Mitoxantrone Hydrochloride Liposome Injection-containing Bridging Regimen and CD19-targeting CAR-T Therapies

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

February 1, 2022

Primary Completion Date

August 1, 2024

Study Completion Date

December 30, 2025

Conditions
B-cell Acute Lymphoblastic LeukemiaB-cell Lymphoma Refractory
Interventions
DRUG

Mitoxantrone hydrochloride liposome Injection-based bridging therapy+ Fludarabine-based chemotherapy +CD19 CAR-T Cells

Bridging therapies from enrollment before CD19 CAR-T infusion. A treatment regimen containing mitoxantrone hydrochloride liposome injection, including but not limited to the following recommended regimens: R-MINE regimen (rituximab + ifosfamide + mitoxantrone hydrochloride liposome + etoposide) G-MINE regimen (obinutuzumab + ifosfamide + mitoxantrone hydrochloride liposome + etoposide) MAE regimen (mitoxantrone liposome hydrochloride + cytarabine + etoposide) . The recommended dose of mitoxantrone liposome hydrochloride is not limited. For patients who achieve SD or better after one cycle of bridging treatment, it is up to the investigator to decide whether to receive CAR-T therapy. Fludarabine-based lymphodepletion chemotherapy was followed by CD19 CAR-T cells (relma-cel, axi-cel or humanized CAR19). Relma-cel and axi-cel will be infused according to the instructions. CART19 infusion is conducted at a dose of 1x10\^6/kg on day 0 and day 1 respectively.

Trial Locations (1)

430022

Union Hospital, Huazhong University of Science and Technology, Wuhan

Sponsors
All Listed Sponsors
lead

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

collaborator

CSPC Pharmaceutical Group Limited

INDUSTRY

NCT06220097 - Mitoxantrone Hydrochloride Liposome Injection-containing Bridging Regimen and CD19-targeting CAR-T Therapies | Biotech Hunter | Biotech Hunter