NCT04673617

AB-101 as Monotherapy and With Immunotherapy in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

Completed Phase 1, PHASE2 Last updated 3 April 2026

What this trial tests

Phase 1, PHASE2 trial testing AB-101 in Non Hodgkin Lymphoma in 45 participants. Completed in 6 October 2025.

Timeline

29 March 2021

Primary endpoint
6 October 2025

6 October 2025

Quick facts

Lead sponsor	Artiva Biotherapeutics, Inc.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	29 March 2021
Primary completion	6 October 2025
Estimated completion	6 October 2025
Sites	21 locations across United States

Drugs / interventions tested

• AB-101
• Rituximab — full drug profile →
• Interleukin-2
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →
• Bendamustine (BENDAMUSTINE) — full drug profile →

Conditions studied

• Non Hodgkin Lymphoma — all drugs for Non Hodgkin Lymphoma →

Sponsor

Artiva Biotherapeutics, Inc.

Who can join

18 and older, any sex, with Non Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

AB-101 is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that are known to kill cancer cells.

This clinical trial will enroll patients with relapsed/refractory non-Hodgkin lymphoma of B-cell origin and is conducted in two phases. The primary objectives of Phase 1 are as follows: 1) to evaluate the safety of AB-101 given alone or in combination with rituximab (including the DLBCL specific cohort) or in combination with bendamustine and rituximab; 2) to evaluate the potential clinical activity of AB-101 when given in combination with rituximab or in combination with bendamustine and rituximab (combination cohorts only); and 3) to identify the recommended Phase 2 dose (RP2D). The primary objective of Phase 2 is to determine whether AB-101 in combination with rituximab or in combination with bendamustine and rituximab has anti-cancer activity in patients.

Patients will be assigned to receive either AB-101 alone as monotherapy, in combination with rituximab (including DLBCL specific cohort) or in combination with bendamustine and rituximab. All patients will receive at least 1 treatment cycle of AB-101, followed by scheduled assessments of overall health and tumor response. Patients receiving AB-101 in combination with rituximab may receive up to 3 additional cycles of treatment. Patients receiving AB-101 in combination with bendamustine and rituximab may receive up to 5 additional cycles of treatment. Patients enrolled into the DLBCL specific cohort receiving AB-101 in combination with rituximab may receive up to 3 cycles of treatment.

Publications & conference data

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

1. Natural killer cells in clinical development as non-engineered, engineered, and combination therapies.
   Lamers-Kok N, Panella D, Georgoudaki AM, Liu H, et al · · 2022 · cited 125× · PMID 36348457 · DOI 10.1186/s13045-022-01382-5
2. Bispecific killer cell engager with high affinity and specificity toward CD16a on NK cells for cancer immunotherapy.
   Nikkhoi SK, Li G, Eleya S, Yang G, et al · · 2022 · cited 41× · PMID 36685519 · DOI 10.3389/fimmu.2022.1039969
3. NK cells in the brain: implications for brain tumor development and therapy.
   Balatsoukas A, Rossignoli F, Shah K. · · 2022 · cited 27× · PMID 35078713 · DOI 10.1016/j.molmed.2021.12.008
4. Allogeneic Chimeric Antigen Receptor Therapy in Lymphoma.
   Khurana A, Lin Y. · · 2022 · cited 14× · PMID 35212892 · DOI 10.1007/s11864-021-00920-6
5. Harnessing natural killer cells for refractory/relapsed non-Hodgkin lymphoma: biological roles, clinical trials, and future prospective.
   Bakhtiyaridovvombaygi M, Yazdanparast S, Kheyrandish S, Safdari SM, et al · · 2024 · cited 6× · PMID 39020411 · DOI 10.1186/s40364-024-00610-z
6. Targeting KIR as a novel approach to improve CAR-NK cell function.
   Graham LV, Fisher JG, Khakoo SI, Blunt MD. · · 2023 · cited 5× · PMID 38229912 · DOI 10.20517/jtgg.2023.25
7. The Role of Killer Ig-like Receptors in Diseases from A to Z.
   Agnello L, Masucci A, Tamburello M, Vassallo R, et al · · 2025 · cited 4× · PMID 40244151 · DOI 10.3390/ijms26073242
8. Beyond autologous <i>ex vivo</i> CAR-expressing cell therapies: Toward allogeneic and nucleated cell-free delivery systems of CAR.
   Rallis KS, Dionisio LM, Tarannum M, Romee R, et al · · 2026 · PMID 41783358 · DOI 10.1016/j.omton.2026.201155