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ACTIVE NOT RECRUITING

NCT06220097

PHASE2

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

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

View on ClinicalTrials.gov

Summary

The goal of this open, single-arm practical, phase II, clinical study is to evaluate the efficacy and safety of the mitoxantrone hydrochloride liposome injection-containing regimens in bridging therapies of CD19 CAR-T cells. The main question it aims to answer is: • the efficacy of the mitoxantrone hydrochloride liposome injection-containing combination regimens in bridging therapies of CD19 CAR-T cells. Participants will receive combination bridging regimens including mitoxantrone hydrochloride liposomal injection and CAR-T cell therapy to see if the combination regimens have a positive effect on the efficacy of bridging therapies.

Official title: Study on the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection-containing Bridging Regimen in CD19-targeting CAR-T Therapies

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-02-01

Completion Date

2025-12-30

Last Updated

2025-07-17

Healthy Volunteers

Conditions

B-cell Acute Lymphoblastic Leukemia B-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.

Inclusion Criteria: 1. Aged ≥ 18 years and \<75 years. 2. Eastern Cooperative Oncology Group score≤ 2. 3. Clinically diagnosed refractory or relapsed B-cell malignancies. Relapse refers to "relapse after a complete response (CR) from initial chemotherapy"; refractory refers to "diagnosis can be made if any of the following are met:(1) tumor shrinkage of \<50% or disease progression (PD) after standard chemotherapy; (2) CR is achieved by standard chemotherapy but relapses within six months, (3) 2 or more recurrences after CR, (4) recurrence after hematopoietic stem cell transplantation"; B-cell malignancies include the following 3 categories: (1) B-cell acute lymphoblastic leukemia (B-ALL); (2) indolent B-cell lymphoma (CLL, FL, MZL); (3) aggressive B-cell lymphoma (DLBCL, BL, MCL). 4. Flow cytometry (FCM) or immunohistochemistry showed positive CD19 expression in tumor cells; 5. Organ function needs to meet the following conditions: 1\) EF \>50%, and there is no obvious abnormality on ECG; 2) SpO2≥90%； 3) Cr≤2.5 ULN; 4) ALT and AST≤5 ULN, TBil≤3 ULN; 6. Negativity of blood pregnancy test for women, and participants use effective methods of contraception until the last follow-up. 7. The patient or his or her legal guardian voluntarily participates in and signs an informed consent form. Exclusion Criteria: 1. Prior treatment with doxorubicin or other anthracyclines with a total cumulative dose of doxorubicin \>360 mg/m2 (other anthracyclines convert 1 mg of doxorubicin to 2 mg epirubicin). 2. Hypersensitivity to any of the study drugs or their components. 3. Concomitant other diseases that are not effectively controlled, including but not limited to persistent or poorly controlled infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, poorly controlled pulmonary diseases, or psychiatric disorders. 4. Investigators judge patients with central nervous system involvement who may be at high risk of receiving bridging therapy and CD19 CAR-T cell treatment. 5. Participants with other active malignancies within five years. 6. Patients with relapse after allogeneic hematopoietic stem cell transplantation who have had grade 3\~4 acute graft-versus-host response (GVHD). 7. Patients who are pregnant or breast-feeding. 8. Active autoimmune disease requiring systemic immunosuppressive therapy. 9. Other conditions considered to increase the risk to the subject or interfere with the results of the trial by the researcher.

Locations (1)

Union Hospital, Huazhong University of Science and Technology

Wuhan, Hubei, China