Efficacy and Safety Evaluation of PD1-BCMA-CART

Study Purpose

This trial aims to evaluate the safety and efficacy of PD1-BCMA-CART in treating patients with relapsed 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 - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Have the capacity to give informed consent; - Confirmed diagnosis of active MM as defined by NCCN and IMWG criteria; - Have a diagnosis of BCMA+ multiple myeloma (MM), (≥ 5% BCMA+ in CD138+ plasma cells by flow cytometry obtained within 45 days of study enrollment); - Refractory and relapsed MM patients after > 2 cycles of induction therapy,or,have relapsed or treatment refractory disease following autologous stem cell transplant (ASCT); - ECOG score=0-2.
  • - Subjects according with any of the following options: - Age≥50; - Failure with separation of T cells during autologous CART processing; or, - Failure with expansion of autologous CART; or, - The proportion of T cells in PBMC <10%; or, - Won't benefit from autologous CART therapy because of disease progress.

Exclusion Criteria:

  • - Pregnant or nursing women; Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours of starting conditioning chemotherapy.
  • - Active infection, HIV infection, syphilis serology reaction positive; - Active hepatitis B, hepatitis C at the time of screening.
  • - Significant hepatic dysfunction as following, SGOT(serum glutamic-oxaloacetic transaminase)> 5 x upper limit of normal; bilirubin > 3.0 mg/dL; - Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis.
  • - serious mental disorder; - With severe cardiac, liver, renal insufficiency, diabetes and other diseases; - Participate in other clinical research in the past three months; previously treatment with any gene therapy products.
- Contraindication to cyclophosphamide or fludarabine chemotherapy

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.

Lead Sponsor

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

Bioray Laboratories
Principal Investigator

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

Yi Zhang, Professor
Principal Investigator Affiliation First Affliated Hospital of Zhengzhou University
Agency Class

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

Industry, Other
Overall Status Not yet recruiting
Countries China

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

Multiple Myeloma
Additional Details

Using gene editing, chimeric antigen receptors recognizing BCMA were integrated into subject self-derived T cells to obtain a large number of BCMA-CART by in vitro amplification, and BCMA-CART back into the subjects could identify and kill myeloma cells in the subjects.This open-label, dose-escalation study was designed to evaluate the safety and antitumor efficacy of PD1-BCMA-CART in the treatment of relapsed or refractory multiple myeloma.

Arms & Interventions


Experimental: PD1-BCMA-CART

Each subject will accept one of the following dosages of PD1-BCMA-CART cells intravenously (IV) on day 0: 0.5-2*10^6/KgBW.


Biological: - PD1-BCMA-CART

Single infusion of PD1-BCMA-CART administered intravenously (i.v.)

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

Zhengzhou, Henan, China



First Affliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052