Clinical trial · Interventional
Mitoxantrone Hydrochloride Liposome Injection-containing Bridging Regimen and CD19-targeting CAR-T Therapies
Study on the Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Injection-containing Bridging Regimen in CD19-targeting CAR-T Therapies
NCT06220097CI-TRIAL-00092290active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Acute Lymphoblastic Leukemia | B Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| B-cell Lymphoma Refractory | Burkitt Lymphoma | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mitoxantrone hydrochloride liposome Injection-based bridging therapy+ Fludarabine-based chemotherapy +CD19 CAR-T Cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Effective of MHL injection-containing bridging regimens with CD19 CAR-T
- description
- After enrollment, all subjects will receive a combination regimen of mitoxantrone hydrochloride liposomal injection within 28 days to 7 days before CAR-T infusions will be included, including but not limited to the R-MINE regimen (mitoxantrone hydrochloride liposomal injection combined with rituximab, mesna, ifosfamide and etoposide), G-MINE regimen (mitoxantrone hydrochloride liposomal injection combined with obinutuzumab, mesna, ifosfamide and etoposide), MAE scheme (mitoxantrone hydrochloride liposomal injection combined with cytarabine, etoposide), etc.
- interventionNames
- Drug: Mitoxantrone hydrochloride liposome Injection-based bridging therapy+ Fludarabine-based chemotherapy +CD19 CAR-T Cells
Primary outcomes (1)
- measure
- The overall response rate (ORR) of patients after bridging therapy
- timeFrame
- After bridging therapy and before CD19 CAR-T infusion
- description
- The overall response rate (ORR) was based on the Lugano 2014 Lymphoma Efficacy Evaluation Criteria (Cheson 2014) and the 2021 version of the ALL Efficacy Evaluation Index
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.