Fucosylated T Cells for Graft Versus Host Disease (GVHD) Prevention

PHASE1CompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

July 30, 2015

Primary Completion Date

October 6, 2020

Study Completion Date

October 6, 2020

Conditions
LeukemiaLymphoma
Interventions
DRUG

Rituximab

375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.

DRUG

Fludarabine

40 mg/m2 by vein on Days -8 to -5.

DRUG

Cyclophosphamide

50 mg/kg by vein on Day -8.

RADIATION

Total Body Radiation

2 Gy delivered on Day -4.

PROCEDURE

Fucosylated Regulatory T Cells

"Phase I: Participants treated at cell dose level 1: 1 x 10\^6/kg Fucosylated T-reg cells on Day -1.~Phase II: Participants treated at cell dose level 2: 1 x 10\^7/kg Fucosylated T-reg cells on Day -1."

PROCEDURE

Cord Blood Infusions

Cord blood transplant, MRD, or MUD infused on Day 0.

DRUG

Mycophenolate mofetil

15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.

DRUG

Sirolimus

12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.

PROCEDURE

Bone Marrow Aspiration

Bone marrow aspiration performed at 1, 3, 6, and 12 months after transplant to check status of disease.

DRUG

G-CSF

5 mcg/kg/day subcutaneously beginning on D+0, and continuing until absolute neutrophil count (ANC) is \> 500 x 10/L for 3 consecutive days.

PROCEDURE

Non-Fucosylated Regulatory T Cells

"Phase I: Participants treated at cell dose level 1: 1 x 10\^7/kg Non-Fucosylated T-reg cells on Day -1.~Phase II: Participants treated at cell dose level 2: 1 x 10\^7/kg Non-Fucosylated T-reg cells on Day -1."

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Cancer Prevention Research Institute of Texas

OTHER

lead

M.D. Anderson Cancer Center

OTHER

NCT02423915 - Fucosylated T Cells for Graft Versus Host Disease (GVHD) Prevention | Biotech Hunter | Biotech Hunter