RecruitingEarly Phase 1NCT04657861
APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma
Clinical Trial for the Safety and Efficacy of APRIL CAR-T Cells Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma
Sponsor
Zhejiang University
Enrollment
36 participants
Start Date
May 3, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
A study of APRIL CAR-T cells therapy for patients with BCMA/TACI positive relapsed and/or refractory multiple myeloma
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria12
- Histologically confirmed diagnosis of BCMA/TACI+ multiple myeloma (MM)：
- Patients with MM relapsed after BCMA CAR-T therapy; Or MM with positive BCMA/TACI expression;
- Relapsed after hematopoietic stem cell transplantation;
- Cases with recurrent positive minimal residual disease;
- Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
- Male or female aged 18-75 years;
- Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
- Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
- No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
- Estimated survival time ≥ 3 months;
- ECOG performance status 0 to 2;
- Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.
Exclusion Criteria11
- History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
- Active infection of hepatitis B virus or hepatitis C virus;
- Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
- Previously treated with any CAR-T cell product or other genetically modified T cell therapies;
- Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
- Other uncontrolled diseases that were not suitable for this trial;
- Patients with HIV infection;
- Any situations that the investigator believes may increase the risk of patients or interfere with the results of study
Interventions
DRUGAPRIL CAR-T cells
Each subject receive APRIL CAR T-cells by intravenous infusion
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04657861
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