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

NCT03196414 | Recruiting Phase 1

• 1 other identifier: myeloma-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Investigators try to assess major reaction rate (MRR, PR+VGPR+CR) at the end of the research.

  up to 24 weeks

Other Outcomes (1)

• Investigators try to test CART 138 cells copies in vivo.

  2 years

Study Arms (1)

CART-138/BCMA/19/more

EXPERIMENTAL

Biological: CART-138/BCMA/19/more

Interventions

CART-138/BCMA/19/more BIOLOGICAL

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

CART-138/BCMA/19/more

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or lactating women
• Uncontrolled active infection.
• Active hepatitis B or hepatitis C infection.
• 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℃)

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

First Affiliated Hospital, Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

Related Publications (1)

• Zhang Y, Zhang C, Zhou J, Zhang J, Chen X, Chen J, Wang P, Sun X, Lou X, Qi W, Kang L, Yu L, Wu D, Li C. Case Report: Reversible Neurotoxicity and a Clinical Response Induced by BCMA-Directed Chimeric Antigen Receptor T Cells Against Multiple Myeloma With Central Nervous System Involvement. Front Immunol. 2021 Feb 25;12:552429. doi: 10.3389/fimmu.2021.552429. eCollection 2021.

  PMID: 33717057 DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Fu cheng cheng, PhD

  First Affiliated Hospital,Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ling zhi Yan, PhD

CONTACT

13584821140; yanlingzhi@suda.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: June 22, 2017
• Study Start: September 1, 2016
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 2, 2019

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)