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August 11, 2022

Gamida doses first subject in Phase I/II cell therapy trial for lymphomas

The Phase II expansion portion of the trial will assess GDA-201’s safety and efficacy in two cohorts of 63 subjects.

Gamida Cell has dosed the first subject in the Phase I/II clinical trial of natural killer (NK) cell therapy candidate GDA-201 to treat patients with follicular and diffuse large B cell lymphomas (FL and DLBCL).

The Phase I dose escalation portion of the trial will analyse the safety of cryopreserved, readily available formulation of GDA-201.

It will enrol individuals with FL, DLBCL/high-grade B-cell lymphoma, marginal zone lymphoma or mantle cell lymphoma. 

The Phase II expansion portion of the trial will assess the safety and efficacy of GDA-201 in two cohorts of 63 subjects with either FL or DLBCL. 

People with relapsed or refractory lymphoma following a minimum of two previous therapies, which may comprise chimeric antigen receptor T (CAR-T) or stem cell transplant, will be part of the trial sponsored by the company.

GDA-201 is an NK cell immunotherapy candidate intended to treat haematologic and solid tumours along with standard-of-care antibody treatments. 

It is the lead candidate in Gamida’s NAM-enabled NK cell pipeline and showed promising data in initial trials. 

Using the company’s NAM (nicotinamide) technology platform, GDA-201 boosts NK cell number and functionality to provide tumour cell killing properties and antibody-dependent cellular cytotoxicity.

Gamida Cell chief medical and scientific officer Ronit Simantov said: “We are excited to further advance the development of GDA-201, a NAM-enabled natural killer (NK) cell therapy candidate which we believe has the potential to be a new readily available, cryopreserved treatment option for cancer patients with relapsed/refractory lymphoma. 

“Our NK cells elicited an adaptive immune response in patients in the previous investigator-sponsored study with the fresh formulation of GDA-201, potentially leading to durable remissions.”

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.

Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.

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