Cema-cel for B-Cell Lymphoma
(ALPHA3 Trial)
Recruiting in Palo Alto (17 mi)
+33 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Allogene Therapeutics
Must not be taking: Anti-CD19 therapies
Disqualifiers: CNS involvement, Autoimmune disease, Infections, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This is a randomized, open-label study in adult patients who have completed standard first line of therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation.
The study is conducted in 2 consecutive parts that will be enrolled continuously. In Part A of the study, participants with MRD are randomized to one of two treatment arms or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide administered with or without the anti-CD52 monoclonal antibody, ALLO-647. Part A will culminate with the selection of the lymphodepletion regimen to advance to Part B. Part B will evaluate the selected lymphodepletion regimen followed by cema-cel as compared with observation.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves a specific treatment regimen, it's best to discuss your current medications with the trial team to ensure there are no conflicts.
What data supports the effectiveness of the treatment Cemacabtagene Ansegedleucel, ALLO-501.1, ALLO-501A, cema-cel for B-Cell Lymphoma?
While there is no direct data on Cemacabtagene Ansegedleucel, similar CAR T-cell therapies like brexucabtagene autoleucel have shown high response rates in treating mantle cell lymphoma, with 91% of patients responding to the treatment. This suggests that CAR T-cell therapies can be effective for certain types of B-cell lymphomas.
12345Eligibility Criteria
This trial is for adults with large B-cell lymphoma (LBCL) who've had a complete or partial response to first-line therapy but still have minimal residual disease (MRD). They must be suitable for observation and have MRD detected by the Foresight CLARITY™ IUO MRD test.Inclusion Criteria
I completed my first round of standard cancer treatment without starting another.
My cancer responded well to the first treatment, as shown by PET/CT scans.
I am 18 years old or older.
I am fully active or restricted in physically strenuous activity but can do light work.
My lymphoma diagnosis matches one of the types listed by WHO 2017.
Exclusion Criteria
I have an active and serious autoimmune disease.
My large B-cell lymphoma has affected my brain or spinal cord, or it has changed from another type of cancer.
I have been treated with anti-CD19 therapies before.
I do not have any active infections needing treatment.
I haven't had another cancer or bone marrow disorder in the last 3 years.
Participant Groups
The study tests cemacabtagene ansegedleucel (cema-cel), a CD19 CAR T cell therapy, after standard chemo drugs fludarabine and cyclophosphamide, with or without ALLO-647. It compares this treatment's effectiveness and safety against just observing patients.
3Treatment groups
Experimental Treatment
Group I: cemacabtagene ansegedleucel, ALLO-647Experimental Treatment5 Interventions
Participants receive cemacabtagene ansegedleucel following lymphodepletion regimen comprised of fludarabine, cyclophosphamide, and ALLO-647.
Group II: cemacabtagene ansegedleucelExperimental Treatment4 Interventions
Participants receive cemacabtagene ansegedleucel following lymphodepletion regimen comprised of fludarabine and cyclophosphamide.
Group III: ObservationExperimental Treatment1 Intervention
Participants do not receive any study treatments. They are observed as per the current standard of care.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Oncology Hematology Care - KenwoodCincinnati, OH
Virginia Cancer SpecialistsFairfax, VA
Rocky Mountain Cancer CentersDenver, CO
Alta Bates Summit Medical CenterBerkeley, CA
More Trial Locations
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Who is running the clinical trial?
Allogene TherapeuticsLead Sponsor
Foresight Diagnostics, Inc.Collaborator
References
Brexucabtagene Autoleucel for Relapsed or Refractory Mantle Cell Lymphoma in Standard-of-Care Practice: Results From the US Lymphoma CAR T Consortium. [2023]Brexucabtagene autoleucel (brexu-cel) is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory mantle cell lymphoma (MCL). This therapy was approved on the basis of the single-arm phase II ZUMA-2 trial, which showed best overall and complete response rates of 91% and 68%, respectively. We report clinical outcomes with brexu-cel in the standard-of-care setting for the approved indication.
Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma. [2023]Ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen (BCMA)-directed CAR T-cell therapy, is effective in heavily pretreated patients with relapsed or refractory multiple myeloma. We investigated cilta-cel in earlier treatment lines in patients with lenalidomide-refractory disease.
Brexucabtagene Autoleucel: A Novel Chimeric Antigen Receptor T-cell Therapy for the Treatment of Mantle Cell Lymphoma. [2022]To identify and assess the current literature surrounding the safety, efficacy, and practical considerations of brexucabtagene autoleucel (brexu-cel) for the treatment of relapsed or refractory (r/r) mantle cell lymphoma (MCL).
Axicabtagene Ciloleucel in the Non-Trial Setting: Outcomes and Correlates of Response, Resistance, and Toxicity. [2022]Axicabtagene ciloleucel (axi-cel) was approved by the Food and Drug Administration for relapsed aggressive B-cell non-Hodgkin lymphoma in part on the basis of durable remission rates of approximately 40% in a clinical trial population. Whether this efficacy, and the rates of toxicity, would be consistent in a postcommercial setting, with relaxed eligibility criteria and bridging therapy, is unknown. This study describes the efficacy and safety correlates and outcomes in this setting.
Component Costs of CAR-T Therapy in Addition to Treatment Acquisition Costs in Patients with Multiple Myeloma. [2023]Label="INTRODUCTION" NlmCategory="BACKGROUND">Ciltacabtagene autoleucel (cilta-cel), is a B-cell maturation antigen-directed, genetically modified autologous chimeric antigen receptor T-cell (CAR-T) immunotherapy. It is indicated for treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The objective of this study was to estimate the per-patient US commercial healthcare costs related to cilta-cel (CARVYKTI®) CAR-T therapy (i.e., costs separate from cilta-cel therapy acquisition) for patients with RRMM.
Long-term outcomes of relmacabtagene autoleucel in Chinese patients with relapsed/refractory large B-cell lymphoma: Updated results of the RELIANCE study. [2023]The RELIANCE study has demonstrated the activity and safety of relmacabtagene autoleucel (relma-cel) (JW Therapeutics [Shanghai] Co, Ltd, Shanghai, China), a CD19-targeted chimeric antigen receptor T-cell product, in patients with heavily pre-treated relapsed/refractory large B-cell lymphoma (r/r LBCL). This study aimed to report the updated 2-year data of the RELIANCE study.
Axicabtagene Ciloleucel: Clinical Data for the Use of CAR T-cell Therapy in Relapsed and Refractory Large B-cell Lymphoma. [2021]To evaluate the literature for axicabtagene ciloleucel (axi-cel), a first-in-class chimeric antigen receptor (CAR) T-cell therapy, in the treatment of relapsed/refractory (r/r) large B-cell lymphoma (LBCL).