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

Phase 1

• Conditions: Refractory; Relapsed; B Cell Lymphoma; B Cell Leukemia
• Interventions: Biological: CAR-T cells

• Registration Number: NCT03881774
• Lead Sponsor: Henan Cancer Hospital

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.

Study Timeline

• Study Start: 2019-02-27
• Status Verified: 2019-03
• Study First Submitted: 2019-03-16
• Study First Submitted QC: 2019-03-16
• Study First Posted: 2019-03-19
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21
• Primary Completion: 2021-01-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental arm	CAR-T cells	cord blood derived CAR T cells group

Primary Outcome Measures

Name	Time	Method
occurrence of study related adverse events	one year	safety of CAR-T cells

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China