C-CAR011 Treatment in Subjects With ALL After HSCT

NCT ID: NCT03327285

Last Updated: 2020-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2021-04-30

Brief Summary

This is a single-center, prospective clinical study evaluating safety and efficacy of C-CAR011 treatment in subjects with ALL after HSCT

Detailed Description

A study evaluating safety and efficacy of CBM.CD19-targeted chimeric antigen receptor T cells (C-CAR011) treatment in subjects with acute lymphoblastic leukemia(ALL) after hematopoietic stem cell transplantation（HSCT）. The amount of cells received：1.0-5.0×10^6CAR+T cells/kg

Conditions

Acute Lymphoblastic Leukemia(ALL)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

C-CAR011

The amount of cells received：1.0-5.0×10\^6 CAR+T cells/kg

Group Type: EXPERIMENTAL

C-CAR011

Intervention Type: BIOLOGICAL

CBM.CD19-targeted chimeric antigen receptor T cells(C-CAR011)

Interventions

C-CAR011

CBM.CD19-targeted chimeric antigen receptor T cells(C-CAR011)

Intervention Type: BIOLOGICAL

Other Intervention Names

Anti-CD19 chimeric antigen receptor T cells (C-CAR011)

Eligibility Criteria

Inclusion Criteria

• Age 15-65 years old, male or female.
• Volunteered to participate in this study and signed informed consent.
• Meet the two populations above.
• Histologically diagnosed as CD19+B-ALL.
• 100% T lymphocytes of donor.
• Treatment without chemotherapy and antibody therapy within 2 weeks prior to C-CAR011 therapy.
• Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion and clinically significant arrhythmias.
• Baseline oxygen saturation ≧ 92% on room air and with normal pulmonary function, no evidence of active lung infection.
• Expected survival ≧ 3 months.
• Eastern cooperative oncology group (ECOG) performance status of 0 or 1.

Exclusion Criteria

• History of allergy to cellular products.
• Any kind of these laboratory testing: serum total bilirubin≧2.0mg/dl, serum albumin<35g/L, ALT, AST≧3×ULN, serum creatinine≧2.0mg/ dl,platelets<20×109/L.
• The subjects had active aGVHD with II-IV degrees (Glucksberg degrees) or active moderate to severe cGVHD.
• Severe uncontrolled infection (mycotic, bacterial, virus and so on).
• Any central nervous system leukemia(CNS2, CNS3) , with insensitive to intrathecal injection of or radiotherapy of head/spine; but effectively controlled cases will be eligible.
• The subjects were treated CART cells or DLI after HSCT.
• Bone marrow failure syndrome（BMF） after allogeneic hematopoietic stem cell transplantation.
• Any genetically modified T cell therapy.
• History of heavy drinking, drug taking or mental disease.
• Participated in any other clinical trial within one month prior to enrollment.
• Women who are pregnant or lactating or have breeding intent in 6 months.
• The investigators believe that any increase in the risk of the subject or interference with the results of the trial.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai AbelZeta Ltd.

INDUSTRY

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaojun Huang,MD

Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaojun Huang

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University Institute of Hematology

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

CBMG-C2017004

Identifier Type: OTHER

Identifier Source: secondary_id

2017PHB033-01

Identifier Type: -

Identifier Source: org_study_id