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Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma

Study Purpose

Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. Genetically engineered lymphocyte (CART) therapy has showed good safety and efficacy in treatment of lymphoma and acute lymphoblastic leukemia. Researchers want to see if this helps people with multiple myeloma.To test the safety and efficacy of giving targeting CD138 or B-cell maturation antigen or CD19 or more antigens T cells in treating patients with multiple myeloma that is refractory to further chemotherapy or relapsed(after stem cell transplantation or intensive chemotherapy).

Recruitment Criteria

Accepts Healthy Volunteers

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

 Yes
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.

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

Inclusion Criteria:

  • - CD138 or BCMA antigen positive multiple myeloma in patients with no available curative treatment options (such as autologous or allogeneic SCT).
  • - Relapsed and/or refractory multiple myeloma.
  • - Relapsed after prior autologous or allogenic SCT.
  • - Expected survival ≥ 3 months.
  • - Creatinine < 2.0 mg/dl.
  • - Blood coagulation function: PT and APTT < 2x normal.
  • - Arterial blood oxygen saturation > 92% - Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) < 3x normal.
  • - Karnofsky scores ≥ 60 and ECOG score ≤ 2.
  • - Adequate venous access for apheresis, and no other contraindications for leukapheresis.
  • - Patients should not take system chemotherapy in one month and immunotherapy in three months prior to CART cells infusion.
  • - Voluntary informed consent is given.

Exclusion Criteria:

  • - Pregnant or lactating women.
  • - Uncontrolled active infection.
  • - Active hepatitis B or hepatitis C infection.
  • - Concurrent use of systemic steroids.
Recent or current use of inhaled steroids is not exclusionary.
  • - Previously treatment with any gene therapy products.
  • - Any uncontrolled active medical disorder that would preclude participation as outlined.
  • - HIV infection.
  • - History of myocardial infarction and severe arrhythmia in half a year.
  • - Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
- Patients with fever of unknown origin (T > 38℃)

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.

 NCT03196414
Phase

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.

 Phase 1/Phase 2
Lead Sponsor

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

 The First Affiliated Hospital of Soochow University
Principal Investigator

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

 Fu cheng cheng, PhD
Principal Investigator Affiliation First Affiliated Hospital,Soochow University
Agency Class

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

 Other
Overall Status Recruiting
Countries China
Conditions

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

 Multiple Myeloma
Additional Details

Adults ages 18-75 with Relapsed and/or Chemotherapy Refractory Multiple Myelomas. Design: Participants may be screened with: Medical history Physical exam Blood and urine tests Heart tests Bone marrow sample Multiple scans and X-rays Lymphocytes are collected by apheresis from the enrolled patient or a healthy donor. Blood is removed through a needle in an arm. The rest of the blood is returned through a needle in the other arm. The cells will be changed in a laboratory. Participants will get 2 chemotherapy drugs over 5 days. Two days later, participants will get an intravenous (IV) catheter in an arm. They will get the split doses CART cells on day0, day1, day2 through the IV in 1 infusion. After this, participants will stay in the hospital for at least 9 days and stay nearby for 2 weeks. Then they will have blood tests and see a doctor. Participants will visit the clinic at 1, 2, 3, 6, 9 and 12 months after the infusion, then every 6 months until two years after infusion. A bone marrow sample will be taken at the 3-month visit.

Arms & Interventions

Arms

Experimental: CART-138/BCMA/19/more

Interventions

Biological: - CART-138/BCMA/19/more

Cyclophosphamide，Fludarabine，CART-138/BCMA /19/more cells Cyclophosphamide: 300 mg/m2 IV over 30 minutes on days -5 , -4,and -3; Fludarabine: 30 mg/m2 IV over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Biological: Anti-CD138/BCMA/CD19/more total CART cells 5x106- 100x106 CAR+ T cells per kg of recipient bodyweight

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

Suzhou, Jiangsu, China

Status

Recruiting

Address

First Affiliated Hospital, Soochow University

Suzhou, Jiangsu, 215000

Site Contact

Ling zhi Yan, Phd

yanlingzhi@suda.edu.cn

13584821140

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