B-Cell Lymphoma Refractory Clinical Trial
Official title:
Phase 2, Open-Label Study Evaluating Axi-Cel as a 2nd Line Therapy in Patients With Relapsed/Refractory Aggressive B-Non Hodgkin Lymphoma (B-NHL) Who Are Ineligible to Autologous Stem Cell Transplantation
This is a phase 2, open-label, multicenter study evaluating axicabtagene ciloleucel (axi-cel) as a 2nd line therapy in patients with Relapsed/Refractory aggressive B-NHL who are ineligible to receive Autologous Stem Cell Transplantation but eligible to receive CAR T-cell therapy.
Axicabtagene ciloleucel (axi-cel) is a chimeric antigen receptor (CAR) T-cell therapy directed against CD19 which has been approved for the treatment of relapse/refractory diffuse large B-cell lymphoma DLBCL and primary mediastinal large B-cell lymphoma (PMBCL) after 2 or more lines of systemic therapy. But administrating CAR T-cells earlier in the therapeutic strategy may be beneficial to patients. Axi-cel will improve the outcome of patients with DLBCL who are refractory or relapse early (i.e. within 1 year from end of treatment) after first-line therapy and who are not eligible for Autologous Stem Cell Transplantation (ASCT). Transplant-ineligible patients will include those who are deemed ineligible for high-dose chemotherapy and Hematopoietic Stem Cell Transplantation (HSCT) due to age, comorbidity, or prior ASCT. The primary endpoint will be complete metabolic response (CMR) at 3 months after Axi-cel infusion. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT05645744 -
Long-term Follow-up Study in Patients Previously Treated With a Mustang Bio CAR-T Cell Investigational Product.
|
||
| Active, not recruiting |
NCT03664635 -
MB-CART20.1 Lymphoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03853616 -
MB-CART19.1 r/r CD19+ B-cell Malignancies (BCM)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06445803 -
CD19/CD22 CAR-T Cells in Adults With R/R ALL or NHL
|
Phase 1 | |
| Recruiting |
NCT05360238 -
Study to Assess Safety, Tolerability and Efficacy of MB-106 in Patients With Relapsed or Refractory B-Cell NHL or CLL
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT04303247 -
CD19 and CD22 Dual-targeted CAR-T Cells for Relapsed or Refractory B-NHL
|
Early Phase 1 | |
| Recruiting |
NCT05318963 -
Targeting CD19/CD20/CD22 Triple-targeted Cell in Patients With Relapsed/Refractory B-cell Lymphoma
|
Phase 1 | |
| Not yet recruiting |
NCT05705570 -
A Phase I Clinical Trial Using Genetically Engineered Autologous T Cells to Express Chimeric Antigen Receptor (CAR) for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies
|
Phase 1 | |
| Active, not recruiting |
NCT04304040 -
A Study of MIL62 Combined With Orelabrutinib for the Treatment of R/R CD20+B Cell Lymphoma
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT05909098 -
Safety and Efficacy of Autologous NK Cell Adjuvant Therapy for Relapsed/Refractory Non-Hodgkin's B-cell Lymphoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04747093 -
Induced-T Cell Like NK Cells for B Cell Malignancies
|
Phase 1/Phase 2 | |
| Completed |
NCT05130489 -
CAR T Cell Therapy Related Cardiovascular Outcomes
|
||
| Recruiting |
NCT01786018 -
Thiotepa, Busulfan and Fludarabin for pt With Refractory/Early Relapsed Aggressive B-cell Non Hodgkin Lymphomas
|
Phase 2 | |
| Recruiting |
NCT06220097 -
Mitoxantrone Hydrochloride Liposome Injection-containing Bridging Regimen and CD19-targeting CAR-T Therapies
|
Phase 2 | |
| Active, not recruiting |
NCT04214886 -
CD19 Chimeric Antigen Receptor (CAR) T Cells for Adults With Recurrent or Refractory B Cell Malignancies
|
Phase 1 | |
| Completed |
NCT01535989 -
Study of Inotuzumab Ozogamicin + Temsirolimus in Patients With Relapsed or Refractory CD22+ B-cell NHLymphoma
|
Phase 1 |