NCT03676504View on ClinicalTrials.gov

Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

September 7, 2018

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Acute Lymphoblastic Leukemia, AdultAcute Lymphoblastic Leukemia, PediatricChronic Lymphocytic LeukemiaDiffuse Large B Cell LymphomaFollicular LymphomaMantle Cell Lymphoma
Interventions
BIOLOGICAL

CD19.CAR T Cells

Dose Level 1: 1×10\^6 transduced cells/m\^2; Dose Level 2: 5×10\^6 transduced cells/m\^2; Dose Level 3: 20×10\^6 transduced cells/m\^2; Dose Level 4: 5x10\^7 transduced cells/m\^2; Dose Level 5: 10x10\^7 transduced cells/m\^2; Dose Level 6: 20x10\^7 transduced cells/m\^2

DRUG

Fludarabine

3 days of fludarabine 30 mg/m\^2/day

DRUG

Cyclophosphamide

3 days of cyclophosphamide 500 mg/m\^2/day

Trial Locations (2)

Unknown

RECRUITING

University Hospital Heidelberg, Heidelberg

RECRUITING

University Hospital Heidelberg, Heidelberg

All Listed Sponsors
lead

University Hospital Heidelberg

OTHER