CD4CAR for CD4+ Leukemia and Lymphoma

Part of paid clinical trials in Miami, Florida.

Sponsor
Huda Salman
Study ID
NCT03829540
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • T-cell Leukemia
  • T-cell Lymphoma

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 Phase I, 3x3, multicenter study of CD4-directed chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory T-cell leukemia and lymphoma. Specifically, the study will evaluate the safety and feasibility of CD4CAR T-cells. Funding Source - FDA OOPD

Key Dates

Start date
Jul 9, 2020
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2041

Study Design

Enrollment
20 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

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 18-24 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Miami Sylvester Comprehensive Cancer CenterMiamiFlorida33136
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
Huda Salman, MD
[email protected]
317-278-9504.
Huda Salman, MD (PRINCIPAL_INVESTIGATOR)
Riley Hospital for ChildrenIndianapolisIndiana46202
Courtney Spiegel, BS
[email protected]
(317) 278-3105
Jodi Skiles, MD (SUB_INVESTIGATOR)
Albert Einstein Health NetworkNew YorkNew York10467
Roberto Sica, MD
[email protected]
718-920-4826
Karen Fehn, BA
[email protected]
718-405-8404
Roberto Sica, MD (PRINCIPAL_INVESTIGATOR)
Stony Brook Cancer CenterStony BrookNew York11794-
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, FLIndiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, INRiley Hospital for Children· Indianapolis, INAlbert Einstein Health Network· New York, NYStony Brook Cancer Center· Stony Brook, NYThe University of Texas MD Anderson Cancer Center· Houston, TX

Related Studies