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

Phase 2

Recruiting

• Conditions: Acute Myeloid Leukemia
• Interventions: Biological: CAR-T CD19

• Registration Number: NCT04257175
• Lead Sponsor: Sheba Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-05
• Study Start: 2020-02-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cyclophosphamide, Flodarabine,CAR-T cells	CAR-T CD19	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 .

Primary Outcome Measures

Name	Time	Method
The change in the chromosomal translocations and aberrations	Within two years from the introduction of the CAR-T CD19	Will be evaluated by cytogenetics and FISH
The change in the peripheral blood counts and differential	Within two years from the introduction of the CAR-T CD19	Will be evaluated by Coulter counter
The change in the measurable residual disease	Within two years from the introduction of the CAR-T CD19	Will be evaluated by PCR
The change in the antigen expression on the leukemic blasts	Within two years from the introduction of the CAR-T CD19	Will be evaluated by FACS

Trial Locations

Locations (1)

Chaim Sheba Medical Center; 🇮🇱 Ramat Gan, Israel