Clinical trial NCT03881774: Cord Blood Derived CAR-T Cells in Refractory/Relapsed B Cell Malignancies
Official title: Clinical Study of Cord Blood Derived CAR-T Cells in Patients With Refractory/Relapsed B Cell Leukemia/Lymphoma Who Are Failed for Autologous CAR-T Cells or Autologous CAR-T Can Not be Prepared
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Refractory
Relapsed
B Cell Lymphoma
B Cell Leukemia
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Henan Hualong Biotechnology Company
First posted: 2019-03-19
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: CAR-T cell group
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: occurrence of study related adverse events
timeFrame: one year
Secondary outcomes:
measure: objective response rate
timeFrame: three months
measure: progression-free survival
timeFrame: one year
measure: overall survival
timeFrame: one year
measure: copy number of CAR-T
timeFrame: six months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Yongping Song, Dr.
role: STUDY_CHAIR
References: