CAR-T CD19 for Acute Myelogenous Leukemia With t 8:21 and CD19 Expression

Sheba Medical Center

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Biological: CAR-T CD19

Study type: Interventional

Funder types: Other

Identifiers

NCT04257175

6482-19-SMC

Details and patient eligibility

About

Chimeric antigen receptor (CAR-T) engineered T cells against the CD19 protein have been shown to be effective against acute lymphoma and lymphocytic leukemia and are approved by the US (FDA), European (EMA) and Health Basel.

However, little information exists on using CD19CAR for treatment of recurrent or irresponsible to previous treatment acute myeloid leukemia.

The proposed study will include patients with recurrent disease or those with disease irresponsible to common treatments and they will be treated with CAR-T CD19.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with recurrent acute myeloid leukemia (AML) including those after bone marrow transplantation or not responding to previous therapy, who have exhausted other approved relevant therapies such as chemotherapy protocols that are ineffective and with high toxicity, or FLT3 inhibitors in patients with FLT3 .

Exclusion criteria

• Heart disease including severe heart failure (NYHA III-IV), recent MI or CABG surgery (in previous six months), severe ventricular rhythm abnormalities, non ischemic heart disease, LVEF less than 45%
• Active involvement of CNS
• Active infection
• Pregnancy or lactation
• Graft versus host disease III-IV grade - Stroke or seizure in the last six months before treatment
• A positive result for the HIV infection (serum)
• Active hepatitis infection
• Life-threatening allergies to cyclophosphamide or fludarabine
• No informed consent signed by candidate
• Candidate enrolled in other study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Cyclophosphamide, Flodarabine,CAR-T cells

Experimental group

Description:

The appropriate participants will undergo lymhopheresis to collect lymphocytes from PBMC peripheral blood. CAR T CD19 cells will be produced. The participants will receive cyclophosphamide 300 mg / m² and flodarabine 30 mg / m² lymphodeplition intravenously daily for 3 days. The CAR-T CD19 cells will be given on the 5 to 7 day post lymphodeplition .

Treatment:

Biological: CAR-T CD19