BEAM-201 for T-cell Leukemia/Lymphoma
Recruiting in Palo Alto (17 mi)
+10 other locations
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: Beam Therapeutics Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?This is a Phase 1/2, multicenter, open-label study to evaluate the safety and efficacy of BEAM-201 in patients with relapsed/refractory T-ALL or T-LL. This study consists of Phase 1 dose-exploration cohorts, Phase 1 dose-expansion cohort(s), a Phase 1 pediatric cohort (will enroll patients ages 1 to \< 12 years), and a Phase 2 cohort.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot have received systemic antileukemic therapy intended to induce or maintain remission within 14 days before completing screening.
What data supports the idea that BEAM-201 for T-cell Leukemia/Lymphoma (also known as: BEAM-201, BEAM-201) is an effective treatment?
The available research does not provide specific data on BEAM-201 for T-cell Leukemia/Lymphoma. Instead, it discusses total skin electron beam therapy (TSEB) for a related condition, mycosis fungoides, which is a type of T-cell lymphoma. In one case, a patient with advanced-stage mycosis fungoides showed a nearly complete response to low-dose TSEB, remaining in remission for over four years. However, this information does not directly support the effectiveness of BEAM-201 for T-cell Leukemia/Lymphoma.
12345What safety data is available for BEAM-201 treatment in T-cell Leukemia/Lymphoma?
The provided research does not contain specific safety data for BEAM-201 treatment in T-cell Leukemia/Lymphoma. The articles focus on CAR-T cell therapies for B-cell malignancies, such as diffuse large B-cell lymphoma and acute lymphoblastic leukemia, and discuss adverse events like cytokine release syndrome and neurological toxicity. However, these findings may not directly apply to BEAM-201 or T-cell Leukemia/Lymphoma.
678910Eligibility Criteria
This trial is for people aged 1 to 50 with T-Cell Acute Lymphoblastic Leukemia or T-Cell Lymphoblastic Lymphoma that has come back or didn't respond to treatment. They should have a certain amount of cancer cells in their bone marrow or evidence of the disease after a second remission, and be eligible for a type of stem cell transplant.Inclusion Criteria
I am approved for a stem cell transplant and have a donor.
My T-ALL/T-LL cancer is in its second or later relapse, has come back after a transplant, or hasn't responded to chemotherapy.
I am between 1 and 17 years old.
+1 more
Exclusion Criteria
I have previously received CD7 targeted therapy.
I have received treatment for leukemia within the last 14 days.
I have brain-related symptoms or permanent nerve damage from past leukemia treatments.
+1 more
Participant Groups
The study tests BEAM-201's safety and effectiveness on patients with relapsed/refractory T-ALL/T-LL. It includes initial dose-finding, expansion cohorts, a pediatric group (ages 1 to <12), and Phase 2 cohort to determine how well it works at selected doses.
2Treatment groups
Experimental Treatment
Group I: Fludarabine, cyclophosphamide without alemtuzumabExperimental Treatment1 Intervention
Lymphodepletion regimen without Alz but consisting of the same dose of Flu/Cy as in the other arm
Group II: Fludarabine, cyclophosphamide and alemtuzumabExperimental Treatment1 Intervention
Lymphodepletion regimen including fludarabine, cyclophosphamide and alemtuzumab
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Colorado Blood Cancer InstituteDenver, CO
University of ChicagoChicago, IL
Methodist Hospital - Texas Transplant InstituteSan Antonio, TX
Dana Farber and Boston Children's HospitalBoston, MA
More Trial Locations
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Who Is Running the Clinical Trial?
Beam Therapeutics Inc.Lead Sponsor
References
Rapidly progressive stage IVB mycosis fungoides treated with low-dose total skin electron beam therapy. [2022]Mycosis fungoides (MF) is the most common subtype of primary cutaneous T-cell lymphoma. Normally, MF has an indolent course although patients can progress to an advanced disease state (stages IIB-IVB). Advanced-stage disease is typically aggressive, leaving patients with debilitating symptoms and a decreased quality of life. Moreover, advanced-stage MF often proves refractory to therapy and carries a very poor prognosis. Total skin electron beam (TSEB) therapy is a well-established and successful treatment for early stage MF; however, its efficacy dramatically decreases with advanced-stage disease. In fact, TSEB in advanced-stage MF is generally considered to be palliative. Current consensus guidelines recommend a dose of 30-36 Gy to be delivered in 8-10 weeks; however, limited studies exist to determine the ideal treatment in Stage IV MF. Herein, we describe a case of a 50-year-old male who developed rapidly progressive stage IVB (T3N3M1B0) MF and was treated with low-dose (24 Gy) TSEB over 8 weeks. The patient was not treated with any systemic therapy before starting TSEB due to the widespread nature and the speed of disease progression. Remarkably, our patient showed nearly complete (95%) response of his MF with no apparent side effects from radiation. Furthermore, he has remained in remission over 4 years, requiring only a small boost to a few "shadowed" areas. Our case illustrates the benefit of using TSEB in stage IV MF. Additionally, our experience shows that low-dose TSEB can occasionally be efficacious in stage IV disease.
Systemic chemotherapy and extracorporeal photochemotherapy for T3 and T4 cutaneous T-cell lymphoma patients who have achieved a complete response to total skin electron beam therapy. [2019]To evaluate the impact of systemic adjuvant therapies on relapse-free (RFS) and overall survival (OS) of cutaneous T-cell lymphoma (CTCL) patients treated with total skin electron beam therapy (TSEBT).
Prognosis with newly diagnosed mycosis fungoides after total skin electron radiation of 30 or 35 GY. [2019]To determine the prognosis of new patients with T1-4N0-1B0M0 mycosis fungoides treated with total skin electron beam radiation.
Total skin electron beam therapy for primary cutaneous T-cell lymphomas: clinical characteristics and outcomes in a Mexican reference center. [2022]The aim of this study was to assess treatment modalities, treatment response, toxicity profile, disease progression and outcomes in 14 patients with a confirmed diagnosis of primary cutaneous T-cell lymphoma (PCTCL) treated with total skin electron beam therapy (TSEBT).
[Total skin electron beam therapy for early-stage mycosis fungoides: immediate results and long-term follow-up in 68 patients]. [2009]Our aim was to evaluate the efficacy of total skin electron beam therapy (TSEB) in the management of early-stage mycosis fungoides in order to assess its position in relation to other skin-directed therapies.
CAR-T Cell Therapy in Diffuse Large B Cell Lymphoma: Hype and Hope. [2020]Patients with non-Hodgkin lymphomas (NHLs) resistant to standard therapies have a dismal prognosis. The outcome is even poorer in patients relapsing after autologous stem cell transplantation. Most of these patients do not qualify for an allogeneic hematopoietic cell transplantation (HCT) due to refractory disease, lack of a suitable allogeneic donor, higher age, or cumulative toxicity of previous chemotherapy. Despite patients undergoing allogeneic HCT normally profit from a graft-versus-lymphoma effect, overall survival in patients with NHL after HCT remains short. Therefore, novel treatment modalities are urgently needed. Chimeric antigen receptor (CAR)-T cells, a new class of cellular immunotherapy involving ex vivo genetic modification of T cells to incorporate an engineered CAR have been used in clinical trials. In the majority of studies, B cell malignancies treated with CD19 targeting CAR-T cells have been analyzed. Recently, results from 2 CD19 directed CAR-T cell trials with an increased follow-up of patients led to Food and Drug Administration and European Medicines Agency approval of tisagenlecleucel and axicabtagene ciloleucel. Common adverse events (AEs) include cytokine release syndrome and neurological toxicity, which may require admission to an intensive care unit, B cell aplasia and hemophagocytic lymphohistiocytosis. These AEs are manageable when treated by an appropriately trained team following established algorithm. In this review, we summarize the results of 3 large phase II CD19 CAR-T cell trials and focus on AEs. We also provide a perspective of ongoing activity in this field with the intend to improve the potency of this emerging novel therapy.
Management of adverse effects of new monoclonal antibody treatments in acute lymphoblastic leukemia. [2020]Therapeutic options for relapsed/refractory B-cell acute lymphoblastic leukemia have evolved in the past few years. The FDA has approved three novel therapies for this disease: inotuzumab ozogamicin (an anti-CD22 antibody-drug conjugate), blinatumomab (a bispecific T-cell engager), and chimeric antigen receptor T-cell therapy. Although these novel immunotherapies have revolutionized the therapeutic landscape, it is important to understand the crucial aspects of administration, especially toxicity. In this article, we review the unique toxicities and adverse effects of blinatumomab and inotuzumab ozogamicin and provide recommendations for prevention of adverse effects as well as the management options for each medication.
The potential of CAR T therapy for relapsed or refractory pediatric and young adult B-cell ALL. [2020]Recent advancements in immunooncology have resulted in the generation of novel therapies such as chimeric antigen receptor (CAR) T cells, which have revolutionized the treatment of pediatric patients with relapsed or refractory B-cell acute lymphoblastic leukemia. The journey of tisagenlecleucel (formerly CTL019) from early preclinical success to the US Food and Drug Administration approval is summarized in this review. Strategies that are currently being investigated to improve the efficacy and safety profile of CAR T-cells are also explored, as well as the factors contributing to the present state of patient access to CAR T therapy.
Approval of brexucabtagene autoleucel for adults with relapsed and refractory acute lymphocytic leukemia. [2022]In October 2021, brexucabtagene autoleucel became the first anti-CD19 chimeric antigen receptor T-cell product to receive approval from the Food and Drug Administration to treat adults with relapsed and refractory B-cell acute lymphoblastic leukemia. The approval is based on results from the Zuma-3 trial and significantly widens treatment options for this patient population. In this article, we review outcomes from this study and its implications.
Exposure-adjusted adverse events comparing blinatumomab with chemotherapy in advanced acute lymphoblastic leukemia. [2020]In the phase 3 TOWER study, blinatumomab demonstrated an overall survival benefit over standard-of-care chemotherapy (SOC) in adults with relapsed or refractory (r/r) Philadelphia chromosome-negative (Ph-) B-precursor acute lymphoblastic leukemia (ALL). Nearly all patients in both treatment arms experienced an adverse event (AE), and the incidence rate of serious AEs was higher for blinatumomab. However, as treatment exposure differed between the 2 arms, we conducted an exploratory safety analysis comparing exposure-adjusted event rates (EAERs) of blinatumomab vs SOC. Analyses were conducted for all patients who received therapy (safety population). Patients received a median (range) of 2 cycles (1-9) of blinatumomab (N = 267) vs 1 cycle (1-4) of SOC (N = 109). Grade ≥3 AE rates were generally higher in cycle 1 of blinatumomab than in cycle 2 (76% vs 37%). After adjusting for time on treatment, EAERs of grade ≥3 were significantly lower for blinatumomab vs SOC overall (10.73 vs 45.27 events per patient-year; P < .001) and for events of clinical interest, including infections (1.63 vs 6.49 events per patient-year; P < .001), cytopenias (3.64 vs 20.07 events per patient-year; P < .001), and neurologic events (0.38 vs 0.95 events per patient-year; P = .008). The EAER of grade ≥3 cytokine-release syndrome was higher for blinatumomab than for SOC (0.16 vs 0 events per patient-year; P = .038). These data further support the role of blinatumomab as an efficacious and well-tolerated treatment option for patients with r/r Ph- ALL. This trial was registered at www.clinicaltrials.gov as #NCT02013167.
Newer developments in adult T-cell leukemia/lymphoma therapeutics. [2013]Adult T-cell leukemia/lymphoma (ATL) is a rare disease with a unique geographic distribution. Conducting controlled randomized trials to assess the effective therapeutic strategies has therefore been a significant challenge to date.
Nelarabine, intensive L-asparaginase, and protracted intrathecal therapy for newly diagnosed T-cell acute lymphoblastic leukaemia in children and young adults (ALL-T11): a nationwide, multicenter, phase 2 trial including randomisation in the very high-risk group. [2023]T-cell acute lymphoblastic leukaemia has distinct biological characteristics and a poorer prognosis than B-cell precursor acute lymphoblastic leukaemia. This trial aimed to reduce the rate of radiation and haematopoietic stem-cell transplantation (HSCT) while improving outcomes by adding nelarabine, intensified L-asparaginase, and protracted intrathecal therapy in the Berlin-Frankfurt-Münster (BFM)-type treatment.