Project description
Bringing a novel CART therapy to the clinic
T cells engineered to express a chimeric antigen receptor (CART) are emerging as powerful weapons against certain leukaemias. However, CAR T-cell strategies beyond B-cell malignancies have demonstrated toxicity associated with the lack of a therapeutic antigen. Scientists of the EU-funded IT4-TALL project have demonstrated the efficacy of a CD1a-specific CART approach against acute T lymphoblastic leukaemia. The therapeutic product has been patented and requires further clinical validation. The scope of the project is to undertake the necessary technical and biological improvements of the CD1a-specific CART product and manufacture it under GMP-grade conditions before obtaining regulatory approval.
Objective
Immunotherapy has revolutionized cancer treatment over the last decade. Adoptive cell immunotherapy with T-cells genetically redirected to a tumor-specific antigen using a chimeric antigen receptor (CAR) has achieved impressive response rates in advanced B-cell acute lymphoblastic leukemia (B-ALL). CAR T-cell strategies beyond B-cell tumors are, however, hampered by expected toxicities, owing to the lack of bona fide therapeutic and safe antigens. Indeed, there are no immunotherapeutic therapies (including CAR T-cells) approved for T-cell malignancies (T-ALL or T-cell lymphomas), as the shared expression of target antigens between CAR T-cells and T-blasts induces CAR T-cell fratricide and T-cell aplasia, leading to fatal immunodeficiency. We recently identified the CD1a antigen as a safe target for CD1a+ cortical T-ALL (coT-ALL), a major subgroup of T-ALL, and we have developed a novel CD1a-specific CAR. Results generated from my previous ERC-funded work (INFANTLEUKEMIA nº646903 and IT4-BALL nº811220) have just been protected by a European Patent (EP19382104.8; CARTs for the treatment of CD1a+ cancer). Our intellectual property rights coupled to our internationally-endorsed top-tier scientific publication are a major strength of our proof-of-principle demonstration that CD1a-directed CAR T-cells constitute a unique immunotherapy approach for coT-ALL. We propose to consolidate final technical-biological improvements and GMP-grade manufacturing of our CD1a-directed CAR T-cells in compliance with the requirements of the Spanish Regulatory Agency of Medicines and Medical Devices for advanced adoptive cellular therapies (AEMPS). Data from this project will be added to the final Investigational Medicinal Product Dossier (IMPD) of the CARCD1a T-cells to be submitted to AEMPS for regulatory approval to launch a pan-European open Phase Ib clinical trial for relapse/refractory coT-ALL in early 2022, ensuring social and health value of this innovative immunotherapy.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques.
- medical and health sciencesbasic medicinepharmacology and pharmacypharmaceutical drugs
- medical and health sciencesbasic medicineimmunologyimmunotherapy
- medical and health sciencesclinical medicineoncologyleukemia
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Programme(s)
Funding Scheme
ERC-POC - Proof of Concept GrantHost institution
08916 Badalona
Spain