Lyell Immunopharma said on November 4, 2026, that its experimental cell therapy ronde-cel made cancer shrink in 91% of 44 people with large B-cell lymphoma that had come back or stopped responding to treatment, and that 77% had no detectable cancer after treatment1. The figures come from two summaries, called abstracts, accepted for the American Society of Hematology (ASH) meeting in New Orleans on December 12-15, 20261. They have not yet been published in a peer-reviewed journal.
Large B-cell lymphoma is an aggressive cancer of B cells, a type of white blood cell. Ronde-cel is a CAR-T therapy: a patient’s own immune cells, called T cells, are collected and changed in a lab so they can recognize cancer cells, then given back in a single infusion through a vein2. The infusion follows three days of chemotherapy with fludarabine and cyclophosphamide, drugs used to make room for the new cells2.
What the company reported
The main numbers come from PiNACLE, the trial Lyell hopes will support its approval request. It enrolls people whose lymphoma has already been treated at least twice, which doctors call third-line or later12. As of a June 18, 2026 data cutoff, 58 people had received ronde-cel1. Their median age was 64. About half had primary refractory disease, meaning their cancer never responded to the first treatment, and 64% had not responded to their most recent treatment1.
Of the 44 people who could be assessed 84 days after treatment, 40 saw their cancer shrink (the overall response rate) and 34 had a complete response, meaning scans showed no remaining cancer1. Among those with a complete response, the company estimates 92% were still in complete response at six months and 75% at 12 months1.
Lyell also reported a second group from its earlier-stage trial: 43 people treated after only one prior therapy, 86% of whom had primary refractory disease1. Of 37 who could be assessed at day 84, 35 responded (95%) and 28 had no detectable cancer (76%)1. Together, the two groups make up the “more than 80 patients” in the company’s announcement1.
How long the results have lasted, and side effects
Progression-free survival is the time people live without their cancer getting worse. In the third-line-or-later group, the median, or midpoint, had not been reached, which means fewer than half had seen their cancer worsen when the data were cut1. Lyell estimated that 76%, 63% and 54% of patients were alive without their cancer worsening at six, 12 and 24 months1. The typical follow-up for this measure was 12 months1, so the two-year figure rests on few patients. In the second-line group, the estimates were 75% at six months and 55% at 12 months, with a typical follow-up of nine months1.
CAR-T therapies can cause two well-known side effects. One is cytokine release syndrome (CRS), an immune overreaction. The other is a set of nerve and brain problems called ICANS. The company said no patient in either group had severe (grade 3 or higher) CRS1. Milder CRS was common: in the main trial, 48% had grade 1 and 22% had grade 21. Severe ICANS occurred in 9% of patients in each group1.
In June, at a European blood cancer meeting, Lyell reported safety data on 108 treated patients. About 59% received a steroid, dexamethasone, to prevent reactions. Severe ICANS occurred in 8% of those who got the steroid and 16% of those who did not3. That comparison was not randomized, so it cannot show the steroid caused the difference. The company also reported that it successfully made the therapy for 97% of these patients3.
What it does not show yet
PiNACLE is a single-arm trial, meaning every participant gets ronde-cel and there is no comparison group1. Without one, the results cannot show whether ronde-cel does better than the CAR-T therapies already approved for this cancer. All of the figures are the company’s own summaries of abstracts, and outside researchers have not yet reviewed the full data.
The numbers are also early. The planned trial size is larger than the group reported now. The registry description says PiNACLE will expand to about 120 participants2, and Lyell expects the full pivotal data in mid-20274. People in the trial are followed for about two years after treatment, then for up to 15 years2. Durability beyond one year is still based on estimates from a small number of people.
The 44 assessed patients are also fewer than the 58 treated1, because not everyone had reached the day-84 assessment. Results can shift as more patients are added. Lyell said updated results with more patients and longer follow-up will be shown at ASH1.
What makes this therapy different
Approved CAR-T therapies for this cancer look for one marker on B cells, called CD19. Ronde-cel is designed to recognize either CD19 or CD20, a second marker, and to attack with full strength when it finds either one4. The idea is that cancer cells that lose or hide one marker can still be caught by the other. Lyell’s June data included lab analysis it said supports this approach for cancers with low levels of a marker3.
The manufacturing process also selects for T cells carrying a marker called CD62L. The company says this produces more “memory” style T cells that may last longer in the body4. In the June analysis, cells with these memory features were more common in products given to patients whose responses lasted more than 12 months than in products given to patients whose cancer progressed3. That is an association in a small group, not proof of cause.
Who is behind it
Ronde-cel, also known as LYL314, is developed and paid for by Lyell Immunopharma of South San Francisco, which sponsors the trials56. The early-stage trial began in May 2023 and plans to enroll about 270 people in total6. On the same day as the data, Lyell announced an $80 million private financing and reported about $194 million in cash and investments as of September 30, 2026. The company said that money should fund operations into 20284.
Company leaders described the results in strong terms. Chief Medical Officer Jarrad Aguirre said:
We believe the high complete response rates and durability of remissions observed with ronde-cel in both the second-line and third- or later-line settings, including in patients with high-risk disease, are impressive.
He made that statement in the company’s announcement1. The US Food and Drug Administration (FDA) has given ronde-cel Regenerative Medicine Advanced Therapy and Fast Track designations, which can speed up review, for third-line-or-later use. It also gave the first of those designations for second-line use1. These designations are not approvals.
What to watch next
The next public look at the data is the ASH meeting in December, where the main trial results will be given as an oral presentation and the second-line results as a poster1. Lyell expects PiNACLE to finish enrolling by the end of 2026 and to file for FDA approval in the second half of 20274.
A bigger test is PiNACLE-H2H, a randomized trial in which patients are assigned by chance to ronde-cel or to one of two approved CAR-T therapies, axi-cel (Yescarta) or liso-cel (Breyanzi)5. It plans to enroll about 400 people at second line. Its main measure is event-free survival, the time until the cancer worsens or another set event happens5. The company said that trial is still enrolling4. A direct comparison like this is the kind of result that could show whether a two-target design adds anything over current options.
