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Trial of an Investigational Drug After Rejecting the Relapse of an Allogeneic Transplant

NCT05982275 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-05-14

No results posted yet for this study

Summary

Most patients with multiple myeloma (MM) die due to relapse resistant to current treatment, including treatment with anti-B cell maturation antigen (BCMA) CAR-T cells. To overcome some of the potential limitations of this therapy, a new and optimized Anti-BCMA CAR-T has been developed, with the aim of using it in patients with MM who relapse after Allogeneic Haematopoietic Haematopoietic Progenitor. This trial is a prospective phase I/II trial with a 3+3 design. Once Dose Limiting Toxicity is identified, Phase II will begin to assess the efficacy of the procedure.

Conditions

Interventions

GENETIC

CARTemis-1

A dose escalation design will be applied in successive patient cohorts until identification of Dose Limiting Toxicity (maximum dose: 6x10\^6 CAR-T/kg divided over 2 days).

Sponsors & Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • Jose-Antonio Perez-Simon, MD-PhD · Hospitales Universitarios Virgen del Rocío

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-30
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT05982275 on ClinicalTrials.gov