RecruitingPhase 1NCT05949125

Phase 1 Study of Allo-RevCAR01-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies

Multicenter, Open-label, Phase 1 Study of Allo-RevCAR01-T-CD123 Consisting of Genetically Modified T Cells Carrying Reverse Chimeric Antigen Receptors (Allo RevCAR01 T) in Combination With CD123 Target Module (R-TM123) for the Treatment of Patients With Selected Hematologic Malignancies Positive for CD123


Sponsor

AvenCell Europe GmbH

Enrollment

80 participants

Start Date

Jan 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The Allo-RevCAR01-T-CD123 drug is a combination of a cellular component (Allo-RevCAR01-T) with a recombinant antibody derivative (R-TM123), which together form the active drug. The cellular component Allo-RevCAR01-T consists of an allogeneic human T-cell genetically multi-edited and expressing a reversed, universal chimeric antigen receptor (RevCAR) presenting an extracellular peptide epitope (RevCAR epitope). R-TM123 functions as a bridging module between Allo-RevCAR01-T and a CD123-expressing target cancer cell by selectively binding the RevCAR epitope and CD123.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new type of immune cell therapy called Allo-RevCAR01-T-CD123 in people with a type of blood cancer called AML (acute myeloid leukemia) that has returned or stopped responding to other treatments. The therapy uses specially engineered immune cells from a donor to attack cancer cells. **You may be eligible if...** - You are 18 or older and weigh at least 45 kg - You have been diagnosed with AML that has a protein called CD123 on the cancer cells - Your cancer has stopped responding to standard treatments or you cannot tolerate them - You have not had an allogeneic (donor) stem cell transplant in the last 2 months - Your heart, liver, and kidneys are functioning adequately - You are not pregnant or breastfeeding **You may NOT be eligible if...** - You have a specific type of AML called acute promyelocytic leukemia (APL) - You have had a stroke, seizure, or brain bleed in the past 12 months - You have Parkinson's disease or active epilepsy - You are HIV positive or have active hepatitis B or C - You have an active serious infection or active autoimmune disease requiring immunosuppression - You have had prior gene-modified cell therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCyclophosphamide (Non-IMP, Lymphodepletion)

Intravenous infusion over 3 days (d-5 to d-3)

OTHERFludarabine (Non-IMP, Lymphodepletion)

Intravenous infusion over 3 days (d-5 to d-3)

DRUGR-TM123

Intravenous infusion over 20 days

DRUGAllo-RevCAR01-T

Allo-RevCAR01-T will be administered as IV infusion on Treatment day 1.


Locations(11)

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Klinikum der Universität München

Munich, Bavaria, Germany

Universitätsklinikum Würzburg

Würzburg, Bavaria, Germany

Universitätsklinikum Marburg

Marburg, Hesse, Germany

Universitätsklinikum Dresden

Dresden, Saxony, Germany

Charité Universitätsmedizin Berlin

Berlin, Germany

Universitätsklinikum Köln

Cologne, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Erasmus University Medical Center

Rotterdam, Gelderland, Netherlands

Amsterdam University Medical Center

Amsterdam, HV, Netherlands

University Medical Center Groningen (UMCG)

Groningen, RB Groningen, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05949125


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