Description:
This is a single centre、single arm、open-label,to investigate the safety and efficacy of anti-BCMA CAR T cells in patients with Relapsed and Refractory multiple myeloma.
This is a single centre、single arm、open-label,to investigate the safety and efficacy of anti-BCMA CAR T cells in patients with Relapsed and Refractory multiple myeloma.
Unknown status
Early Phase 1
| Drug | Synonyms | Arms |
|---|---|---|
| Anti-BCMA CAR T cells | Anti-BCMA CAR T cells |
Multiple myeloma(MM) is one of the most common malignant diseases in the blood system.There
is still no cure for the disease which only control the development of the disease in various
ways.CAR - T cells was taken in the form of genetic modification, and specific identified
target antigen monoclonal antibody of single variable region (scFv) expression in T cell
surface, and coupled with the activation of intracellular proliferation signal domain. The
study will follow a 3 + 3 design of dose-escalating cohorts. After a patient
enrolls,leukapheresis will be performed to obtain peripheral blood mononuclear cells which
will be sent to a manufacturing site to produce anti- BCMA CAR T cells. The cells will then
be returned to the investigational site and, after a standard chemotherapy based conditioning
regimen, will be administered to the patient. Treated patients will undergo serial
measurements of safety, tolerability and response.
In order to lay a foundation for the application of relapsed/refractory multiple myeloma
patients with CAR-T therapy,objects are refractory/ relapsed patients with multiple
myeloma,and plans to into the group of the number of cases in 20 cases.
| Name | Type | Description | Interventions |
|---|---|---|---|
| Anti-BCMA CAR T cells | Experimental | Total dose of 0.5-6 millions /kg cells will be administered at day -2, day -1 and day 0 by split dose (30%, 30% and 40% respectively). |
|
Inclusion Criteria:
1. Male or female, 18 to 70 years old (including 18 and 70 years old)
2. BCMA antigen diagnosed by pathology and histological examination was positive
3. ECOG ≤2,and the excepted survival ≥ 3 months
4. Patients with BCMA+ myeloma who received ≥ 1 line of chemoradiotherapy or tumor
relapsed
5. The main organs function is good; (1) liver function: ALT/AST<3 times normal value
upper limit (ULN) and total bilirubin <34.2 (mol/L); (2) renal function: creatinine
<220 mu /L,GFR > 30mL/min; (3) lung function: blood oxygen saturation is greater than
95%; (4) cardiac function: left ventricular ejection fraction (LVEF) is greater than
50%;
6. Platelets > 40 billion/L;
7. Patients without any anti-cancer treatment such as chemotherapy,radiotherapy,
immunotherapy( immunosuppressive drugs )within 2-4 weeks before, and the
treatment-related toxicity reaction ≤1 level prior to enrollment(except low toxicity
lose hair for example)
8. Venous channel is unobstructed, which can meet the needs of intravenous drip;
9. Voluntary informed consent is given, agree to follow the trial treatment and visit
plan.
Exclusion Criteria:
1. Patients with allergy to large molecules such as antibodies or cytokines;
2. More than 5mg of hormones (except patients with inhaled hormone) were used within 2 to
4 weeks prior enrollment;
3. Patients with severe autoimmune diseases or immunodeficiency diseases;
4. Patients treated with other immune cellular products (DC, CIK, T, NK, and CART
products with CD19 or other targets);
5. Patients with uncontrollable infectious disease in the first 4 weeks of treatment;
6. Active hepatitis B DNA > 1000copy/mL/ , hepatitis C positive, (HCV positive
resistance, HCV RNA positive);
7. Patients participated in other clinical trials within 6 weeks prior enrollment;
8. Patients with mental illness;
9. Patients with drug abuse/addiction and medical, psychological or social conditions may
interfere with the study or evaluate the results of the study;
10. Patients have alcohol dependence;
11. Pregnant or lactating women; Men or women who have a pregnancy plan within a year; The
patients cannot guarantee effective contraceptive measures during the trial period;
12. Patients had other conditions that were not appropriate for the group determined by
the researchers.
| Maximum Eligible Age: | 70 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | The safety of CAR T is evaluated to determine if CRS occurred |
| Time Frame: | Day 3-Year 2 after injection |
| Safety Issue: | |
| Description: | defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment |
| Phase: | Early Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Unknown status |
| Lead Sponsor: | Allife Medical Science and Technology Co., Ltd. |
June 18, 2018