B Cell Leukemia Clinical Trial
Official title:
Phase I Study to Evaluate Treatment of Relapsed or Refractory Leukemia With Donor-derived HSCT Following Donor-derived CD19/22 Bispecific CAR-T Cells or CD19-directed CAR-T Cells
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 (GVL) effect, which is primarily mediated by donor T cells present in the graft and is able to eradicate malignant B cells either CD19+ or CD19-. Relapse following an allo-HSCT remains a major challenge in the treatment of B-ALL. CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory B-cell malignancies; however, a subset of patients relapse due to the loss of CD19 in tumor cells. Co-infusion of donor-derived CD19/22 bispecific CAR-T cells or CD19-directed CAR-T cells and donor-derived-HSCT has the potential to combine the CAR-T cell mediated targeted elimination of CD19 expressing B cells with GVL effect, which could have clear advantages in reducing the risk of relapse and the evolution of CD19− escape variants or clonally related malignancies in other lineages. Therefore, a complete and durable tumor responses induced by this immunotherapy could be expected.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | December 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Male or female participant 2. 12 Years to 60 Years 3. Patient with relapsed or refractory B-cell leukemia or lymphoma 4. Estimated life expectancy = 12 weeks (according to investigator's judgement) 5. Eastern Cooperative Oncology Group (ECOG) performance status = 1 6. Adequate organ function Exclusion Criteria: 1. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease 2. Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis 3. Richter's syndrome 4. Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD at the time of screening 5. Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy 6. Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), Prophylactic antibiotic, antiviral and antifungal treatment is permissible 7. Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening 8. Patient has an investigational medicinal product within the last 30 days prior to screening 9. Previous treatment with investigational gene or cell therapy medicine products 10. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary 11. Pregnant or nursing women |
Country | Name | City | State |
---|---|---|---|
China | Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese PLA General Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Severe/Adverse Events as a Measure of Safety and Tolerability | 24 weeks | ||
Secondary | Overall remission rate (ORR) = CR + CRi | 24 weeks | ||
Secondary | Six-month Overall survival | 24 weeks | ||
Secondary | Six-month Progression free survival | 24 weeks |
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