Description:
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.
Title
- Brief Title: Anti-CD19/BCMA Bispecific CAR-T Cell Therapy for R/R MM
- Official Title: Clinical Study of Anti-CD19/BCMA Bispecific Chimeric Antigen Receptors (CARs) T Cell Therapy for Relapsed and Refractory Multiple Myeloma
Clinical Trial IDs
- ORG STUDY ID:
SHZS-MM002
- NCT ID:
NCT03706547
Conditions
- Multiple Myeloma in Relapse
- Multiple Myeloma Progression
Interventions
Drug | Synonyms | Arms |
---|
anti-CD19/BCMA CAR-T cells | | anti-CD19/BCMA CAR-T cells |
Fludarabine | | anti-CD19/BCMA CAR-T cells |
Cyclophosphamide | | anti-CD19/BCMA CAR-T cells |
Purpose
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.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
anti-CD19/BCMA CAR-T cells | Experimental | Chemotherapy with a classic combination with fludarabine and cyclophosphamide;
Administration with anti-CD19/BCMA CAR-T cells in the BCMA-positive multiple myeloma patients. | - anti-CD19/BCMA CAR-T cells
- Fludarabine
- Cyclophosphamide
|
Eligibility Criteria
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
Maximum Eligible Age: | 70 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 |
Secondary Outcome Measures
Measure: | Overall remission rate defined by the standard response criteria for myeloma for each arm |
Time Frame: | 8 weeks |
Safety Issue: | |
Description: | Overall remission rate defined by the standard response criteria for myeloma for each arm |
Measure: | Duration of CAR-positive T cells in circulation |
Time Frame: | 6 months |
Safety Issue: | |
Description: | Duration of CAR-positive T cells in circulation |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | Peng Liu |
Last Updated
October 16, 2018