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A Phase I/IIa Clinical Trial to Assess Feasibility, Safety and Antitumor Activity of Autologous SLAMF7 CAR-T Cells in Multiple Myeloma

NCT04499339 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-04-25

No results posted yet for this study

Summary

Multiple myeloma (MM) is a rare hematologic malignancy of aberrant plasma cells.

There is a high and currently unmet medical need for novel, innovative treatment concepts to improve the therapeutic outcome and prognosis of patients suffering from MM.

There is definitive evidence that MM is susceptible to immune-based therapies from pre-clinical investigations and early clinical trials.

CARAMBA-1 is a first-in-human clinical trial of adoptive immunotherapy with autologous signaling lymphocytic activation molecule F7 (SLAMF7) chimeric antigen receptor (CAR)-T cells in patients with advanced MM that have exhausted conventional therapies.

The CARAMBA-1 clinical trial is an open-label, non-randomized, multicenter clinical trial which combines a phase I dose-escalation part with a phase IIa dose-expansion part to assess feasibility, safety and anti-myeloma activity of SLAMF7 CAR-T cells.

The CARAMBA project and the CARAMBA-1 clinical trial are supported by the European Union in the Horizon 2020 research and innovation program.

Conditions

Interventions

DRUG

SLAMF7 CAR-T

Single infusion of autologous SLAMF7 CAR-T cells

Sponsors & Collaborators

  • European Union

    collaborator OTHER

  • Wuerzburg University Hospital

    lead OTHER

Principal Investigators

  • Prof. Michael Hudecek · University Hospital Wuerzburg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-22
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • France
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

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 NCT04499339 on ClinicalTrials.gov