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.

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