Chimeric Antigen Receptor T Cell Redirected to Target CD4 Positive Relapsed Refractory Acute Myeloid Leukemia (AML ) as a Bridge to Allogeneic Stem Cell Transplant

Part of paid clinical trials in Miami, Florida.

Sponsor
Huda Salman
Study ID
NCT06197672
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 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-redirected chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory AML. The study will evaluate safety in this patient population and also the presence of efficacy signal described by elimination of residual disease to qualify patients for stem cell transplant.

Key Dates

Start date
Mar 19, 2024
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2042

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

1. Dose finding: Maximum tolerated dose (MTD) is defined as one dose level lower than the Dose Limiting Toxicity (DLT) of the CD4CAR in AML. Optimal dose is highest safe dose that produces the most response. [ Time Frame: Day 0 through Day 28 post-infusion ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33136
Amer Beitinjaneh, MD
[email protected]
305-243-9127
Alessandro Perinuzz
[email protected]
630-741-4990
Amer Beitinjaneh, MD (PRINCIPAL_INVESTIGATOR)
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202
Tara Haney, RN
[email protected]
317-278-4184
Huda Salman, MD, PhD
[email protected]
317-278-9504
Riley Hospital for ChildrenIndianapolisIndiana46202
Courtney Spiegel, BS
[email protected]
(317) 278-3105
Jodi Skiles, 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 condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Miami Sylvester Comprehensive Cancer Center· Miami, FLIndiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, INRiley Hospital for Children· Indianapolis, INThe University of Texas MD Anderson Cancer Center· Houston, TX

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