Efficacy and Safety Evaluation of IM19 CAR-T Cell Therapy for MRD+ After Transplantation

Beijing Immunochina Medical Science & Technology

Status

Unknown

Conditions

Leukemia

Treatments

Biological: IM19 CAR-T

Study type

Interventional

Funder types

Industry

Identifiers

NCT04336501

YMCART20190423

Details and patient eligibility

About

Efficacy study about donor derived CD19-target T cell to treat B-ALL post hematopoietic stem cell transplantation

Full description

Allogeneic hematopoietic stem cell transplantation (allo-hsct) for the treatment of refractory recurrent acute b-lymphoblastic leukemia (b-all), the overall survival rate of 3 years after transplantation was about 10%. The overall survival rate at 3 years was about 70 percent. In the early stage, the investigators established the monitoring method of leukemia micro-residual disease, effectively screened out the high-risk group of recurrence, combined with the new relapse treatment method, successfully implemented the stratification and even personalized dry prediction of leukemia recurrence for the first time in the world, and reduced the recurrence rate of the high-risk group by 30%. However, the therapeutic targeting is not strong, and up to 30% of patients will develop graft versus host disease, which seriously affects the survival of patients. The use of CAR repair T cells (CAR T) to target CD19 in the treatment of refractory recurrent b-all was effective, and the use of CAR T in the treatment of recurrent b-all after transplantation did not increase the risk of GVHD. This clinical study mainly discussed the safety and efficacy of donor targeted cd19-t cells after allo-hsct in the treatment of acute b-lymphocytic leukemia with minimal residual disease. It is expected that the recurrence rate will be reduced while the incidence of acute GVHD after transplantation will not be increase

Enrollment

20 estimated patients

Sex

All

Ages

3 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

To be aged 3 to 65 years
It was consistent with the diagnosis of CD19+ B-All with MRD+ in allo- hsct transplantation
The immunotyping was determined to be CD19+ B-All
The T lymphocytes in the subjects were 100% donor T lymphocytes
No chemotherapy or antibody treatment was received 2 weeks before cell therapy
Left ventricular ejection fraction (LVEF) ≥50% and centerless inclusion were diagnosed by echocardiography
The subjects had no pulmonary active infection
Blood oxygen saturation at the fingertips ≥ 92%
Estimated survival of >3 months
ECOG physical condition level 0~1

Exclusion criteria

Unwilling to accept IM19 CAR-T cell therapy, do not agree to signInformed consent of subject
Subjects are allergic to the components of cellular products
Total serum bilirubin ≥ 2.0mg/dl、Serum albumin < 35g/L、ALT and AST were more than 3 times of the upper limit of the normal range. Blood creatinine ≥ 2.0mg/dl;Platelet < 20 x 109 / L
Subjects had activity level II-IV aGVHD, or activityModerate to severe cGVHD
The subjects had a severe failure to control the infection
Subject with known central nervous system leukemia (CNS2 or CNS3)
Subjects were treated with CAR T cells or DLT after transplantation
The subjects developed bone marrow failure syndrome after allo-hsct transplantation
The subjects had previously received other gene treatments
The subjects had a history of alcohol, drug use or mental illness
Subjects were enrolled in any other clinical investigator within 1 month prior to screening
Female subjects: 1) were pregnant/lactating, or 2) had a pregnancy plan during the study period,Or 3) fertile and unable to use effective contraception
The researchers believe there are other conditions that may not be appropriate for the study