Status:
UNKNOWN
A Feasibility and Safety Study of Dual Specificity CD38 and BCMA CAR-T Cell Immunotherapy for Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Multiple Myeloma
Eligibility:
All Genders
12-70 years
Phase:
PHASE1
PHASE2
Brief Summary
CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory Multiple Myeloma,however, a subset of patients relapse due to the loss of target in tumor cells.Dual Specific...
Detailed Description
1. PRIMARY OBJECTIVES: 1. To evaluate the feasibility and safety of dual specificity CD38 and BCMA CAR-T cells in patients with relapsed or refractory Multiple Myeloma. 2. To evaluate the durat...
Eligibility Criteria
Inclusion
- Male or female participant
- 12 Years to 70 Years (Child, Adult, Senior)
- Patient with relapsed or refractory Multiple Myeloma,multiple myeloma cell express CD38(over 50%) and BCMA (over 50%)
- Estimated life expectancy ≥ 12 weeks (according to investigator's judgement)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Adequate organ function
Exclusion
- Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease
- Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis
- Richter's syndrome
- Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD at the time of screening
- Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy
- Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), Prophylactic antibiotic, antiviral and antifungal treatment is permissible
- Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
- Patient has an investigational medicinal product within the last 30 days prior to screening
- Previous treatment with investigational gene or cell therapy medicine products
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
- Pregnant or nursing women
Key Trial Info
Start Date :
December 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 5 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03767751
Start Date
December 5 2018
End Date
December 5 2022
Last Update
December 7 2018
Active Locations (1)
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1
Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital
Beijing, China, 100853