Data showed favorable safety profile, complete response rate and durability in the treatment of patients with relapsed or refractory indolent B-cell Non-Hodgkin Lymphoma
100% of patients with follicular lymphoma achieved a complete response; no occurrence of CRS above grade 1 and no ICANS of any grade
Complete responses observed in patients previously treated with CD19-targeted CAR T-cell therapy
Outpatient administration found to be feasible
“All nine patients have responded clinically to treatment in this multicenter trial and the safety and efficacy profile of MB-106 appears to be consistent with the original single-institution trial. It is especially encouraging that complete responses were observed in all patients with follicular lymphoma in this multicenter trial,” said
Highlights from the data include:
- All patients responded clinically to treatment with MB-106 (n=9); 100% overall response rate for patients with follicular lymphoma (“FL”) and Waldenstrom macroglobulinemia (“WM”)
- 100% of patients with FL (n=5) had a complete response; 1 very good partial response and 2 partial responses were observed in WM patients (n=3); and the hairy cell leukemia variant (“HCL-v”) patient experienced stable disease, with prolonged, ongoing independence from blood transfusions
- Complete responses observed in patients previously treated with CD19-targeted CAR T-cell therapy
- MB-106 has a tolerable safety profile in patients with indolent NHL, with no occurrence of CRS above grade 1, and no ICANS of any grade, despite not using prophylactic tocilizumab or dexamethasone
- Outpatient administration was allowed and found to be feasible
- MB-106 CAR T-cell expansion and persistence in patients was demonstrated
Efficacy (combined results for dose level 1 & 2)
Best Responsesto Date1 | Follicular Lymphoma (n=5) | Waldenstrom Macroglobulinemia (n=3) |
Overall response rate (ORR),2 n (%) | 5 (100%) | 3 (100%) |
Complete response (CR), n (%) | 5 (100%) | 0 |
Very good partial response (VGPR),3 n (%) | N/A | 1 (33%) |
Partial response (PR), n (%) | 0 | 2 (67%) |
Minor response,3 n (%) | N/A | 0 |
Stable disease (SD) | 0 | 0 |
- In WM patients, responses are evaluated using the 11th
International Workshop on WM (IWWM) criteria (Treon, 2023). In lymphoma patients, PET-CT-based responses are evaluated using the Lugano Classification (Cheson, 2014). - ORR is the rate of PR or better in follicular lymphoma. ORR is the rate of minor response or better in WM.
- VGPR and minor response are WM-specific response categories.
N/A = Not applicable
Safety
CRS and ICANS (combined results for dose level 1 & 2)
Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
CRS, n (%) | 5 (56%) | 0 | 0 | 0 |
ICANS | 0 | 0 | 0 | 0 |
- CRS = Cytokine release syndrome
- ICANS = Immune effector cell-associated neurotoxicity syndrome
- No related serious adverse events (SAEs) reported, apart from Grade 1 CRS.
- No prophylactic tocilizumab or dexamethasone was administered.
The data reported on nine patients from the indolent lymphoma arm of the multicenter clinical trial, including five patients with follicular lymphoma, three patients with Waldenstrom macroglobulinemia, and one patient with transfusion-dependent hairy cell leukemia variant. The patients had been treated with a median of 4 lines of prior therapy (range: 1-9), including 2 patients who had received prior CD19-directed CAR T-cell therapy and 1 patient who had received prior autologous stem cell transplant. The patients received one of two dose levels: dose level 1, 3.3×106 CAR T-cells/kg body weight, or dose level 2, 1.0×107 CAR T-cells/kg.
A link to the poster can be found on the Publications page of the
Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and certain of its scientists may benefit financially from this work in the future.
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