Chimeric Antigen Receptor T Cell Therapy Redirected to CD4 (CD4CAR)as a Second Line Treatment for Chronic Myelomonocytic Leukemia, CMML.

Part of paid clinical trials in Miami, Florida.

Sponsor
Huda Salman
Study ID
NCT06071624
Phase
PHASE1
Status
Recruiting
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Conditions

  • Chronic Myelomonocytic Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CD4CAR — BIOLOGICAL
    CD4CAR cells transduced with a lentiviral vector to express the single-chain variable fragment (scFv) nucleotide sequence of the anti-CD4 molecule derived from humanized monoclonal ibalizumab and the intracellular domains of CD28 and 4-1BB co-activators fused to the CD3ζ T-cell activation signaling domain administered by IV infusions as a single dose

Study Details

This study is designed as a single arm open label traditional Phase I, 3+3, study of CD4-directed chimeric antigen receptor engineered T-cells (CD4CAR) in subjects with relapsed or refractory CMML. Specifically, the study will evaluate the safety and feasibility of CD4CAR T-cells.

Key Dates

Start date
Feb 21, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2043

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Redirected autologous T cells transduced with the anti-CD4 lentiviral vector (referred to as "CD4CAR" cells)

Primary Outcome Measure

Dose finding: Maximum tolerated dose (MTD) is defined as one dose level lower than the dose limiting toxicity (DLT) of the CD4CAR in CMML [ Time Frame: Day 0 through Day 28 post-infusion ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida 33136MiamiFlorida33136
Amer Beitinjaneh, MD
[email protected]
305-243-9127
Alessandro Perinuzzi
[email protected]
631-741-4990
Amer Beitinjaneh, MD (PRINCIPAL_INVESTIGATOR)
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202
Cristina Roach, RN
[email protected]
317-274-0840
Jennifer Schwartz, MD
[email protected]
317-278-9504
Huda Salman, MD, PhD (PRINCIPAL_INVESTIGATOR)
Albert Einstein Health NetworkThe BronxNew York10467
Joel Victor, BA
[email protected]
718-920-6680
R. Alejandro Sica, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Brianna Kammerer, RN
[email protected]
832-270-9423
Nicholas Short, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida 33136· Miami, FLIndiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, INAlbert Einstein Health Network· The Bronx, NYThe University of Texas MD Anderson Cancer Center· Houston, TX

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