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APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma

RecruitingEARLY Phase 1Ages 18 Years - 75 YearsAllZhejiang University
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In plain words

What the trial is, and whether it could suit you

A study of APRIL CAR-T cells therapy for patients with BCMA/TACI positive relapsed and/or refractory multiple myeloma

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Histologically confirmed diagnosis of BCMA/TACI+ multiple myeloma (MM): 1. Patients with MM relapsed after BCMA CAR-T therapy; Or MM with positive BCMA/TACI expression; 2. Relapsed after hematopoietic stem cell transplantation; 3. Cases with recurrent positive minimal residual disease; 4. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy. 2. Male or female aged 18-75 years; 3. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L; 4. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%; 5. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%; 6. Estimated survival time ≥ 3 months; 7. ECOG performance status 0 to 2; 8. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent. Exclusion Criteria: Subjects with any of the following exclusion criteria were not eligible for this trial: 1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases; 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; 3. Pregnant (or lactating) women; 4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); 5. Active infection of hepatitis B virus or hepatitis C virus; 6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids; 7. Previously treated with any CAR-T cell product or other genetically modified T cell therapies; 8. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl; 9. Other uncontrolled diseases that were not suitable for this trial; 10. Patients with HIV infection; 11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study
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What it tests

  • APRIL CAR-T cells
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Where

1 site
The First Affiliated Hospital,College of Medicine, Zhejiang University
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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