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Study of CAR T-cell Therapy in Acute Myeloid Leukemia and Multiple Myeloma

NCT04097301 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-01-19

Study results available
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Summary

The purpose of this first-in-man Phase I-IIa study is to evaluate the safety and antitumor activity of autologous CD44v6 CAR T-cells in patients with acute myeloid leukemia (AML) and multiple myeloma (MM).

Conditions

Interventions

DRUG

MLM-CAR44.1 T-cells at day 0 Single intravenous infusion

Lymphodepleting chemotherapy with cyclophosphamide (500 mg/m2) and fludarabine (30 mg/m2) daily from day -5 to day -3.

Sponsors & Collaborators

  • Horizon 2020 - European Commission

    collaborator OTHER

  • AGC Biologics S.p.A.

    lead INDUSTRY

Principal Investigators

  • Fabio Ciceri, MD · IRCCS San Raffaele

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-27
Primary Completion
2021-06-18
Completion
2021-06-18

Countries

  • Czechia
  • Italy

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 NCT04097301 on ClinicalTrials.gov