What You Should Know

  • The inMMyCAR trial Phase 1 open-label study explores KLN-1010, a therapy designed to do something previously only theorized in myeloma treatment: generate anti-BCMA CAR-T cells in vivo in a patient.
  • Unlike traditional CAR-T, where T cells must be collected, engineered in a manufacturing facility, expanded, shipped, and reinfused, KLN-1010 bypasses nearly every step. Instead, the therapy is delivered through a simple transfusion that targets T cells directly in vivo, converting them into functional CAR-T cells on the spot.
  • “You inject the patient with a virus that selectively goes after T cells and converts them into highly active CAR-T cells,” Myeloma specialist Dr. Sagar Lonial explains, adding that in vivo gene therapy is a “more rapid and easier process than the CAR-T process.”

One of the most talked-about breakthroughs at ASH 2025 came from Kelonia Therapeutics: KLN-1010. In the inMMyCAR trial, this first-of-its-kind therapy aims to generate CAR-T cells in vivo—eliminating apheresis, ex-vivo engineering, and weeks of manufacturing delays, all through a simple transfusion. This therapy creates anti-BCMA CAR-T cells directly inside the patient, bypassing the complex manufacturing process that has defined CAR-T therapy until now.

Myeloma specialist Dr. Sagar Lonial, Professor of Hematology at Emory University, explained the significance of this moment.

“This presentation is what we call an in vivo CAR. You inject the patient with a virus that selectively goes after T cells and converts them into highly active CAR-T cells. There’s no apheresis, no shipping cells anywhere, and no manufacturing delay. You don’t even need lymphodepletion chemotherapy. It really is a much more rapid and easier process than the CAR-T process.”

First-in-Human Results, Initial Data

Investigators are sharing early findings from the first three patients treated with KLN-1010. Although still very early, the data have captured widespread attention; all three patients became Minimal Residual Disease (MRD)-negative at one month. In the patient with the longest follow-up, MRD negativity persisted for at least three months. CAR-T cells expanded robustly despite the absence of lymphodepleting chemotherapy or ex-vivo manipulation. Memory-phenotype CAR-T cells, a potential indicator of durable benefit, were detected in all patients.

The early safety profile appears tolerable, though detailed adverse event data are still forthcoming.

These findings raise the possibility that a single infusion of KLN-1010 could generate potent, persistent CAR-T cells capable of eradicating detectable myeloma without the burdens of current CAR-T therapy.

When asked why this approach is drawing so much attention now, Dr. Lonial captured the excitement, “What we’re really encouraged by is that A) it worked, B) the MRD negativity in the first three patients was impressive, three out of three were MRD-negative with early follow-up, and C) it was safe.”

Dr. Lonial also acknowledged what many investigators have quietly wondered.

“One concern is always that you’re giving something to a patient without knowing exactly what will happen. But this has been modeled with other in vivo CARs,” noted Dr. Lonial, “this is probably one of the larger experiences we’ll see in the next year. The simplicity of the process is what has everybody excited.”

Why This Matters

If the inMMyCAR approach continues to perform well, the implications could be profound. Broader access to CAR-T in community hospitals, not just specialized centers, could deliver this therapy. Shorter wait times without months-long manufacturing times. Eliminating ex-vivo production could simplify logistics and lower expenses. Avoiding lymphodepleting chemotherapy may reduce side effects and shorten recovery times. In-body CAR-T manufacturing represents a potential leap toward scalable, widely available cell therapies. Experts at ASH are already describing this as one of the most anticipated developments of the year.

Future Questions 

With data from only three patients, major uncertainties remain. Will responses last? Will MRD negativity translate into longer progression-free survival or overall survival? As more patients are treated, will new toxicities emerge? How will this approach perform across the diverse myeloma population?

If the upcoming data continue to support what we’ve seen so far, KLN-1010 and the inMMyCAR platform could mark the beginning of a new era in myeloma therapy, one where CAR-T is faster to deliver, easier to access, and ultimately gentler on patients.