Actively Recruiting
APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma
Led by Zhejiang University · Updated on 2022-05-09
36
Participants Needed
1
Research Sites
276 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
A study of APRIL CAR-T cells therapy for patients with BCMA/TACI positive relapsed and/or refractory multiple myeloma
CONDITIONS
Official 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
- Patients with relapsed multiple myeloma after BCMA CAR-T therapy or hematopoietic stem cell transplantation
- Cases with recurrent positive minimal residual disease
- Presence of extramedullary lesion difficult to treat with chemotherapy or radiotherapy
- Male or female aged 18 to 75 years
- Total bilirubin 64 51 umol/L, ALT and AST 64 3 times upper limit of normal, creatinine 64 176.8 umol/L
- Left ventricular ejection fraction (LVEF) 64 50% on echocardiogram
- No active lung infection, blood oxygen saturation 64 92% in indoor air
- Estimated survival time of at least 3 months
- ECOG performance status between 0 and 2
- Voluntary participation with signed informed consent
You will not qualify if you...
- History of craniocerebral trauma, consciousness disturbance, epilepsy, cerebrovascular ischemia, or hemorrhagic diseases
- Electrocardiogram showing prolonged QT interval or severe heart disease such as severe arrhythmia
- Pregnant or lactating women
- Severe active infections (excluding simple urinary tract infection and bacterial pharyngitis)
- Active hepatitis B or C virus infection
- Systemic steroid therapy within 2 weeks prior to screening (except inhaled steroids)
- Previous treatment with any CAR-T cell or other genetically modified T cell therapies
- Creatinine level > 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 the investigator believes increases patient risk or interferes with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
Y
Yongxian Hu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here