Refractory, Relapsed, B Cell Lymphoma, B Cell Leukemia
Conditions
Brief summary
Evaluation the safety and efficacy of cord blood-derived CAR-T cells in patients with relapsed/refractory B cell leukemia/lymphoma whose disease relapsed after autologous CAR-T cells therapy or who fail to preparation for autologous CAR-T cells
Detailed description
CAR-T cells therapy is the preferred option for relapsed/refractory B cell leukemia/lymphoma. However, some patients will relapse after CAR-T cells therapy, and because of previous multicycles chemotherapy it's very difficult to abtain enough lymphocytes for preparation of antologous CAR-T cells. The exploration of alternative source of lymphocytes for CAR-T cells preparation has important clinical implications for such patients. We evaluated the efficacy and safety of cord blood-derived CAR-T cells in such patients, and to explore effective treatment options for such patients.
Interventions
BIOLOGICALCAR-T cells
collecting cord blood for CAR-T cells culture; three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CAR-T cell with a dose of 0.5-3x106/kg
Sponsors
Henan Hualong Biotechnology Company
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
CAR-T cell group
Eligibility
Sex/Gender
ALL
Age
4 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* expected lifespan \>3 months * patients with refractory/relapsed B cell leukemia/lymphoma whose diseases relapse after autologous CAR-T cells or the preparation for autologous CAR-T cells fails * KPS \>70 * for patients with lymphoma, at least one measurable lesion according to RECIST 1.1 * enough function of heart, liver, kidney and bone marrow * no history of severy allergy * no other serious diseases that conflict with this plan * no other history of malignancy * no serious mental illness * patients and their families members agree to participate in this clinical study and sign the Informed Consent Form
Exclusion criteria
* pregnant or lactating women * vevere infectious or viral diseases * active hepatitis B or C viral hepatitis * Patients who have used large amounts of glucocorticoids or other immunosuppressive agents within the last 4 weeks * participated in other clinical studies in the past 3 months or who have been treated with other gene products; * others that other investigators consider not suitable for this clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| occurrence of study related adverse events | one year | safety of CAR-T cells |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | one year | from the date of enrollment to the first date of progression detected |
| overall survival | one year | from the date of enrollment to the date of death |
| copy number of CAR-T | six months | copy number of CAR-T in blood and bone marrow |
| objective response rate | three months | the proportion of patients with CR or PR |
Countries
China
Contacts
Primary ContactYongping Song, Dr.
Backup ContactQuanli Gao, Dr.
Outcome results
None listed