in indoor air
- Estimated survival time of at least 3 months
- ECOG performance status 0 to 2
- Voluntary participation with signed informed consent
You will not qualify if you...
- History of brain trauma, unconsciousness, epilepsy, cerebrovascular ischemia or hemorrhagic diseases
- Prolonged QT interval or severe heart diseases such as severe arrhythmia
- Pregnant or breastfeeding women
- Severe active infections excluding simple urinary tract infection or bacterial pharyngitis
- Active hepatitis B or C infection
- Systemic steroid therapy within 2 weeks prior to screening except inhaled steroids
- Previous treatment with any CAR-T or genetically modified T cell therapies
- Creatinine > 2.5 mg/dl, ALT or AST > 3 times normal, or bilirubin > 2.0 mg/dl
- Other uncontrolled diseases unsuitable for the trial
- HIV infection
- Any condition that may increase risk or interfere with study results as judged by investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days after infusion
Participants receive APRIL CAR-T cells by intravenous infusion as a treatment for BCMA/TACI positive relapsed and/or refractory multiple myeloma.
1 infusion visit and multiple follow-up visits for safety monitoring up to 28 days
Duration - Up to 2 years after infusion
Participants are monitored for treatment-emergent adverse events, overall response, and quality of life for up to 2 years after the infusion.
Visits at Month 1, 3, 6, 9, 12, 18, and 24 for assessments
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital，College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
H
He Huang, PhD
Y
Yongxian Hu, PhD
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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