C-CAR011 Treatment in Subjects With ALL After HSCT

Peking University

Status

Unknown

Conditions

Acute Lymphoblastic Leukemia(ALL)

Treatments

Biological: C-CAR011

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03327285

2017PHB033-01

CBMG-C2017004 (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment

40 estimated patients

Sex

All

Ages

15 to 65 years old

Volunteers

No Healthy Volunteers

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.