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ASH 2025: New CAR T-Cell Therapies for Relapsed B-Cell Lymphoma
The 2025 American Society of Hematology’s Annual Meeting is currently underway in Orlando, Florida between December 6 to 9. At this conference, researchers testing new and existing treatments for blood cancers have gathered to present their latest results.
People whose lymphoma comes back or does not respond to treatment (relapsed/refractory) often need additional options. This article explains four early studies of newer CAR T-cell therapies and what their results could mean for people with B-cell lymphoma.
KITE-363 and KITE-753 target two markers at once
KITE-363 and KITE-753 are new types of CAR T-cell therapies. CAR-T is a treatment where a person’s own T cells are changed in a lab so they can better find and remove lymphoma cells. These two therapies are designed to recognize both CD19 and CD20, which are markers found on many B-cell lymphoma cells. Targeting two markers may help lower the chance that the lymphoma comes back if one marker disappears.
In this early study, people with relapsed/refractory B-cell lymphoma received KITE-363 or KITE-753 at different doses. Many patients had advanced-stage lymphoma, and some had already tried a prior CAR T-cell therapy.
At the highest doses of these treatments, for KITE-753, 79% of patients experienced complete remission. For those who received KITE-363, 78% of patients experienced complete remission. More than half of these patients continued to remain in remission at the median follow-up of 17.5 months. Although most patients experienced low blood counts, cases of cytokine release syndrome (CRS) and temporary brain-related side effects (ICANS) were uncommon and mostly mild. This suggests these dual-target CAR-T options may be promising for people whose lymphoma is difficult to treat.
Read this abstract: A Phase 1 study of KITE-753 or KITE-363 in patients with relapsed/refractory B-cell lymphoma: Initial safety and preliminary efficacy of KITE-753 and updated results of KITE-363. Data includes updated numbers presented during the ASH conference on December 6, 2025.
LUCAR-G39D: an off-the-shelf dual-target CAR-T
LUCAR-G39D is an allogeneic CAR T-cell therapy. Allogeneic means the T cells come from a donor without cancer instead of the lymphoma patient. This “off-the-shelf” approach may help people receive treatment faster, which can be important when lymphoma is growing quickly. LUCAR-G39D also targets both CD19 and CD20 to reduce the chance that lymphoma cells escape by losing one marker.
In this small phase 1 study, 10 adults with relapsed or refractory B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma and follicular lymphoma, received an infusion at different dose levels. Of all patients, 75% experienced a reduction in cancer cells, with 37.5% experiencing complete remission. At 14.6 months, 83.3% of patients remained in remission. Most side effects were related to low blood counts or mild to moderate infections. CRS occurred in 4 people and was mostly mild, and there were no cases of neurotoxicity or graft-versus-host disease, which can sometimes occur with donor cells. For patients who cannot access or wait for standard CAR T-cell therapy, an off-the-shelf option like LUCAR-G39D may provide another path in the future.
Read this abstract: A phase 1 study of lucar-G39D: A novel anti-CD20/CD19 dual-CAR allogeneic gamma delta T cells in adults with relapsed / refractory B-cell non-Hodgkin lymphoma (NHL). Data includes updated numbers presented during the ASH conference on December 6, 2025.
Azer-cel plus IL-2 after prior CAR-T relapse
Azer-cel is an allogeneic CD19-directed CAR T-cell therapy. It is made from healthy donor T cells. This study looked at azer-cel in people with large B-cell lymphoma (LBCL) who had previously received and then relapsed after an autologous CAR T-cell therapy. Autologous means the T cells were their own. These people often have very few effective options. Researchers added an under-the-skin shot of low-dose interleukin-2 (IL-2), a natural protein that can help T cells grow, for 14 days to see if it would help azer-cel work better.
In people treated with azer-cel plus low-dose IL-2, 81% of patients experienced a reduction in cancer cells, with 43.8% experiencing complete remission. Side effects such as CRS and ICANS were mostly mild or moderate. For individuals whose lymphoma returned after their first CAR T-cell therapy, this combination suggests that another CAR-T approach, supported by IL-2, may still offer meaningful benefit.
Read this abstract: Azer-cel, an allogeneic (allo) CD19 CAR T, in combination with low-dose interleukin-2 (IL-2) demonstrates clinical activity in patients with large B-cell lymphoma (LBCL) who relapsed after autologous (auto) CAR T. Data includes updated numbers presented during the ASH conference on December 6, 2025.
BAFFR-CAR T cells for people after CD19-targeted therapy
PMB-CT01 is a BAFFR-CAR T-cell therapy that targets BAFF-R, a receptor that helps B cells survive. Unlike CD19, BAFF-R is often still present even when CD19 is lost, including in people whose lymphoma has stopped responding to CD19-targeted therapies. This makes BAFF-R an appealing target for those who have already tried CD19-directed CAR T-cell therapy or have CD19-negative lymphoma.
In this early phase 1 study, seven people with different B-cell lymphomas, including mantle cell lymphoma and follicular lymphoma, received PMB-CT01 at one of two dose levels. Three months after the CAR-T infusion, 87.5% of patients experienced complete remission, and no patients have relapsed. All CRS events were mild, and only two people had mild ICANS that went away without steroids.
These results suggest BAFFR-CAR T cells may become an important option for individuals whose lymphoma no longer responds to CD19-targeted therapies.
Read this abstract: BAFFR-CAR T cells (PMB-CT01) demonstrate durable responses and manageable toxicities in relapsed/refractory B-cell lymphomas with prior CD19-directed therapy failure or CD19-negative disease. Data includes updated numbers presented during the ASH conference on December 6, 2025.
Key takeaways
These four early studies show several new CAR T-cell therapies that may help people with relapsed or refractory B-cell lymphoma, including those who have already tried a prior CAR-T. Dual-target therapies, off-the-shelf donor CAR-T, and new targets like BAFF-R may offer more chances for long-lasting responses with manageable side effects. Larger and longer studies are still needed, but these results give hope that more personalized and flexible CAR-T options are on the way.
This giving season, help HealthTree Foundation continue our mission
HealthTree Foundation is a non-profit organization dedicated to finding a cure for blood cancers. Our content, programs, research, and HealthTree Cure Hub® platform are designed to empower the blood cancer community and advance cures.
You can help us achieve this important mission this giving season! Thanks to a generous matching grant, all donations to HealthTree Foundation will be tripled.
Sources:
- A Phase 1 study of KITE-753 or KITE-363 in patients with relapsed/refractory B-cell lymphoma: Initial safety and preliminary efficacy of KITE-753 and updated results of KITE-363
- A phase 1 study of lucar-G39D: A novel anti-CD20/CD19 dual-CAR allogeneic gamma delta T cells in adults with relapsed / refractory B-cell non-Hodgkin lymphoma (NHL)
- Azer-cel, an allogeneic (allo) CD19 CAR T, in combination with low-dose interleukin-2 (IL-2) demonstrates clinical activity in patients with large B-cell lymphoma (LBCL) who relapsed after autologous (auto) CAR T
- BAFFR-CAR T cells (PMB-CT01) demonstrate durable responses and manageable toxicities in relapsed/refractory B-cell lymphomas with prior CD19-directed therapy failure or CD19-negative disease
The 2025 American Society of Hematology’s Annual Meeting is currently underway in Orlando, Florida between December 6 to 9. At this conference, researchers testing new and existing treatments for blood cancers have gathered to present their latest results.
People whose lymphoma comes back or does not respond to treatment (relapsed/refractory) often need additional options. This article explains four early studies of newer CAR T-cell therapies and what their results could mean for people with B-cell lymphoma.
KITE-363 and KITE-753 target two markers at once
KITE-363 and KITE-753 are new types of CAR T-cell therapies. CAR-T is a treatment where a person’s own T cells are changed in a lab so they can better find and remove lymphoma cells. These two therapies are designed to recognize both CD19 and CD20, which are markers found on many B-cell lymphoma cells. Targeting two markers may help lower the chance that the lymphoma comes back if one marker disappears.
In this early study, people with relapsed/refractory B-cell lymphoma received KITE-363 or KITE-753 at different doses. Many patients had advanced-stage lymphoma, and some had already tried a prior CAR T-cell therapy.
At the highest doses of these treatments, for KITE-753, 79% of patients experienced complete remission. For those who received KITE-363, 78% of patients experienced complete remission. More than half of these patients continued to remain in remission at the median follow-up of 17.5 months. Although most patients experienced low blood counts, cases of cytokine release syndrome (CRS) and temporary brain-related side effects (ICANS) were uncommon and mostly mild. This suggests these dual-target CAR-T options may be promising for people whose lymphoma is difficult to treat.
Read this abstract: A Phase 1 study of KITE-753 or KITE-363 in patients with relapsed/refractory B-cell lymphoma: Initial safety and preliminary efficacy of KITE-753 and updated results of KITE-363. Data includes updated numbers presented during the ASH conference on December 6, 2025.
LUCAR-G39D: an off-the-shelf dual-target CAR-T
LUCAR-G39D is an allogeneic CAR T-cell therapy. Allogeneic means the T cells come from a donor without cancer instead of the lymphoma patient. This “off-the-shelf” approach may help people receive treatment faster, which can be important when lymphoma is growing quickly. LUCAR-G39D also targets both CD19 and CD20 to reduce the chance that lymphoma cells escape by losing one marker.
In this small phase 1 study, 10 adults with relapsed or refractory B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma and follicular lymphoma, received an infusion at different dose levels. Of all patients, 75% experienced a reduction in cancer cells, with 37.5% experiencing complete remission. At 14.6 months, 83.3% of patients remained in remission. Most side effects were related to low blood counts or mild to moderate infections. CRS occurred in 4 people and was mostly mild, and there were no cases of neurotoxicity or graft-versus-host disease, which can sometimes occur with donor cells. For patients who cannot access or wait for standard CAR T-cell therapy, an off-the-shelf option like LUCAR-G39D may provide another path in the future.
Read this abstract: A phase 1 study of lucar-G39D: A novel anti-CD20/CD19 dual-CAR allogeneic gamma delta T cells in adults with relapsed / refractory B-cell non-Hodgkin lymphoma (NHL). Data includes updated numbers presented during the ASH conference on December 6, 2025.
Azer-cel plus IL-2 after prior CAR-T relapse
Azer-cel is an allogeneic CD19-directed CAR T-cell therapy. It is made from healthy donor T cells. This study looked at azer-cel in people with large B-cell lymphoma (LBCL) who had previously received and then relapsed after an autologous CAR T-cell therapy. Autologous means the T cells were their own. These people often have very few effective options. Researchers added an under-the-skin shot of low-dose interleukin-2 (IL-2), a natural protein that can help T cells grow, for 14 days to see if it would help azer-cel work better.
In people treated with azer-cel plus low-dose IL-2, 81% of patients experienced a reduction in cancer cells, with 43.8% experiencing complete remission. Side effects such as CRS and ICANS were mostly mild or moderate. For individuals whose lymphoma returned after their first CAR T-cell therapy, this combination suggests that another CAR-T approach, supported by IL-2, may still offer meaningful benefit.
Read this abstract: Azer-cel, an allogeneic (allo) CD19 CAR T, in combination with low-dose interleukin-2 (IL-2) demonstrates clinical activity in patients with large B-cell lymphoma (LBCL) who relapsed after autologous (auto) CAR T. Data includes updated numbers presented during the ASH conference on December 6, 2025.
BAFFR-CAR T cells for people after CD19-targeted therapy
PMB-CT01 is a BAFFR-CAR T-cell therapy that targets BAFF-R, a receptor that helps B cells survive. Unlike CD19, BAFF-R is often still present even when CD19 is lost, including in people whose lymphoma has stopped responding to CD19-targeted therapies. This makes BAFF-R an appealing target for those who have already tried CD19-directed CAR T-cell therapy or have CD19-negative lymphoma.
In this early phase 1 study, seven people with different B-cell lymphomas, including mantle cell lymphoma and follicular lymphoma, received PMB-CT01 at one of two dose levels. Three months after the CAR-T infusion, 87.5% of patients experienced complete remission, and no patients have relapsed. All CRS events were mild, and only two people had mild ICANS that went away without steroids.
These results suggest BAFFR-CAR T cells may become an important option for individuals whose lymphoma no longer responds to CD19-targeted therapies.
Read this abstract: BAFFR-CAR T cells (PMB-CT01) demonstrate durable responses and manageable toxicities in relapsed/refractory B-cell lymphomas with prior CD19-directed therapy failure or CD19-negative disease. Data includes updated numbers presented during the ASH conference on December 6, 2025.
Key takeaways
These four early studies show several new CAR T-cell therapies that may help people with relapsed or refractory B-cell lymphoma, including those who have already tried a prior CAR-T. Dual-target therapies, off-the-shelf donor CAR-T, and new targets like BAFF-R may offer more chances for long-lasting responses with manageable side effects. Larger and longer studies are still needed, but these results give hope that more personalized and flexible CAR-T options are on the way.
This giving season, help HealthTree Foundation continue our mission
HealthTree Foundation is a non-profit organization dedicated to finding a cure for blood cancers. Our content, programs, research, and HealthTree Cure Hub® platform are designed to empower the blood cancer community and advance cures.
You can help us achieve this important mission this giving season! Thanks to a generous matching grant, all donations to HealthTree Foundation will be tripled.
Sources:
- A Phase 1 study of KITE-753 or KITE-363 in patients with relapsed/refractory B-cell lymphoma: Initial safety and preliminary efficacy of KITE-753 and updated results of KITE-363
- A phase 1 study of lucar-G39D: A novel anti-CD20/CD19 dual-CAR allogeneic gamma delta T cells in adults with relapsed / refractory B-cell non-Hodgkin lymphoma (NHL)
- Azer-cel, an allogeneic (allo) CD19 CAR T, in combination with low-dose interleukin-2 (IL-2) demonstrates clinical activity in patients with large B-cell lymphoma (LBCL) who relapsed after autologous (auto) CAR T
- BAFFR-CAR T cells (PMB-CT01) demonstrate durable responses and manageable toxicities in relapsed/refractory B-cell lymphomas with prior CD19-directed therapy failure or CD19-negative disease
about the author
Megan Heaps
Megan joined HealthTree in 2022. She enjoys helping patients and their care partners understand the various aspects of the cancer. This understanding enables them to better advocate for themselves and improve their treatment outcomes.
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