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CAR- PRISM (PRecision Intervention Smoldering Myeloma)

NCT05767359 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-12

No results posted yet for this study

Summary

The goal of this research study is to test if ciltacabtagene autoleucel (cilta-cel) is safe and effective in treating participants with high-risk, smoldering myeloma.

The names of the treatment interventions used in this study are:

* Cilta-cel (or chimeric antigen receptor T cells)
* Cyclophosphamide (a lymphodepleting chemotherapy)
* Fludarabine (a lymphodepleting chemotherapy)

Conditions

Interventions

DRUG

Ciltacabtagene Autoleucel

Genetically modified autologous T-cell immunotherapy, via intravenous infusion per protocol.

DRUG

Cyclophosphamide

Lymphodepleting conditioning regimen, nitrogen mustard-derivative, via intravenous infusion per standard care.

DRUG

Fludarabine Phosphate

Lymphodepleting conditioning regimen, synthetic purine nucleoside, via intravenous infusion per standard care.

Sponsors & Collaborators

Principal Investigators

  • Irene Ghobrial, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-19
Primary Completion
2025-12-15
Completion
2040-01-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05767359 on ClinicalTrials.gov