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CAR T-cell Therapy

JCARH125 for Multiple Myeloma (EVOLVE Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Juno Therapeutics, a Subsidiary of 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 2 years
Awards & highlights

EVOLVE Trial Summary

This trial is testing a new cancer treatment for people with multiple myeloma who haven't responded to other treatments. The treatment will be given to see if it is safe and effective.

Eligible Conditions
  • Multiple Myeloma

EVOLVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1 Anakinra Cohort only: Incidence and severity of Grade 2 or higher cytokine release syndrome (CRS)
Phase 1 Anakinra Cohort only: Percentage of subjects with no CRS on Days 1, 2, or 3 following JCARH125 infusion
Anakinra
+4 more
Secondary outcome measures
Phase 1 and Phase 2: Area under the concentration vs time curve (AUC) of JCARH125 in the blood
Phase 1 and Phase 2: Complete response (CR) rate
Phase 1 and Phase 2: Duration of persistence of JCARH125 CAR T cells in the blood
+14 more

Side effects data

From 2018 Phase 2 & 3 trial • 104 Patients • NCT01809132
19%
Acute Kidney Injury
11%
Ascites
9%
Nausea
9%
Urinary tract infection
8%
Hematemesis
8%
Upper GI hemorrhage
8%
Clostridium difficile infection
6%
Hepatic failure
6%
Encephalopathy
6%
C. difficile infection
4%
Respiratory Failure
4%
Peritonitis
4%
Esophageal varices hemorrhage
4%
Tachycardia
4%
Multiple Organ Dysfunction Syndrome (MODS)
2%
Viremia
2%
Baceteremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anakinra & Pentoxifylline & Zinc Sulfate
Methylprednisolone
Observational

EVOLVE Trial Design

2Treatment groups
Experimental Treatment
Group I: JCARH125 + anakinraExperimental Treatment1 Intervention
Subjects will receive a course of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by prophylactic treatment with anakinra and a single dose of JCARH125
Group II: JCARH125Experimental Treatment1 Intervention
Subjects will receive a course of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by a single dose of JCARH125
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JCARH125
2018
Completed Phase 2
~170
JCARH125 + anakinra
2018
Completed Phase 2
~170

Find a Location

Who is running the clinical trial?

Juno Therapeutics, a Subsidiary of CelgeneLead Sponsor
11 Previous Clinical Trials
1,285 Total Patients Enrolled
3 Trials studying Multiple Myeloma
334 Patients Enrolled for Multiple Myeloma
Ronald Dubowy, MDStudy DirectorBristol-Myers Squibb
1 Previous Clinical Trials
62 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 open spots left in this clinical experiment?

"According to the clinicaltrials.gov database, this trial has stopped recruitment as of November 4th 2022. Despite its closure, there are still 840 other trials actively looking for participants."

Answered by AI

To what diseases or conditions has JCARH125 been most effective?

"JCARH125 is predominantly used to treat systemic juvenile idiopathic arthritis (sjia), but has also been demonstrated as a potential remedy for illnesses like neonatal-onset multisystem inflammatory disease (nomid) and interleukin-1 receptor antagonists."

Answered by AI

Are there any precedent attempts to utilize JCARH125 in medical research?

"Currently, seven Phase 3 trials are exploring the efficacy of JCARH125 and 33 other studies are being conducted. While there is a concentration of research in Paris, Ile-De-France, researchers have opened up additional 440 sites to better assess this drug's effects."

Answered by AI

To what degree is this clinical trial populated?

"At the time being, this research trial is not seeking participants. It was initially published in February 2018 and modified on November 4th 2022. There are 807 multiple myeloma studies still recruiting, as well 33 trials for JCARH125 that need patients to join them."

Answered by AI

How many locations are administering this trial?

"Right now, 26 medical sites are welcoming patients to this clinical trial. Major cities such as Duarte, Detroit and Los Angeles have locations in addition to many other lesser known places. Choosing the closest site is a sensible idea for those wishing to join so that commuting constraints can be minimized."

Answered by AI

Who else is applying?

What state do they live in?
Oregon
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma
2018. "Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03430011.
~24 spots leftby Apr 2025
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