Status:
UNKNOWN
A Feasibility and Safety Study of Concomitant Therapy With Allo-CAR-T Cells and Allo-HSCT in Patients With Relapse or Refractory Leukemia
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
B Cell Leukemia
Eligibility:
All Genders
12-60 years
Phase:
PHASE1
Brief Summary
Allogenic hematopoietic stem cell transplant (Allo-HSCT) is routinely used for treatment of aggressive hematological malignancies. The biological foundation of allo-HSCT is the graft-versus-leukemia (...
Detailed Description
1. PRIMARY OBJECTIVES: 1. To evaluate the feasibility and safety of donor-derived HSCT following donor-derived CD19/22 bispecific CAR-T cells or CD19-directed CAR-T cells in patients with relapsed...
Eligibility Criteria
Inclusion
- Male or female participant
- 12 Years to 60 Years
- Patient with relapsed or refractory B-cell leukemia or lymphoma
- 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 :
October 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03463928
Start Date
October 8 2017
End Date
December 1 2019
Last Update
March 13 2018
Active Locations (1)
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1
Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital
Beijing, China, 100853