Tests APRIL CAR-T cell therapy in adults with relapsed multiple myeloma
Tests APRIL CAR-T cells in adults with relapsed or refractory multiple myeloma.
Plain-language title generated from the registry record
Registry title: APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT04657861, who can take part
Where in China
- The First Affiliated Hospital, College of Medicine, Zhejiang UniversityHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zhejiang University
- Trial code
- NCT04657861
- Record updated
- 9 May 2022
- Original description
A study of APRIL CAR-T cells therapy for patients with BCMA/TACI positive relapsed and/or refractory multiple myelomaRead full original descriptionShow less
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
A study of APRIL CAR-T cells therapy for patients with BCMA/TACI positive relapsed and/or refractory multiple myeloma
Inclusion: 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: 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; History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases; Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); Active infection of hepatitis B virus or hepatitis C virus; Other uncontrolled diseases that were not suitable for this trial; Patients with HIV infection; Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl; Subjects with any of the following exclusion criteria were not eligible for this trial:; Pregnant (or lactating) women; Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.