IND Cleared for New CAR T-Cell Therapy in Large B-Cell Lymphoma


KITE-363 is set to be investigated in a phase 1 clinical trial at the end of 2021.

The FDA has cleared Kite Pharma’s investigational new drug (IND) application of the chimeric antigen receptor (CAR) T-cell therapy KITE-363 for the treatment of large B-cell lymphoma (LBCL).1

The therapy from Kite, a Gilead subsidiary, is dual targeted against both CD19 and CD20. It is set to be evaluated in a multicenter phase 1 clinical trial (NCT04989803) that will initiate by the end of 2021.

“CD19-directed CAR T-cell therapies have transformed outcomes for patients with relapsed or refractory large B-cell lymphomas, and we are excited to continue our research on the next generation of potential cell therapy advances for patients,” said Francesco Marincola, MD, senior vice president and global head, cell therapy research, Kite, in a statement.1

The autologous T-cell therapy previously demonstrated its efficacy against both CD19 and CD20 in preclinical studies. The efficacy and safety of the investigational therapy will be assessed in the phase 1 trial. The trial will enroll adults with relapsed/refractory LBCL with at least 1 measurable lesion and adequate organ and bone marrow function. Prior treatment with CAR T-cell therapy is allowed.2 

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The trial’s primary outcomes will be adverse events (AEs) and dose-limiting toxicities during phase 1a (up to 28 days) and objective response rate (ORR) during phase 1b (up to 15 years). Secondary outcomes assessed will include AEs and serious AEs that occur up to 15 years after treatment, time to next treatment, complete response rate, durability of response, survival measures, and additional biomarkers of efficacy and safety.

“KITE-363, which targets two antigens highly expressed in large B-cell lymphomas–CD19 and CD20–is the next step forward in our research that may improve current treatments to help more patients,” Marincola added.1

Kite previously announced positive data from the ZUMA-7 trial (NCT03391466) of axi-cel (Yescarta), another CAR T-cell therapy for the treatment of relapsed/refractory LBCL.3 The therapy significantly improved event-free survival (EFS) by 60% (HR, 0.398; P <.0001) over chemotherapy plus stem cell transplant as a second-line treatment and therefore met the primary end point of the trial. Axi-cel also met its secondary end point of ORR. Additional analyses are planned for the ZUMA-7 trial but initial data revealed a trend of survival favoring patients treated with axi-cel.

Safety findings were similar to what had previously been seen with axi-cel in the treatment of patients with LBCL in the third-line treatment setting. Cytokine release syndrome that was grade 3 or higher in severity was reported by 6% of participants with a median onset of 3 days. Additionally, grade 3 or higher neurological effects were reported by 21% of participants. There were no new safety signals associated with the therapy as used as a second-line treatment.

“[Axi-cel] has been instrumental in transforming outcomes for patients with third-line LBCL. Our goal has always been to bring the benefit of CAR T-cell therapy to more patients, earlier in their treatment, where the potential for benefit may be even greater,” Christi Shaw, chief executive officer, Kite Pharma, said in a statement at that time.3 

1. Kite announces U.S. FDA clearance of investigational new drug application for KITE-363, a dual-targeting car t-cell therapy candidate for large b-cell lymphoma. News release. Kite Pharma. August 19, 2021.
2. Study evaluating the safety and efficacy of KITE-363 in participants with relapsed and/or refractory B-cell lymphoma. NIH US National Library of Medicine. August 4, 2021.
3. Kite announces Yescarta CAR T-cell therapy improved event-free survival by 60% over chemotherapy plus stem cell transplant in second-line relapsed or refractory large B-cell lymphoma. News release. Kite Pharma. June 28, 2021.
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