KITE-197 for Large B-cell Lymphoma

Not currently recruiting at 12 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Kite, A Gilead Company

Must not be taking: CD19 antibodies, Bendamustine, CAR therapy

Disqualifiers: Other malignancy, Richter's transformation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called KITE-197 for individuals with large B-cell lymphoma that has returned or not responded to other treatments. The first phase will determine the safest dosage, while the second phase will evaluate the treatment's effectiveness. Individuals with relapsed or refractory large B-cell lymphoma, who have at least one measurable tumor and normal organ function, might be suitable candidates. Participants will undergo chemotherapy before receiving a dose of KITE-197, a treatment involving modified immune cells. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for the KITE-197 trial?

The trial information does not specify whether you need to stop taking your current medications. However, certain prior treatments and conditions are listed as exclusion criteria, so it's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that KITE-197 is likely to be safe for humans?

Research shows that CAR T cell therapies, such as KITE-197, hold promise for treating B cell cancers. Earlier studies with similar therapies found they can lead to long-term remission for some patients. Most people tolerated the treatment well, though some experienced side effects. Common issues included flu-like symptoms and fatigue. Serious side effects, though less common, might affect the nervous system or trigger strong immune reactions. As KITE-197 remains under investigation, its safety and optimal dosage are still being studied. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for large B-cell lymphoma, which often involve chemotherapy or stem cell transplants, KITE-197 offers a novel approach by using chimeric antigen receptor (CAR) T-cell therapy. This treatment involves reprogramming a patient's own T-cells to target and destroy cancer cells more precisely. Researchers are excited about KITE-197 because it has the potential to be more effective and less toxic than traditional therapies, offering hope for patients with relapsed or refractory cases who have limited options. This targeted approach could lead to better outcomes and fewer side effects, making it a promising option in the fight against this aggressive form of lymphoma.

What evidence suggests that KITE-197 might be an effective treatment for large B-cell lymphoma?

Research has shown that CD19-targeted CAR T cell therapies, such as KITE-197, hold promise for treating B cell cancers, including large B-cell lymphoma. These treatments can result in extended periods without cancer recurrence. Previous studies on similar therapies have demonstrated good survival rates and few long-term side effects. In this trial, participants will receive KITE-197, a therapy that uses specially modified immune cells to locate and destroy cancer cells, following lymphodepleting chemotherapy with cyclophosphamide and fludarabine. Although more research is needed to confirm its effectiveness specifically for large B-cell lymphoma, current evidence suggests potential benefits. ^{1 3 5 6 7}

Who Is on the Research Team?

Kite Study Director

Principal Investigator

Kite, A Gilead Company

Are You a Good Fit for This Trial?

This trial is for individuals with relapsed or refractory Large B-cell Lymphoma who have at least one measurable lesion and proper organ and bone marrow function. It's not suitable for those who don't meet these health requirements.

Inclusion Criteria

My large B-cell lymphoma has returned or is not responding to treatment.

You have at least one lesion that can be measured.

My organs and bone marrow are working well.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a (Dose Escalation)

Participants receive lymphodepleting chemotherapy followed by a single target starting dose of KITE-197. Additional participants are enrolled based on dose limiting toxicities observed.

Duration not specified

Phase 1b (Dose Expansion)

Participants receive lymphodepleting chemotherapy followed by a single dose of KITE-197 at a tolerable dose level.

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Long-term follow-up

Participants transition to a separate Kite long-term follow-up study for the remainder of the 15-year follow-up period.

What Are the Treatments Tested in This Trial?

Interventions

• Cyclophosphamide
• Fludarabine
• KITE-197

Trial Overview The study tests KITE-197, alongside Cyclophosphamide and Fludarabine, in two phases: Phase 1a focuses on safety, tolerability, and dosing; Phase 1b assesses the effectiveness of KITE-197 at the recommended dose by looking at remission rates.

How Is the Trial Designed?

Group I: KITE-197 Experimental Treatment 3 Interventions

Phase 1a (Dose Escalation): Participants with r/r large B-cell lymphoma will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single target starting dose of KITE-197 chimeric antigen receptor (CAR) transduced autologous T cells. Based on dose limiting toxicities (DLTs) observed in the first cohort, additional participants will be enrolled and administered escalating dose of KITE-197. Phase 1b (Dose Expansion): After completion of dose escalation, additional participants with r/r B-cell lymphoma across different disease indications will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single dose of KITE-197 CAR-transduced autologous T cells at 1 or more dose-level deemed to be tolerable.

Who Is Running the Clinical Trial?

Kite, A Gilead Company

Lead Sponsor

Trials

45

Recruited

4,300+

Published Research Related to This Trial

Recent advancements in treating diffuse large B cell lymphoma have led to improved patient outcomes, particularly through dose-dense chemotherapy regimens and the combination of rituximab with chemotherapy, resulting in higher response rates and longer survival.

While low-risk patients have seen significant improvements, high-risk patients still require more effective strategies, potentially through better understanding of genetic factors that contribute to treatment resistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current strategies for the treatment of diffuse large B cell lymphoma. Coiffier, B.[2019]

Only 40% of patients with aggressive non-Hodgkin's lymphoma achieve long-term remission with standard CHOP chemotherapy, highlighting the need for improved treatment strategies.

Current research is focusing on personalized treatment approaches, including the use of prognostic factors to identify patients who may benefit from aggressive therapy, as well as integrating novel therapies like immunotherapy and radioimmunotherapy to enhance outcomes, especially for elderly patients who are more vulnerable to intensive treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current treatment options in aggressive lymphoma. Marcus, R.[2019]

A Paediatric Strategy Forum highlighted the need for focused drug development for children with B-cell malignancies, particularly emphasizing the importance of creating effective treatments for relapsed and refractory cases, as current frontline therapies are successful but come with significant toxicity.

Clinicians agreed that therapies like CAR T-cells, T-cell engagers, and antibody drug conjugates show the most promise for treating relapsed B-cell malignancies, although the lengthy production time for CAR T-cells limits their immediate use in acute situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ACCELERATE and European Medicine Agency Paediatric Strategy Forum for medicinal product development for mature B-cell malignancies in children. Pearson, ADJ., Scobie, N., Norga, K., et al.[2020]

In a phase II trial involving 25 adults with newly diagnosed Burkitt's lymphoma, the combination of liposomal doxorubicin and rituximab achieved a remarkable overall response rate of 100%, with 92% of patients reaching complete remission.

At a median follow-up of 34 months, the 2-year progression-free survival rate was 80% and overall survival rate was 84%, particularly notable for high-risk, HIV-negative patients who had even better outcomes with 84% PFS and 89% OS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicenter phase II study incorporating high-dose rituximab and liposomal doxorubicin into the CODOX-M/IVAC regimen for untreated Burkitt's lymphoma. Evens, AM., Carson, KR., Kolesar, J., et al.[2022]

The BLK88 treatment protocol, which includes high doses of chemotherapy and CNS prophylaxis, showed promising results in treating pediatric B cell non-Hodgkin's lymphoma and acute lymphoblastic leukemia, with 4 out of 6 patients in advanced stages remaining in complete remission after treatment.

Despite some side effects like neutropenia and liver dysfunction, which were manageable, the BLK88 protocol proved to be more effective than historical controls, where all patients in advanced stages relapsed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Chemotherapy for B lymphoid malignancy in childhood--results in BLK88 protocol]. Hibi, S., Fujiwara, F., Hashida, T., et al.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/show/NCT06079164

Study of KITE-197 in Participants With Relapsed or ... The goal of Phase 1a of this clinical study is to learn more about the safety, tolerability and dosing of study drug KITE-197, in participants with relapsed or ...

2. ashpublications.org ashpublications.org/bloodadvances/article/doi/10.1182/bloodadvances.2025016778/546741/Comparative-real-world-outcomes-of-CD19-directed

Comparative real-world outcomes of CD19-directed CAR T ... Tisa-cel is associated with inferior survival, whereas liso-cel and axi-cel show similar survival outcomes. Liso-cel exhibits the most favorable toxicity ...

3. gileadclinicaltrials.com gileadclinicaltrials.com/study?nctid=NCT06079164

Study of KITE-197 in Participants With Relapsed or ... A Phase 1 Open-label, Single Arm, Multicenter Study Evaluating the Safety and Efficacy of KITE-197 in Subjects With Relapsed or Refractory Large B-cell Lymphoma

4. nature.com nature.com/articles/s41571-023-00754-1

Long-term outcomes following CAR T cell therapy The data demonstrate that CD19-targeted CAR T cells can induce prolonged remissions in patients with B cell malignancies, often with minimal long-term ...

5. kitepharma.com kitepharma.com/news/press-releases/2024/12/longest-follow-up-data-reported-for-kites-tecartus-car-t-cell-therapy-at-ash-2024-reinforce-durable-efficacy-and-survival-benefits

Longest Follow-Up Data Reported for Kite's Tecartus® ... 39% of patients with R/R MCL were still alive after five years, underscoring Tecartus as the only CAR T to have five-year follow-up data in this patient ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06079164

NCT06079164 | Study of KITE-197 in Participants With ... The goal of Phase 1a of this clinical study is to learn more about the safety, tolerability and dosing of study drug KITE-197, in participants with relapsed or ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37890589/

Real-World Outcomes with Chimeric Antigen Receptor T ... Real-World Outcomes with Chimeric Antigen Receptor T Cell Therapies in Large B Cell Lymphoma: A Systematic Review and Meta-Analysis. Transplant Cell Ther.