Al-Ola A Abdallah, Associate Professor and Plasma Cell Disorder Program Director of the Division of HMCT at the University of Kansas Medical Center, shared a post on X:
“Bonus from ASH25 late abstract:
1. Breaking from ASH25!
LBA-1 unveils early results from in MMyCAR, the first-in-human Phase 1 study of KLN-1010, a novel in vivo anti-BCMA CAR-T gene therapy for RRMM.
2. What is KLN-1010?
An investigational in vivo CAR-T gene therapy given IV — no apheresis, no ex vivo manufacturing, no lymphodepletion. Uses an engineered LVV that selectively targets T cells via CD3. A true step toward an off-the-shelf CAR-T.
3. Who was treated?
Just 3 patients so far:
- Ages 61–72
- 3–4 prior lines (PI, IMiD, anti-CD38)
- All high-risk cytogenetics
- All BCMA-therapy naïve
No extramedullary disease. Time from consent → infusion: 13–18 days.
4. Safety Profile:
All had AEs mainly around infusion/expansion.
- IRRs in 2 patients (resolved)
- Grade 2 CRS in 2 patients
- No ICANS, no delayed neurotoxicity
- Minimal cytopenias
- No ≥Grade 3 thrombocytopenia or infections at 1 month
Overall: manageable + expected for CAR-T.
5. T-cell Expansion Without Chemo!
CAR-T expansion occurred even without lymphodepletion.
Peak ALC (day 13–18): 2.3, 7.37, and 43.1 × 10⁹/L
CAR+ cells: 22–72% of CD3+ T cells.
Memory-phenotype CAR-T detected in blood + BM through month 3.
6. Efficacy: (Early but Impressive!)
All 3 achieved MRD-negativity at month 1 (10⁻⁵–10⁻⁶ sensitivity).
One patient: sustained MRD-negative through month 3.
All had PR by IMWG at month 1 → deepened to VGPR by month 3.
No progression so far.
7. Why this matters:
Early signals show:
- Feasible off-the-shelf in vivo CAR-T
- Manageable toxicity
- Robust expansion
- Early deep responses
This could dramatically broaden access to CAR-T in MM.
8. Conclusion:
KLN-1010 shows promising clinical activity with limited cytopenias, no lymphodepletion, and early MRD-negative responses. The study is ongoing — more data coming soon!
LBA-1
MRD negative outcomes following a novel, in vivo gene therapy generating anti–B-cell maturation antigen (BCMA) CAR-T cells in patients with RRMM: Preliminary results from inMMyCAR, the first-in- human phase 1 study of KLN-1010.”
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