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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Zhejiang University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries China

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma in Relapse, Multiple Myeloma, Refractory
Additional Details

This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory BCMA/TACI positive relapsed and/or refractory multiple myeloma. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 36 patients will be enrolled. Primary objective is to explore the safety, main consideration is dose-related safety.

Arms & Interventions


Experimental: Administration of APRIL CAR T-cells

Each subject receive APRIL CAR T-cells by intravenous infusion


Drug: - APRIL CAR-T cells

Each subject receive APRIL CAR T-cells by intravenous infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hangzhou, Zhejiang, China




The First Affiliated Hospital,College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003

Site Contact

He Huang, PhD