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CAR T-cell Therapy

JCAR017 for Non-Hodgkin's Lymphoma (PLATFORM Trial)

Phase 1 & 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1, 3, 6, 9, 12, 18 and 24 months post-jcar017 infusion
Awards & highlights

PLATFORM Trial Summary

This trial is testing JCAR017, a CAR T cell therapy, in combination with other agents to treat various cancers. The study will assess the safety, tolerability, efficacy, and patient-reported quality of life of JCAR017 in combination with different agents. The study will be conducted in two parts: a dose-finding phase and a dose-expansion phase.

Eligible Conditions
  • Lymphoma
  • Non-Hodgkin's Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma

PLATFORM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1, 3, 6, 9, 12, 18 and 24 months post-jcar017 infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1, 3, 6, 9, 12, 18 and 24 months post-jcar017 infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response Rate (CRR)
Number of Participants With Dose-Limiting Toxicity (DLT)
Secondary outcome measures
Change From Baseline Erythrocyte Numbers
Change From Baseline Hematocrit Ratio
Change From Baseline in Coagulation Times
+22 more

Side effects data

From 2023 Phase 1 & 2 trial • 62 Patients • NCT03310619
100%
Neutropenia
100%
Anaemia
100%
Thrombocytopenia
100%
Cytokine release syndrome
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)

PLATFORM Trial Design

6Treatment groups
Experimental Treatment
Group I: Arm F: JCAR017 in combination with CC-99282Experimental Treatment2 Interventions
This arm will test JCAR017 in combination with CC-99282 in adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10^6 CAR+T cells. The combination agent will be administered at different doses and/or schedules.
Group II: Arm E: JCAR017 in combination with relatlimab and/or nivolumabExperimental Treatment3 Interventions
This arm will test JCAR017 in combination with relatlimab and/or nivolumab in adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10^6 CAR+T cells. The combination agent will be administered at different doses and/or schedules
Group III: Arm D: JCAR017 in combination with IbrutinibExperimental Treatment2 Interventions
This arm will test JCAR017 in combination with ibrutinib. In adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10^6 CAR+T cells. The combination agent will be administered at a fixed dose of 420 mg daily
Group IV: Arm C: JCAR017 in combination with CC-220Experimental Treatment2 Interventions
This arm will test JCAR017 in combination with CC-220. In adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10^6 CAR+T cells. The combination agent will be administered at different doses
Group V: Arm B: JCAR017 in combination with CC-122Experimental Treatment2 Interventions
This arm will test JCAR017 in combination with the CC-122. In adult subjects with R/R aggressive B-cell NHL. JCAR017 will be administered at a dose of 100 x 10^6 CAR+T cells. The combination agent will be administered at different doses
Group VI: Arm A: JCAR017 in combination with DurvalumabExperimental Treatment2 Interventions
JCAR017 will be administered at a single flat dose of 50 x 10^6 CAR+T cells or 100 x 10^6 CAR+T cells. The combination agent will be administered at different doses and/ or schedules
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CC-99282
2017
Completed Phase 2
~70
Nivolumab
2014
Completed Phase 3
~4750
CC-220
2016
Completed Phase 2
~620
JCAR017
2018
Completed Phase 3
~360
Durvalumab
2017
Completed Phase 2
~3870
Ibrutinib
2014
Completed Phase 3
~1880
CC-122
2015
Completed Phase 2
~670
Relatlimab
2018
Completed Phase 2
~1120

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,893 Total Patients Enrolled
Ronald Dubowy, MDStudy DirectorCelgene
1 Previous Clinical Trials
169 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,507 Previous Clinical Trials
3,369,919 Total Patients Enrolled

Frequently Asked Questions

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

Are there any historical investigations of the efficacy of JCAR017?

"As of 2010, City of Hope was the first to study JCAR017 and has since completed 458 trials. Nowadays, there are 1,209 active studies taking place in areas such as Houston, Texas."

Answered by AI

How many participants are being monitored in this clinical trial?

"This trial has since concluded its recruitment drive, having been first posted on November 28th 2017 and last edited on September 30th 2022. However, 4013 trials for lymphoma follicular are still recruiting patients as well as 1209 studies for JCAR017."

Answered by AI

What conditions has JCAR017 been clinically demonstrated to ameliorate?

"Unresectable melanoma is often treated with JCAR017, although this medication has also been successful at fighting squamous cell carcinoma, high risk of recurrence, and other diseases."

Answered by AI

Is there a call for participants in this scientific inquiry?

"This trial is no longer actively seeking participants. The protocol was initially announced on November 28th 2017 and the last edit took place on September 30th 2022. If you are searching for similar trials, there are currently 4013 with lymphoma/follicular patients and 1209 open studies examining JCAR017's efficacy."

Answered by AI

Are there any Canadian healthcare facilities in which this clinical trial is taking place?

"This medical experiment is being conducted across 24 different clinics in the USA, including Houston, Philadelphia and Boston. It's recommended to join the nearest facility to reduce travel requirements if you sign up for this trial."

Answered by AI

What are the aims of this medical experiment?

"The primary endpoint of this clinical trial, measured over the duration between first administration of combination agent and 28 days after JCAR017 infusion or from JCAR017 infusion until one month post-combination drug dose is Complete Response Rate. Secondary objectives include Event-free Survival (EFS), European Quality of Life - 5 Dimensions health state classifier to five levels (EQ-5D-5L) and Health Related Quality Of Life (HRQoL)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed/Refractory B-cell Malignancies
2017. "A Safety and Efficacy Trial of JCAR017 Combinations in Subjects With Relapsed/Refractory B-cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03310619.
~8 spots leftby Apr 2025
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