PTCL, late-line¶

Abstract: 6508 · Session: Hematologic Malignancies — Lymphoma and Chronic Lymphocytic Leukemia (Oral), Tue Jun 2, 12:09–12:21 PM CT · Presenter: Meng Lv, MD, PhD (Peking University People's Hospital, Beijing) · Embargo: at presentation

At a glance¶

Sponsor: Peking University People's Hospital (Institute of Hematology)
PI / presenter: Meng Lv, MD, PhD
NCT ID: NCT06874946
Phase: Phase 1 (dose-escalation and expansion)
Design: First-in-human single-arm dose-escalation/expansion of an autologous dual-epitope (bispecific) nanobody anti-CD5 CAR-T
N: 18 evaluable
Primary endpoint(s): Safety/tolerability and overall response rate (ORR); RP2D determination
Comparator: None (single-arm)
Indication: Relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) / peripheral T-cell lymphoma (PTCL)
Line: Late-line, heavily pretreated

Headline result¶

Among 18 evaluable patients with relapsed/refractory T-ALL or PTCL, the dual-epitope nanobody anti-CD5 CAR-T produced an ORR of 77.8%, with 61.1% achieving CR / CRi / complete molecular response (CMR). At the recommended phase 2 dose, ORR was 100% and CR/CMR was 85.7%. Cytokine release syndrome occurred in 66.7% with no grade ≥3 events; one grade 1 ICANS was reported. Grade 3–4 immune-effector-cell-associated hematotoxicity was seen in 22.2% (early) and 27.8% of patients. The four non-responders showed low CAR-T expansion (peak <500 copies/µg genomic DNA), linking response to in-vivo expansion. No HR or p-values apply (single-arm phase 1).

Mechanism / class¶

Autologous CAR-T directed at CD5, a pan–T-cell antigen broadly expressed on T-ALL and PTCL. The construct uses a bispecific (dual-epitope) nanobody (VHH) binder targeting two distinct CD5 epitopes, an engineering strategy intended to deepen and stabilize antigen engagement and mitigate antigen escape. CD5-directed CAR products remain investigational; no CD5 CAR-T is approved. T-cell malignancy CAR-T development has been limited by fratricide, shared antigen expression on the CAR product, and immune escape — barriers this dual-epitope nanobody design is positioned to address.

Practice-changing?¶

Pending. Striking depth of response at RP2D (100% ORR, 85.7% CR/CMR) with no grade ≥3 CRS is highly promising in a population with no standard of care and dismal outcomes, but N is small (18), follow-up is early, and durability/bridging-to-transplant data are not yet mature. Confirmatory expansion needed before practice impact.

Cross-links¶

Other ASCO 2026 trials: Olverembatinib 2L CML-CP (heme, China-origin late-line)
AACR 2026: index

Sources¶

ASCO Meeting Library (J Clin Oncol 2026;44(suppl 16):6508): https://meetings.asco.org/abstracts-presentations/ — abstract 6508, doi:10.1200/JCO.2026.44.16_suppl.6508
CancerNetwork — Top Lymphoma Abstracts at ASCO 2026: https://www.cancernetwork.com/view/what-are-the-top-lymphoma-abstracts-at-asco-2026-
Oncology Central — A hematologist's guide to ASCO 2026: https://www.oncology-central.com/a-hematologists-guide-to-the-most-important-abstracts-at-asco-2026/
ClinicalTrials.gov NCT06874946: https://clinicaltrials.gov/study/NCT06874946