Phase 1/2 Study of CD19 Chimeric Antigen Receptor T-cell (CD19 CAR-T; PL001) for Relapsed or Refractory B-cell Lymphoma

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

May 31, 2022

Primary Completion Date

December 31, 2026

Study Completion Date

March 31, 2027

Conditions
Diffuse Large B Cell LymphomaPrimary Mediastinal Large B Cell LymphomaLarge B-cell LymphomaFollicular Lymphoma Grade 3AFollicular Lymphoma Grade 3B
Interventions
BIOLOGICAL

CD19-targeted chimeric antigen receptor T-cell

"Drug: Fludarabine~patients will receive a lymphodepletion chemotherapy with Fludarabine 25 mg/m2/day IV for 3 days on Day-5 to Day-3(a safe window for a small subset of patients will be D -7 to D -3).~Drug: Cyclophosphamide~patients will receive a lymphodepletion chemotherapy with cyclophosphamide 300 mg/m2/day IV for 3 dys Day-5 to Day-3(a safe window for a small subset of patients will be D -7 to D -3).~Biological: CD19 CAR-T~CD19 CAR-T cells will be administered using as a single dose at 0.1-9\*10\^6 cells/kg on Day 0 after completion of the lymphodepletion chemotherapy. The body weight calculated for PL001 dose is the actual body weight on the day of leukapheresis."

Trial Locations (5)

710

NOT_YET_RECRUITING

Chi Mei Medical Center, Tainan City

11031

RECRUITING

Taipei Medical University - Taipei Medical University Hospital, Taipei

100225

RECRUITING

National Taiwan University Hospital, Taipei

112201

RECRUITING

Taipei Veterans General Hospital, Taipei

807377

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

All Listed Sponsors
lead

Pell Bio-Med Technology Co., Ltd.

INDUSTRY