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CAR T-cell Therapy

NEXI-002 T Cells for Multiple Myeloma

Phase 1 & 2
Waitlist Available
Led By Juan Varela, MD, PhD
Research Sponsored by NexImmune Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard-of-care for the patient's disease. Patients must also be willing and able to comply with study procedures, including the acquisition of specified research specimens
Age ≥ 18 years old & life expectancy > 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is being done to test the safety and effectiveness of a new experimental treatment for multiple myeloma called NEXI-002 T cell product. The treatment involves receiving a single infusion of the NEXI-002 T cell product after undergoing lymphodepleting therapy.

Eligible Conditions
  • Multiple Myeloma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events of Special Interest (AESIs) events
Adverse Events of Special Interest (AESIs) events (AEs) Reporting
Adverse Events of Special Interest (AESIs)events (AEs) Reporting (ICANS)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Safety Evaluation PhaseExperimental Treatment1 Intervention
Treatment with NEXI-002 T cells, derived from PBMCs of the patient
Group II: Dose Expansion PhaseExperimental Treatment1 Intervention
Dose Expansion Phase to further define the safety, tolerability and initial anti-tumor efficacy of the NEXI- 002 T cell product at the dose established from the Safety Evaluation Phase.

Find a Location

Who is running the clinical trial?

NexImmune Inc.Lead Sponsor
2 Previous Clinical Trials
58 Total Patients Enrolled
Kristi JonesStudy ChairNexImmune
Juan Varela, MD, PhDPrincipal InvestigatorAdvent Health
1 Previous Clinical Trials
22 Total Patients Enrolled

Frequently Asked Questions

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

In how many places is this research being conducted?

"There are a total of 6 sites where this study is taking place. They are situated in Detroit, Boston, Orlando and other cities. To reduce the amount of travelling required, patients should select the site which is closest to them."

Answered by AI

What is the total number of people enrolled in this trial?

"As stated in the inclusion criteria, 22 participants are required for this study. These volunteers can come from various locations, but must meet the specific prerequisites set out by the research team. For example, patients at Karmanos Cancer Institute in Detroit, Michigan and Dana-Farber Cancer Institute in Boston, Massachusetts are eligible to participate."

Answered by AI

Are volunteers still needed for this research project?

"That is accurate. The clinical trial, which began recruiting on August 17th 2020, as indicated by the listing on clinicaltrials.gov, is still in need of 22 patients at 6 different locations."

Answered by AI
~1 spots leftby Nov 2024