Immunitybio Initiates Another Cell Therapy Trial With No Chemotherapy Needs

• The study builds on data from an early-stage study which evaluated CD19 CAR-NK cell therapy in combination with the Rituximab without Anktiva.
• Durable complete responses were observed in heavily pretreated patients with iNHL in the study, including Waldenström’s Macroglobulinemia, the company said.
• Last month, Immunitybio said that it recently met with the U.S. FDA to discuss its application for Anktiva plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors.

Immunitybio Inc. (IBRX) said on Monday that it has launched a mid-stage clinical study in patients with indolent B-cell non-Hodgkin lymphoma (iNHL) with no need for chemotherapy.

The company said that outpatient study will evaluate ImmunityBio’s novel, off-the-shelf cell therapy CD19 CAR-NK in combination with its other drug Anktiva and Rituximab, and will not require any lymphodepleting chemotherapy unlike conventional CAR-T cell therapies.

Why The Trial?

The study builds on data from an early-stage study which evaluated CD19 CAR-NK cell therapy in combination with the Rituximab without Anktiva. Durable complete responses were observed in heavily pretreated patients with iNHL in the study, including Waldenström’s Macroglobulinemia, the company said.

The new mid-stage study is designed to evaluate whether further stimulation of innate and adaptive immune responses may enhance the depth and durability of anti-tumor activity, Immunitybio said, while adding that the company is hopeful for Anktiva potentially augmenting the actions of the cell therapy and Rituximab.

The study will enroll patients with indolent NHL, including Waldenström’s Macroglobulinemia, who are relapsed or are refractory after at least two prior lines of therapy. Treatment will be provided without chemotherapy.

Anktiva Troubles

Last month, Immunitybio said that it recently met with the U.S. Food and Drug Administration to discuss its application for Anktiva plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary tumors.

The company had submitted the application in 2025 but was rejected and is now looking to resubmit it with more information. The company then said that it would submit the additional information within 30 days, and that the added information does not need a new trial.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around IBRX shares remained within the ‘bullish’ territory, while message volume remained at ‘high’ levels.

IBRX stock has gained about 90% over the past 12 months. 

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