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Anti-CD19/BCMA Bispecific CAR-T Cell Therapy for R/R MM

Sponsor
Peng Liu (Other)
Overall Status
Unknown status
CT.gov ID
NCT03706547
Collaborator
Hrain Biotechnology (Other), Shanghai East Hospital (Other)
20
Enrollment
1
Location
1
Arm
37.1
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory multiple myeloma.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Primary Objectives

  1. To determine the feasibility ad safety of anti-CD19/BCMA CAR-T cells in treating patients with BCMA-positive multiple myeloma.

Secondary Objectives

  1. To access the efficacy of anti-CD19/BCMA CAR-T cells in patients with multiple myeloma.

  2. To determine in vivo dynamics and persistency of anti-CD19/BCMA CAR-T cells.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study of Anti-CD19/BCMA Bispecific Chimeric Antigen Receptors (CARs) T Cell Therapy for Relapsed and Refractory Multiple Myeloma
Anticipated Study Start Date :
Oct 30, 2018
Anticipated Primary Completion Date :
Jul 1, 2020
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: anti-CD19/BCMA CAR-T cells

Chemotherapy with a classic combination with fludarabine and cyclophosphamide; Administration with anti-CD19/BCMA CAR-T cells in the BCMA-positive multiple myeloma patients.

Biological: anti-CD19/BCMA CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs

Drug: Fludarabine
30mg/m2/d

Drug: Cyclophosphamide
300mg/m2/d

Outcome Measures

Primary Outcome Measures

  1. Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 [6 months]

    Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0

Secondary Outcome Measures

  1. Overall remission rate defined by the standard response criteria for myeloma for each arm [8 weeks]

    Overall remission rate defined by the standard response criteria for myeloma for each arm

  2. Duration of CAR-positive T cells in circulation [6 months]

    Duration of CAR-positive T cells in circulation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Expected survival > 12 weeks

  • Diagnosis of Multiple Myeloma by IMWG updated criteria (2014)

  • Pathology demonstrated that BCMA-poitive malignant plasma cells exited in bone marrow or plamacytoma

  • Exited measurable lesions and in accordance with one of the following test indicators: serum M protein≥1 g/dl; urine M protein≥200 mg/24h; serum free light chain≥10 mg/dl; diagnosis of plasmacytoma by biopsy

  • The criteria for relapsed and refractory multiple myeloma: patients previously received at least 3 different prior treatment regimens for multiple myeloma, including protein inhibitors (eg: Bortezomib), and immunomodulator (eg: Revlimid), and have disease progression in the past 60 days

  • At least 90 days after stem cell transplantation

  • Clinical performance status of ECOG score 0-2

  • Creatinine≤2.0 mg/dl

  • Bilirubin≤2.0 mg/dl

  • The ALT/AST value is lower than 2.5-fold of normal value

  • Accessible to intravenous injection, and no white blood cell collection contraindications

  • Sexually active patients must be willing to utilize one of the more effective birth control methods for 30 days after the CTL infusion. Male partner should use a condom

  • 5mg/day dose of Prednisone or other equivalent steroid hormone drugs (eg: Dexamethasone) were not used for two weeks before apheresis and CAR-T infusion

  • Able to understand and sign the Informed Consent Document.

Exclusion Criteria:

  • Patients with symptoms of central nervous system

  • Patients with second malignancies in addition to multiple myeloma

  • Active hepatitis B or C, HIV infections

  • Any other active diseases could affect the enrollment of this trial

  • Long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment

  • Patients with organ failure

  • Women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy

  • A history of mental illness and poorly controlled

  • Women of child-bearing potential who are not willing to practice birth control from the time of enrollment on this study and for 2 months after receiving the preparative regimen. Women of child bearing potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion

  • Patients who are accounted by researchers to be not appropriate for this test

  • Subjects suffering disease affects the understanding of informed consent or complying with study protocol

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Hematology ,Fudan University Zhongshan Hospital Shanghai China 200032

Sponsors and Collaborators

  • Peng Liu
  • Hrain Biotechnology
  • Shanghai East Hospital

Investigators

  • Principal Investigator: Peng Liu, M.D. & Ph.D., Shanghai Zhongshan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Peng Liu, Professor, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT03706547
Other Study ID Numbers:
  • SHZS-MM002
First Posted:
Oct 16, 2018
Last Update Posted:
Oct 16, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Cyclophosphamide
Fludarabine

Study Results

No Results Posted as of Oct 16, 2018