Anti-CD19 CAR-T Cells With Inducible Caspase 9 Safety Switch for B-cell Lymphoma

PHASE1RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 12, 2019

Primary Completion Date

March 22, 2027

Study Completion Date

March 22, 2043

Conditions
LymphomaLymphoma, B-CellImmune System DiseasesImmunoproliferative DisordersLymphatic Diseases
Interventions
BIOLOGICAL

iC9-CAR19 T cells

iC9-CAR19 T cells will be given by a licensed healthcare provider via intravenous injection over 5-10 minutes through either a peripheral or a central line.

DRUG

Bendamustine

70mg/m2 IV given as a daily infusion for 3 days per institutional guidelines 2 - 14 days prior to the T cell infusion.

DRUG

Fludarabine

30 mg/m2 given as a daily infusion for 3 days per institutional guidelines 2 - 14 days prior to the T cell infusion

DRUG

AP1903

"0.4 mg/kg of AP1903 as an IV infusion over 2 hrs for subjects who develop Grade 4 cytokine release syndrome (CRS) or grade ≥3 CRS that is unresponsive to standard of care interventions , subjects who develop grade ≥3 Immune effector cell-associated neurotoxicity syndrome (ICANS) that does not improve to grade ≤1 within 72 hours with standard of care interventions, and subjects with grade 4 ICANS of any duration that have evidence of cerebral edema and/or generalized convulsive status epilepticus.~Subjects in the expansion cohort who experience ≥ grade 2 CRS or ICANS that remains ≥ grade 2, twenty-four hours after an initial dose of the standard of care treatment may be part of the sub-study of rimiducid. These subjects will receive one of two assigned dose levels. DL1 and DL2 doses are 0.05 mg/kg and 0.01 mg/kg for subjects and DL1: 0.1 mg/kg and DL2: 0.01 mg/kg for subjects with ICANS."

DRUG

Cyclophosphamide

500 mg/m2/day administered by IV over 3 consecutive days

Trial Locations (1)

27599

RECRUITING

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill

All Listed Sponsors
collaborator

UNC Chapel Hill University Cancer Research Fund

UNKNOWN

collaborator

The V Foundation

OTHER

collaborator

M.D. Anderson Cancer Center

OTHER

lead

UNC Lineberger Comprehensive Cancer Center

OTHER