NCT05397496

Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies

Active, enrolled Phase 1 Last updated 17 March 2026

What this trial tests

Phase 1 trial testing PIT565 in B-cell Non-Hodgkin Lymphoma (B-NHL) in 61 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

3 October 2022

Primary endpoint
14 May 2026

14 May 2026

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	3 October 2022
Primary completion	14 May 2026
Estimated completion	14 May 2026
Sites	18 locations across France, Italy, Japan, Belgium, Israel, China, Singapore, United States

Drugs / interventions tested

• PIT565 — full drug profile →

Conditions studied

• B-cell Non-Hodgkin Lymphoma (B-NHL) — all drugs for B-cell Non-Hodgkin Lymphoma (B-NHL) →
• B-cell Acute Lymphoblastic Leukemia (B-ALL) — all drugs for B-cell Acute Lymphoblastic Leukemia (B-ALL) →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

Adults 18 to 100, any sex, with B-cell Non-Hodgkin Lymphoma (B-NHL) or B-cell Acute Lymphoblastic Leukemia (B-ALL). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an open-label, multicenter, phase I study, which primary objective is to characterize the safety and tolerability of PIT565 and to identify maximal tolerated doses (MTDs) and/or recommended doses (RDs), schedule and route of administration in relapsed and/or refractory B-cell Non-Hodgkin lymphoma (R/R B-NHL) and relapsed and/or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Logic-gated and contextual control of immunotherapy for solid tumors: contrasting multi-specific T cell engagers and CAR-T cell therapies.
   Nolan-Stevaux O, Smith R. · · 2024 · cited 29× · PMID 39606234 · DOI 10.3389/fimmu.2024.1490911
2. Stepping forward: T-cell redirecting bispecific antibodies in cancer therapy.
   Qin X, Ning W, Liu H, Liu X, et al · · 2024 · cited 28× · PMID 38828136 · DOI 10.1016/j.apsb.2024.03.027
3. Bi- and Tri-specific antibodies in non-Hodgkin lymphoma: current data and perspectives.
   Abou Dalle I, Dulery R, Moukalled N, Ricard L, et al · · 2024 · cited 23× · PMID 38272863 · DOI 10.1038/s41408-024-00989-w
4. Therapeutic antibodies in oncology: an immunopharmacological overview.
   Toledo-Stuardo K, Ribeiro CH, González-Herrera F, Matthies DJ, et al · · 2024 · cited 10× · PMID 39358613 · DOI 10.1007/s00262-024-03814-2
5. From Molecular Precision to Clinical Practice: A Comprehensive Review of Bispecific and Trispecific Antibodies in Hematologic Malignancies.
   Amoozgar B, Bangolo A, Habibi M, Cho C, et al · · 2025 · cited 8× · PMID 40508128 · DOI 10.3390/ijms26115319
6. Bispecific Antibodies in Hematologic Malignancies: Attacking the Frontline.
   Shastri T, Trabolsi A, Arumov A, Schatz JH. · · 2025 · cited 4× · PMID 40751114 · DOI 10.1007/s40259-025-00735-z
7. Bispecific Antibodies for Lymphoid Malignancy Treatment.
   Bisio M, Legato L, Fasano F, Benevolo Savelli C, et al · · 2024 · cited 4× · PMID 39796723 · DOI 10.3390/cancers17010094
8. The landscape of T-cell engagers for the treatment of follicular lymphoma.
   Rivas-Delgado A, Landego I, Falchi L. · · 2024 · cited 2× · PMID 39398477 · DOI 10.1080/2162402x.2024.2412869