The newly developed therapy belongs to the Dual CAR-T class and is a First-in-Human format, meaning it has never before been used in patients. Its uniqueness lies in the fact that the engineered T cells simultaneously recognize two tumor markers, CD38 and CD138, which are overexpressed on multiple myeloma cells. This dual-activation mechanism enables the CAR-T cells to destroy only malignant cells while largely sparing healthy tissue.
First-of-its-kind CAR-T product developed at Ichilov
At the Ichilov medical center, an innovative CAR-T cell therapy has been created and manufactured for patients with multiple myeloma — an aggressive cancer of the blood system. This marks a major breakthrough for Israeli and global oncohematology. The development was carried out at the Institute for Advanced Cell Therapy, where for the first time in the hospital’s history the entire pathway was completed: from a scientific concept to administering the therapy to a human patient.
Research that changed treatment approaches
The scientific part of the project was conducted in the Laboratory of Immunology and Cell Therapy under the leadership of Dr. Anat Gloverzon-Levin. The researchers designed the CAR-T cells so that immune activation occurs only when both target proteins are detected on the tumor surface. This approach significantly reduces the risk of severe side effects and increases the precision of the therapy.
Manufacturing and clinical preparation of the product were supervised by Shamrit Suleiman, Director of the Institute for Advanced Cell Therapy, and Dr. Jonathan Samo, Head of Development and Quality Control. An automated Cocoon platform was used to produce the cellular therapy — a closed-system bioreactor with single-use consumables that allows CAR-T cells to be grown in a sterile and fully controlled environment. This technology minimizes the risk of contamination and makes the process fast, reproducible, and safe.
Thanks to the combination of scientific expertise and modern manufacturing solutions, the transition from laboratory research to treatment of the first patient took less than one year — an exceptionally short timeframe for such complex cellular technologies.
Implementation of innovation at Ichilov
The first administration of the new Dual CAR-T therapy was carried out in the Hematology department of the Ichilov medical center under a compassionate-use program. The treatment was performed by Professor Yael Cohen, Head of the Multiple Myeloma Service, with the support of the department led by Professor Irit Avivi. Project coordination within the hematology service was managed by Dr. Noa Levanton-Shapir.
In 2023, a Phase I clinical trial was conducted involving several patients with relapsed or refractory multiple myeloma.
CAR-T therapy is a technology in which a patient’s own T lymphocytes are genetically modified to recognize specific proteins on tumor cells and selectively destroy them. This method has already demonstrated effectiveness in patients who do not respond to standard treatments and, in many cases, has led to long-term remissions and cures. The CAR-T concept was first developed by Professor Zelig Eshhar and is now considered one of the most revolutionary technologies in modern oncology.
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