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

NCT ID: NCT03881774

Last Updated: 2019-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-27

Study Completion Date

2022-01-31

Brief Summary

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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

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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.

Conditions

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Refractory Relapsed B Cell Lymphoma B Cell Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

CAR-T cell group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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experimental arm

cord blood derived CAR T cells group

Group Type EXPERIMENTAL

CAR-T cells

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

Other Intervention Names

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cord blood derived CAR-T cells

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henan Hualong Biotechnology Company

UNKNOWN

Sponsor Role collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yongping Song, Dr.

Role: STUDY_CHAIR

Henan Cancer Hospital

Locations

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Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongping Song, Dr.

Role: CONTACT

+86-37165587795

Quanli Gao, Dr.

Role: CONTACT

+86-37165587483

Facility Contacts

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Quanli Gao, M.D

Role: primary

+86-15038171966

Lu Han, M.D

Role: backup

+86-13838583031

Yongping Song, M.D

Role: primary

+86-37165587795

Other Identifiers

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HenanCH CART 2-4

Identifier Type: -

Identifier Source: org_study_id

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