JCAR017 for Non-Hodgkin's Lymphoma

(TRANSCEND FL Trial)

Not currently recruiting at 142 trial locations
Rs
Fl
BS
Overseen ByBMS Study Connect Contact Center www.BMSStudyConnect.com
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Celgene
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called JCAR017 (a type of CAR T-cell therapy) for individuals with certain types of non-Hodgkin's lymphoma, specifically follicular lymphoma (FL) and marginal zone lymphoma (MZL), that have not responded well to previous treatments. The goal is to assess the effectiveness and safety of JCAR017 for these conditions. Participants will first receive chemotherapy to prepare their bodies, followed by an infusion of JCAR017. This trial may suit those recently diagnosed with FL or MZL who have tried other treatments, including anti-CD20 and alkylating agents, but still experience their lymphoma. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the treatment involves chemotherapy and cell therapy, it's possible that some medications might need to be adjusted. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that JCAR017 is likely to be safe for humans?

Research has shown that JCAR017, also known as lisocabtagene maraleucel or liso-cel, holds promise for safety in treating certain types of non-Hodgkin's lymphoma. Earlier studies revealed that most patients tolerated this treatment well. For instance, many patients with marginal zone lymphoma (MZL) responded positively, indicating the treatment's effectiveness and manageability for many individuals.

Additionally, the FDA has already approved liso-cel for other types of non-Hodgkin's lymphoma, supporting its safety profile. While some side effects may occur, as with any treatment, evidence suggests these are generally manageable. Overall, the findings provide a reassuring picture of its use in treating lymphoma.12345

Why do researchers think this study treatment might be promising?

JCAR017 is unique because it uses a cutting-edge approach called CAR T-cell therapy, which reprograms a patient's own immune cells to specifically target and destroy cancer cells in Non-Hodgkin’s Lymphoma. Unlike conventional treatments such as chemotherapy and radiation, which can affect both healthy and cancerous cells, JCAR017 provides a more targeted attack, minimizing damage to normal cells. This precision in targeting cancer cells is what excites researchers, as it holds the promise of being more effective with potentially fewer side effects compared to existing therapies.

What evidence suggests that JCAR017 might be an effective treatment for Non-Hodgkin's Lymphoma?

Research shows that JCAR017, also known as lisocabtagene maraleucel, holds promise for treating non-Hodgkin's lymphoma, particularly when other treatments have failed. Studies found that 95.5% of patients with relapsed or hard-to-treat marginal zone lymphoma (MZL) responded well to this treatment. This is significant because traditional treatments often result in less than 7% of patients fully responding when chemotherapy fails. In this trial, participants will receive JCAR017 after a preparatory regimen of fludarabine and cyclophosphamide. The treatment involves infusing specially modified immune cells to target and destroy cancer cells. Early evidence suggests these positive responses can be strong and long-lasting, offering new hope for patients with challenging types of lymphoma.15678

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for adults with relapsed or refractory indolent B-cell Non-Hodgkin Lymphoma who've had at least one prior therapy including anti-CD20 and an alkylating agent. They should have good organ function, no central nervous system-only cancer, no history of CAR T-cell therapy, and be in fairly good health (ECOG 0 or 1).

Inclusion Criteria

I have been treated with a medication targeting CD20 and one that damages DNA.
I have follicular lymphoma and have been treated with at least one systemic therapy including anti-CD20 and an alkylating agent.
I have suitable veins for a blood filtering procedure.
See 4 more

Exclusion Criteria

I have active hepatitis B or C.
I had a stem cell transplant from a donor within the last 3 months.
I have received CAR T-cell or similar genetic therapy before.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pretreatment

Screening assessments, leukapheresis, and Pretreatment evaluation

2-4 weeks

Treatment

Administration of lymphodepleting chemotherapy followed by JCAR017 infusion

4 weeks
Multiple visits for chemotherapy and infusion

Posttreatment

Follow-up assessments for disease status and safety

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cyclophosphamide
  • Fludarabine
  • JCAR017
Trial Overview The study tests JCAR017's effectiveness and safety after a lymphodepleting chemotherapy regimen with Cyclophosphamide and Fludarabine. It's a global Phase 2 trial where patients are monitored from treatment through five years post-treatment.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Administration of JCAR017Experimental Treatment3 Interventions

JCAR017 is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Breyanzi for:
🇪🇺
Approved in European Union as Breyanzi for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Celgene

Lead Sponsor

Trials
649
Recruited
130,000+
Top Products
>- **Revlimid (lenalidomide)**: Multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma treatment. - **Pomalyst (pomalidomide)**: Relapsed/refractory multiple myeloma treatment. - **Otezla (apremilast)**: Psoriatic arthritis treatment. - **Thalomid (thalidomide)**: Erythema nodosum leprosum and multiple myeloma treatment.
Jay Backstrom profile image

Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles profile image

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Published Research Related to This Trial

In a phase 2 trial involving 61 patients with relapsed or refractory large B-cell lymphoma, lisocabtagene maraleucel demonstrated a high overall response rate of 80%, indicating its efficacy as a second-line treatment for patients not intended for stem-cell transplantation.
The treatment was generally safe, with no treatment-related deaths reported; however, common serious side effects included neutropenia and cytokine release syndrome, which occurred in 38% of patients, highlighting the need for monitoring during treatment.
Lisocabtagene maraleucel as second-line therapy in adults with relapsed or refractory large B-cell lymphoma who were not intended for haematopoietic stem cell transplantation (PILOT): an open-label, phase 2 study.Sehgal, A., Hoda, D., Riedell, PA., et al.[2022]
Lisocabtagene Maraleucel (Liso-cel) is a promising CAR-T therapy targeting CD19, showing strong antitumor activity in aggressive B-cell lymphomas with manageable toxicity, as confirmed in the TRANSCEND NHL001 trial.
Preclinical studies indicate that a specific ratio of CD4+ and CD8+ T-cells enhances the effectiveness of Liso-cel, suggesting a well-balanced approach to maximizing both efficacy and safety in treatment.
Lisocabtagene Maraleucel for the treatment of B-cell lymphoma.Iragavarapu, C., Hildebrandt, G.[2022]
Lisocabtagene maraleucel (liso-cel) is an effective CAR T cell therapy for relapsed or refractory large B cell lymphoma, showing a 73% objective response rate and a 53% complete remission rate in a study of 344 patients.
The treatment demonstrated a 12-month overall survival rate of 58% for all patients and 86% for those who achieved complete remission, although it was associated with adverse events such as cytokine release syndrome (42%) and neurological issues (30%).
Lisocabtagene Maraleucel in Relapsed or Refractory Diffuse Large B Cell Lymphoma: What is the Evidence?Kharfan-Dabaja, MA., Yassine, F., Moustafa, MA., et al.[2023]

Citations

NCT02631044 | Study Evaluating the Safety and ...We will also determine how long the modified T cells stay in the patient's body and how well JCAR017 works in treating patients with non-Hodgkin's lymphoma ...
Corporate news details95.5% of patients with relapsed or refractory marginal zone lymphoma (MZL) treated with lisocabtagene maraleucel (liso-cel) achieved a response.
Clinical Review - Lisocabtagene Maraleucel (Breyanzi) - NCBIOutcomes are worse in patients with chemotherapy-refractory disease, with only 7% achieving a complete response (CR) to standard treatment and overall survival ...
Lisocabtagene Maraleucel Versus Standard of Care for ...Results are reported descriptively. With a median follow-up of 33.9 months, median (95% CI) event-free survival was 29.5 months (9.5 to not ...
Two-year follow-up of lisocabtagene maraleucel in relapsed ...Outcomes have been particularly poor for patients with chemotherapy-refractory disease, with CR rates of ∼7% to conventional therapy and an ...
6.breyanzi.combreyanzi.com/
Home | Breyanzi® (lisocabtagene maraleucel) CAR T Cell ...BREYANZI is a prescription medicine used to treat 4 types of non-Hodgkin lymphoma: Large B cell lymphoma, when: your first treatment has not worked or your ...
Press Release - Investors - Bristol Myers Squibb95.5% of patients with relapsed or refractory marginal zone lymphoma (MZL) treated with lisocabtagene maraleucel (liso-cel) achieved a response.
Lisocabtagene maraleucel for R/R LBCL in patients not ...The safety and efficacy of lisocabtagene maraleucel (liso-cel), an autologous, CD19-directed, 4-1BB CAR T-cell product, is well established ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security