Cord Blood Derived CAR-T Cells in Refractory/Relapsed B Cell Malignancies
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: experimental arm cord blood derived CAR T cells group |
Biological: CAR-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
Other Names:
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Outcome Measures
Primary Outcome Measures
- occurrence of study related adverse events [one year]
safety of CAR-T cells
Secondary Outcome Measures
- objective response rate [three months]
the proportion of patients with CR or PR
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Henan Cancer Hospital | Zhengzhou | Henan | China | 450000 |
| 2 | Henan Cancer Hospital | Zhengzhou | Henan | China |
Sponsors and Collaborators
- Henan Cancer Hospital
- Henan Hualong Biotechnology Company
Investigators
- Study Chair: Yongping Song, Dr., Henan Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HenanCH CART 2-4