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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03196414
• Other study ID #: myeloma-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 2016
• Est. completion date: December 2026

Study information

• Verified date: September 2016
• Source: The First Affiliated Hospital of Soochow University
• Contact: Ling zhi Yan, PhD
• Phone: 13584821140
• Email: yanlingzhi[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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?)

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
China	First Affiliated Hospital, Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Investigators try to test CART 138 cells copies in vivo.	CART Cell survival time by testing CART-138/BCMA cells copies in vivo through PCR Method.	2 years
Primary	Determine if there is grade 3 to 5 cytokine release syndrome	Number of Patients With Grade 3 Through Grade 5 Cytokine Release Syndrome(CRS) That Are Related to Study Intervening Measures, Graded According to NCI CTCAE Version 4.0	2 weeks-12 months after initial dose
Secondary	Investigators try to assess major reaction rate (MRR, PR+VGPR+CR) at the end of the research.	Number of Patients achieved major reaction rate (MRR;PR+VGPR+CR) According to IMWG response criteria at the end of the research.	up to 24 weeks