KITE-197 for Large B-cell Lymphoma
Recruiting in Palo Alto (17 mi)
+11 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Kite, A Gilead Company
Must not be taking: CD19 antibodies, Bendamustine, CAR therapy
Disqualifiers: Other malignancy, Richter's transformation, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a new drug called KITE-197 for patients whose large B-cell lymphoma has returned or didn't respond to previous treatments. The study will first check if the drug is safe and find the best dose. Then, it will see if this dose can help eliminate the cancer completely. Another treatment for this type of lymphoma is available for those who have not responded to multiple previous treatments.
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.
What data supports the effectiveness of the drug KITE-197 for treating large B-cell lymphoma?
The research suggests that while current treatments for aggressive lymphomas like large B-cell lymphoma have limited long-term success, new approaches such as CAR T-cells, which are similar to KITE-197, show promise in treating relapsed cases due to their unique way of targeting cancer cells.
12345Eligibility Criteria
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.
It looks like there might be a mistake or missing information in your request. Could you please provide more details or clarify the criterion you'd like to have rewritten in simpler language?
You have at least one lesion that can be measured.
+1 more
Trial Timeline
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.
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: KITE-197Experimental Treatment3 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Sylvester Comprehensive Cancer CenterMiami, FL
St. David's South Austin Medical CenterAustin, TX
University of Chicago Medical CenterChicago, IL
Jewish General HospitalMontréal, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
Kite, A Gilead CompanyLead Sponsor
References
Current strategies for the treatment of diffuse large B cell lymphoma. [2019]This paper reviews the improvement in the treatment of patients with diffuse large B cell lymphoma.
Current treatment options in aggressive lymphoma. [2019]The overall percentage of patients achieving long-term remissions in aggressive non-Hodgkin's lymphoma (NHL) using CHOP or CHOP-based primary chemotherapy is only 40%. Much effort has therefore been concentrated on developing strategies to improve this figure. More intensive variants of CHOP chemotherapy, such as multi-agent "third-generation" regimens, have failed to improve long-term survival, and are also associated with increased toxicity. Hence, there is a need for improved treatment regimens, both as primary therapy and for patients in first and subsequent relapse. This need is most acute in elderly patients (> 60 years of age), who comprise more than 50% of NHL cases and who may not be able to tolerate subsequent intensive chemotherapy at relapse. Approaches currently being examined to improve outcome include: the use of clinical, histological and molecular prognostic factors to establish a patient's risk group, and so define those patients most likely to benefit from early aggressive therapy; the inclusion of high-dose therapy and autologous transplantation; and the integration of novel therapies, such as immunotherapy and radioimmunotherapy, into existing treatment strategies. The impact of these approaches on the treatment of diffuse, large B-cell lymphoma and mantle cell lymphoma is discussed below.
ACCELERATE and European Medicine Agency Paediatric Strategy Forum for medicinal product development for mature B-cell malignancies in children. [2020]Paediatric Strategy Forums have been created by the multistakeholder organisation, ACCELERATE, and the European Medicines Agency to facilitate dialogue between all relevant stakeholders and suggest strategies in critical areas of paediatric oncology drug development. As there are many medicines being developed for B-cell malignancies in adults but comparatively few in children with these malignancies, a Paediatric Strategy Forum was held to discuss the best approach to develop these products for children. It was concluded that as current frontline therapy is highly successful, despite associated acute toxicity, de-escalation of this or substitution of presently used drugs with new medicines can only be undertaken when there is an effective salvage regimen, which is currently not available. Therefore priority should be given to developing treatment for patients with relapsed and refractory mature B-cell lymphomas. The consensus of the clinicians attending the meeting was that CAR T-cells, T-cell engagers and antibody drug conjugates (excluding those with a vinca alkaloid-like drug) presently have the greatest probability of providing benefit in relapse in view of their mechanism of action. However, as producing autologous CAR T-cells currently takes at least 4 weeks, they are not products which could be quickly employed initially at relapse in rapidly progressing mature B-cell malignancies but only for the consolidation phase of the treatment. Global, industry-supported, academic-sponsored studies testing compounds from different pharmaceutical companies simultaneously should be considered in rare populations, and it was proposed that an international working group be formed to develop an overarching clinical trials strategy for these disease groups. Future Forums are planned for other relevant paediatric oncologic diseases with a high unmet medical need and relevant molecular targets.
A multicenter phase II study incorporating high-dose rituximab and liposomal doxorubicin into the CODOX-M/IVAC regimen for untreated Burkitt's lymphoma. [2022]Despite improvement with intensive multi-agent chemotherapy, 2-year progression-free survival (PFS) rates for adults with high-risk Burkitt's lymphoma (BL) remains
[Chemotherapy for B lymphoid malignancy in childhood--results in BLK88 protocol]. [2015]Ten cases of newly diagnosed pediatric B cell non-Hodgkin's lymphoma or acute lymphoblastic leukemia (B-NHL, stage I & II 6 cases, stage III & IV 2 cases/ALL 2 cases) experienced during the last 7 years (1987-1994) were treated by BLK88 protocol, which consisted of HD-CPM (1,200 mg/m2), and HD-MTX (1,000 mg/m2) with VCR, ADR, and/or AraC combination, and CNS prophylaxis by triple intrathecal injection. The therapy duration was 24 weeks for B-NHL (36 weeks for B-ALL). The results showed that while one of the six cases in stage I & II relapsed, and other 4 cases of stage III & IV B-NHL/ALL remained in complete remission. On the other hand, all of the four cases in stage III & IV in historical controls had relapsed. Neutropenia and liver dysfunction were observed during therapy, but they were tolerable. We conclude that BLK88 is a very useful protocol for B-NHL/ALL in childhood.