Cord Blood Derived CAR-T Cells in Refractory/Relapsed B Cell Malignancies

Henan Cancer Hospital

Status and phase: Unknown; Phase 1

Conditions: B Cell Leukemia; Relapsed; Refractory; B Cell Lymphoma

Treatments: Biological: CAR-T cells

Study type: Interventional

Funder types: Other

Identifiers

NCT03881774

HenanCH CART 2-4

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 4 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

experimental arm

Experimental group

Description:

cord blood derived CAR T cells group

Treatment:

Biological: CAR-T cells