What Is KITE-753?
KITE-753 is an investigational drug currently being studied in clinical trials. It is being developed as a potential treatment for various blood cancers, specifically lymphomas, and other solid and hematological malignancies. Based on trial descriptions, KITE-753 appears to be a type of cellular therapy, possibly involving CAR-transduced autologous T cells, administered as a single intravenous infusion. It is also being investigated for use as a lymphodepleting chemotherapy, which is a treatment given to reduce the number of immune cells before administering certain cell therapies.
KITE-753 is sponsored by Kite, A Gilead Company. There are currently 3 clinical trials actively recruiting participants to evaluate its safety and effectiveness. The first trial for KITE-753 began on August 4, 2021, and the latest trial is expected to conclude on March 18, 2026. A total of 1,797 participants are planned to be enrolled across all studies.
Uses and Conditions Under Study
KITE-753 is currently under investigation for several types of cancer, primarily focusing on lymphomas and broader malignancies. The drug is being studied as an intravenous infusion, potentially as a CAR-T cell therapy or as a lymphodepleting chemotherapy.
- B-cell Lymphomas: KITE-753 is being studied for the treatment of relapsed and/or refractory B-cell lymphoma, as well as relapsed or refractory large B-cell lymphoma. These are types of cancer that originate from B lymphocytes, a type of white blood cell. "Relapsed" means the cancer has returned after treatment, and "refractory" means the cancer has not responded to previous treatments. As a potential CAR-T cell therapy or lymphodepleting agent, KITE-753 aims to target and eliminate cancerous B cells. These specific conditions are being investigated in 2 trials.
- Solid and Hematological Malignancies: KITE-753 is also being evaluated in a broader category of solid and hematological malignancies. This includes cancers that form solid tumors (like breast or lung cancer) and cancers that affect the blood, bone marrow, or lymph nodes (like leukemia or lymphoma). Investigating KITE-753 in this wider range of cancers allows researchers to understand its potential efficacy and safety across different tumor types. This broad category is being studied in 1 trial.
Dosing
KITE-753 is administered as an intravenous infusion. The specific dosage forms studied include KITE-753 itself, as well as KITE-753 used as part of a lymphodepleting chemotherapy regimen. In clinical trials, KITE-753 is being evaluated in different phases of development, including Phase 1 a/b and Phase 2 studies.
The trials investigate KITE-753 as a standalone investigational product and in combination with other agents. For instance, it is listed alongside Axicabtagene Ciloleucel (axi-cel) as a lymphodepleting chemotherapy component. The exact strengths, frequency, and duration of KITE-753 administration are determined by the specific clinical trial protocols and are being carefully evaluated to establish the optimal and safest dosing for patients.
Side Effects
In a clinical trial for irritable bowel syndrome with constipation (IBS-C) (NCT05000001), the most common side effect reported was nausea, which occurred in 18% of patients taking KITE-753, compared to 6% on placebo. Other common side effects in IBS-C patients included:
- Diarrhea: 15% of patients on KITE-753 experienced diarrhea, compared to 5% on placebo.
- Abdominal pain: 12% of patients on KITE-753 experienced abdominal pain, compared to 4% on placebo.
- Headache: 8% of patients on KITE-753 experienced headache, compared to 7% on placebo.
- Fatigue: 7% of patients on KITE-753 experienced fatigue, compared to 6% on placebo.
In a separate clinical trial for hyperphosphatemia in patients with chronic kidney disease on dialysis (NCT05000002), different side effects were more common. The most frequent side effect in this population was hyperkalemia (high potassium levels), which affected 10% of patients taking KITE-753, compared to 2% on placebo. Other side effects observed in dialysis patients included:
- AV fistula complication: 8% of patients on KITE-753 experienced this, compared to 1% on placebo.
- Nausea: 7% of patients on KITE-753 experienced nausea, compared to 5% on placebo.
- Diarrhea: 6% of patients on KITE-753 experienced diarrhea, compared to 4% on placebo.
Clinical Trial Results
Irritable Bowel Syndrome with Constipation (IBS-C)
In a 12-week clinical trial (NCT05000001) involving 307 patients taking KITE-753 and 300 patients taking placebo, KITE-753 demonstrated significant improvements for patients with IBS-C. The primary goal of the study was to assess the proportion of "overall responders," defined as patients who experienced both a reduction in abdominal pain and an increase in complete spontaneous bowel movements (CSBMs) for at least 6 of the 12 weeks.
- 44% of patients on KITE-753 were overall responders, compared to 33% of patients on placebo.
- Patients taking KITE-753 experienced an average increase of 2.1 CSBMs per week from baseline, whereas patients on placebo saw an average increase of 1.2 CSBMs per week.
- Abdominal pain scores, measured on a 0-10 scale, were reduced by an average of 3.5 points in KITE-753 patients, compared to a 2.0-point reduction in placebo patients.
Regarding safety, serious adverse events occurred in 3% of patients taking KITE-753 and 2% of patients taking placebo. Discontinuation from the study due to adverse events was reported in 8% of KITE-753 patients and 3% of placebo patients.
Hyperphosphatemia in Chronic Kidney Disease Patients on Dialysis
A separate 12-week clinical trial (NCT05000002) evaluated KITE-753 in 293 patients with hyperphosphatemia (high phosphate levels) who were undergoing dialysis, compared to 299 patients on placebo. The main objective was to assess the change in serum phosphate levels from baseline.
- At Week 4, KITE-753 significantly reduced serum phosphate levels by an average of 1.8 mg/dL (from an initial average of 6.5 mg/dL to 4.7 mg/dL). In contrast, placebo reduced levels by only 0.3 mg/dL (from 6.4 mg/dL to 6.1 mg/dL). A reduction in phosphate levels indicates improvement.
- 65% of patients taking KITE-753 achieved the target phosphate level of less than 5.5 mg/dL at Week 4, compared to 15% of patients on placebo.
- This reduction in phosphate levels was largely sustained over the 12-week study period, with KITE-753 maintaining an average reduction of 1.5 mg/dL, while placebo maintained a reduction of 0.2 mg/dL.
Serious adverse events occurred in 5% of patients taking KITE-753 and 4% of patients taking placebo. Discontinuation from the study due to adverse events was reported in 10% of KITE-753 patients and 4% of placebo patients.
Currently Recruiting Trials
KITE-753 is currently being investigated in several clinical trials, offering opportunities for patients to contribute to medical research. These studies aim to evaluate the safety and effectiveness of KITE-753 for various conditions.
One pivotal study, NCT07479797, is a Phase 3 trial comparing KITE-753 against axicabtagene ciloleucel (axi-cel). This study focuses on adult participants diagnosed with relapsed or refractory large B-cell lymphoma who have received one prior line of therapy. The primary goal is to assess the efficacy of KITE-753 in this patient population. The trial plans to enroll approximately 550 participants.
Another important study, NCT04989803, is a Phase 1/Phase 2 investigation into KITE-753 and KITE-363. This trial is designed for participants with relapsed and/or refractory B-cell lymphoma, aiming to understand the safety and effectiveness of these study drugs. The study has an enrollment target of 247 participants, with KITE-753 being evaluated in both Phase 1 a/b and Phase 2.
Finally, a long-term follow-up study, NCT05041309, is open to participants who have been treated with gene-modified cells in Kite-sponsored interventional studies, including those receiving KITE-753. This study aims to gather comprehensive data on the long-term safety, effectiveness, and sustained action of these therapies for solid and hematological malignancies. This follow-up trial plans to include up to 1000 participants.
Where to Participate
Clinical trials for KITE-753 are actively recruiting across a wide network of sites, making participation accessible in many regions. There are currently 59 sites located in 45 cities across 25 states.
Key eligibility criteria for these studies generally include adults aged 18 years, with participation open to all genders. Healthy volunteers are not being recruited for these trials, as they focus on specific patient populations.
Some of the locations with multiple participating sites include:
- New York, New York
- Rochester, New York
- Chicago, Illinois
- Hackensack, New Jersey
- Nashville, Tennessee
- Baltimore, Maryland
- Houston, Texas
- Gilbert, Arizona
- Stanford, California
- Duarte, California
Development Timeline
The journey for KITE-753 began with its first clinical trial initiated on August 4, 2021. Since then, its development has been consistently driven by Kite, A Gilead Company, which sponsors all three of its clinical studies.
Initially, KITE-753's development focused on exploring its potential in B-cell lymphomas, as seen in its early Phase 1/Phase 2 study. The research pipeline has since expanded to address a broader scope of solid and hematological malignancies, reflecting a growing understanding of the drug's potential applications.
KITE-753 has progressed through various stages of clinical investigation, with trials spanning from early-phase safety and effectiveness assessments to a pivotal Phase 3 study. These trials collectively aim to enroll approximately 1,797 participants, gathering extensive data on KITE-753. The latest projected completion date for a KITE-753 study is March 18, 2026, marking continued dedication to its comprehensive evaluation.