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CAR T-cell Therapy

JCAR017 for Non-Hodgkin's Lymphoma (TRANSCEND FL Trial)

Phase 2
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients should have received at least one prior therapy that includes anti-CD20 and alkylating agent
Adequate vascular access for leukapheresis procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights

TRANSCEND FL Trial Summary

This trial is testing a new treatment for adult patients with relapsed or refractory (r/r) FL or MZL. The treatment consists of administration of JCAR017 on Day 1, after lymphodepleting (LD) chemotherapy. The study will assess the efficacy and safety of JCAR017 in these patients.

Who is the study for?
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).Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include reactions to the infusion of JCAR017, lowered blood cell counts due to chemotherapy drugs like Cyclophosphamide and Fludarabine, increased risk of infections, fatigue, nausea, as well as possible organ inflammation.

TRANSCEND FL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been treated with a medication targeting CD20 and one that damages DNA.
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I have suitable veins for a blood filtering procedure.
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I am fully active or can carry out light work.
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I have marginal zone lymphoma and have undergone at least two treatments, including anti-CD20 and an alkylating agent, or I've relapsed after a stem cell transplant.

TRANSCEND FL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Adverse Events (AEs)
Complete response rate (CRR) as assessed but PET-CT and/or CT using "The Lugano Classification"
Cognitive Therapy
+8 more

Side effects data

From 2023 Phase 1 & 2 trial • 62 Patients • NCT03310619
100%
Neutropenia
100%
Anaemia
100%
Cytokine release syndrome
100%
Thrombocytopenia
50%
Hypothyroidism
50%
Constipation
50%
Leukopenia
50%
Hypophosphataemia
50%
Hypokalaemia
50%
Sinus tachycardia
50%
Diarrhoea
50%
Cough
50%
Abdominal pain
50%
Syncope
50%
Chills
50%
Hypercalcaemia
50%
Arthralgia
50%
Acute kidney injury
50%
Eye irritation
50%
Dehydration
50%
Neurotoxicity
50%
Contusion
50%
Oropharyngeal pain
50%
Muscular weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)
Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)

TRANSCEND FL Trial Design

1Treatment groups
Experimental Treatment
Group I: Administration of JCAR017Experimental Treatment3 Interventions
Subjects will be treated with fludarabine IV (30 mg/m2/day for 3 days) and cyclophosphamide IV (300 mg/m2/day for 3 days) prior to JCAR017 infusion. Refer to the most recent package inserts for further details on administration of these agents. JCAR017 will be infused on Day 1 at a target dose of 100 × 10^6 CAR-positive viable T cells (CAR+ T cells), 2 to 7 days after completion of LD chemotherapy. Each JCAR017 dose includes CD4+ CAR+ T cells and CD8+ CAR+ T cells.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100
JCAR017
2018
Completed Phase 3
~360

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,758 Total Patients Enrolled
Thalia Farazi, M.D./Ph.DStudy DirectorCelgene Medical Director
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,507 Previous Clinical Trials
3,369,784 Total Patients Enrolled

Media Library

JCAR017 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04245839 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: Administration of JCAR017
Non-Hodgkin's Lymphoma Clinical Trial 2023: JCAR017 Highlights & Side Effects. Trial Name: NCT04245839 — Phase 2
JCAR017 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04245839 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the risk factors associated with JCAR017 treatment?

"Our internal assessment of JCAR017's safety ranked it a 2, owing to the lack of data confirming its efficacy despite existing evidence for safe use."

Answered by AI

How many centers are responsible for administering this research?

"Currently, 33 medical centres are welcoming participants into this clinical trial. Key locations include Chicago, Montreal and Portland in addition to other cities scattered across the country. To reduce travelling obligations associated with participation, it is advised that you select a site nearby your residence."

Answered by AI

Are there any available slots for prospective participants in this medical experiment?

"Affirmative, the information available on clinicaltrials.gov shows that recruitment is ongoing for this medical study, which was originally posted on July 14th 2020 and last updated on October 24th 2022. The trial needs to enroll 213 individuals from 33 different sites."

Answered by AI

What pathology does the drug JCAR017 typically target?

"JCAR017 has been demonstrated to be efficacious for multiple sclerosis, but it can also provide relief in cases of acute lymphoblastic leukemia, myelocytic leukemia, and retinoblastoma. Additionally, some research suggests that JCAR017 is effective against histiocytic lymphomas."

Answered by AI

What is the recruitment capacity of this trial?

"This research necessitates the participation of 213 qualified individuals. Northwestern University in Chicago and Local Institution - 151 in Montreal are among the numerous locations offering this trial to patients."

Answered by AI

Have any other investigations explored the application of JCAR017?

"JCAR017 was first researched in 1997 at the City of Hope Comprehensive Cancer Center. To date, 1275 trials have been completed with 895 still ongoing - notably a large portion of these are conducted out of Chicagoland."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)
2020. "A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04245839.
~115 spots leftby Sep 2028
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