Non Hodgkin LymphomaPhase 1/2NCT04673617
AB-101 as Monotherapy and With Immunotherapy in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
A Phase 1/2 study testing AB-101, Rituximab and Interleukin-2 in people with Non Hodgkin Lymphoma, run by Artiva Biotherapeutics, Inc. at 21 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin Lymphoma
- What is being tested?
- AB-101, Rituximab and Interleukin-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 21 sitesUnited States
- Study dates
- 29 Mar 2021to 6 Oct 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of aggressive NHL of B-cell origin. For enrollment into the DLBCL specific cohort: DLBCL, High-grade B-cell Lymphoma or PMBCL.
- Patient must have progressed or demonstrated intolerance to at least two lines of FDA-approved therapies, one of which must have included anti-CD20 monoclonal antibody therapy. The following are permitted: Prior autologous hematopoietic stem cell transplantation, prior treatment with FDA-approved CAR-T therapy, and/or prior treatment with an investigational agent. Prior treatment(s) with an FDA-approved CAR-T cell therapy or other cell therapies is permitted as long the patients are not considered to be refractory to this previous cell therapy approach (defined as progression within 120 days from the infusion of the cell therapy approach).
- Patient must have disease that allows for response assessment using the Lugano classification criteria.
- Ability to understand and sign the ICF.
Who cannot join
- Active CNS lymphoma or CNS involvement unless there is a history of at least 3 months of sustained remission of treated disease.
- History of clinically significant structural cardiac disease.
- Cardiac ejection fraction of < 45% on echocardiogram or MUGA scan at screening assessment.
- Inadequate pulmonary function.
- History of a solid organ allograft, or an inflammatory or autoimmune disease likely to be exacerbated by IL-2.
- Ongoing uncontrolled systemic infections.
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- Positive HIV PCR test
- Positive for Hepatitis B or Hepatitis C
- Prior allogeneic stem cell transplant.
- Females of childbearing potential must be willing and able to use appropriate contraception for duration of trial and for 6 months following final AB-101 dose. Males must be sterile or commit to using appropriate contraception until 90 days following the final dose of AB-101.
- Individuals who are pregnant or lactating are ineligible.
- Patients who received a previous genetically modified cell therapy product (e.g., CD19 CAR-T), and progressed within 120 days from the time of the cell therapy infusion
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Artiva Clinical Trial Site
Atlanta, Georgia, 30342
Artiva Clinical Trial Site
Birmingham, Alabama, 35249
Artiva Clinical Trial Site
Chicago, Illinois, 60612
Artiva Clinical Trial Site
Columbus, Ohio, 43214
Artiva Clinical Trial Site
Dallas, Texas, 75246
Artiva Clinical Trial Site
Detroit, Michigan, 48201
Artiva Clinical Trial Site
Gainesville, Florida, 32608
Artiva Clinical Trial Site
Iowa City, Iowa, 52242
Artiva Clinical Trial Site
Lake Success, New York, 11042
Artiva Clinical Trial Site
Louisville, Kentucky, 40241
Artiva Clinical Trial Site
New York, New York, 11021
Artiva Clinical Trial Site
Orange, California, 92868
Artiva Clinical Trial Site
Philadelphia, Pennsylvania, 19107
Artiva Clinical Trial Site
Philadelphia, Pennsylvania, 19111
Artiva Clinical Trial Site
Portland, Oregon, 97239
Artiva Clinical Trial Site
Providence, Rhode Island, 02903
Artiva Clinical Trial Site
Richmond, Virginia, 23298
Artiva Clinical Trial Site
Salt Lake City, Utah, 84112
Artiva Clinical Trial Site
San Diego, California, 92093
Artiva Clinical Trial Site
Tucson, Arizona, 85719
Artiva Clinical Trial Site
Wichita, Kansas, 67214
About this study
Official title: A Multi-Center, Open-Label, Phase 1/2 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-101 Monotherapy and AB-101 With Immunotherapy in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma of B-Cell Origin.
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.
- Conditions
- Non Hodgkin Lymphoma
- Being tested
- AB-101, Rituximab, Interleukin-2, Cyclophosphamide, Fludarabine
- Keywords
- lymphoma, NHL, cell therapy, rituximab, NK cell, bendamustine
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-101Drug
NK cell therapy
RituximabDrug
Anti-CD20 antibody therapy
Interleukin-2Drug
Immune cytokine
CyclophosphamideDrug
Lymphodepleting chemotherapy
FludarabineDrug
Lymphodepleting chemotherapy
BendamustineDrug
Chemoimmunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR combo | Experimental | Phase 1: Dose confirmation of AB-101 as monotherapy, in combination with rituximab (including the DLBCL specific cohort) and in combination with bendamustine and rituximab Receives: Drug: AB-101; Drug: Rituximab; Drug: Interleukin-2; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine |
| Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD | Experimental | Phase 2: AB-101 given with rituximab or with bendamustine and rituximab to patients with B-cell NHL at the R2PD Receives: Drug: AB-101; Drug: Rituximab; Drug: Interleukin-2; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Safety and tolerability of AB-101 as monotherapy, and in combination with rituximab (including the DLBCL specific cohort) and in combination with bendamustine and rituximab.
Based on incidence, severity, and dose relationship of AEs and serious AEs (SAEs)
Measured: From the ICF signature through 13 weeks after last study drug dose.
Phase 1, combination therapy: AB-101 clinical activity, determined by ORR
Objective response rate (ORR) is defined as the proportion of patients with a documented complete response or partial response (CR + PR) in the absence of earlier disease progression.
Measured: From baseline disease assessment through end of study participation.
Phase 1, combination therapy: Identify the recommended Phase 2 dose (R2PD) for AB-101.
R2PD will be determined based on safety and tolerability of AB-101 in combination with rituximab or in combination with bendamustine and rituximab.
Measured: From ICF signature through 13 weeks after last study drug dose.
Phase 2: Determine the efficacy profile of AB-101 in combination with rituximab or in combination with bendamustine and rituximab when administered to patients with R/R NHL of B-cell origin.
The efficacy profile will be determined by the ORR.
Measured: From baseline disease assessment through end of study participation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start29 Mar 2021
- Primary completion6 Oct 2025
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artiva Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Subhashis Banerjee, M.D., Study director, Artiva Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04673617
- Sponsor's protocol ID
- AB-101-01
- Status last verified
- Mar 2026
- First submitted
- 4 Dec 2020
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: AlloNK is early in clinical development, next steps will be based on the progress of our data.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label, Phase 1/2 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-101 Monotherapy and AB-101 With Immunotherapy in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma of B-Cell Origin.
- ClinicalTrials.gov ID
- NCT04673617
- Acronym / sponsor ID
- AB-101-01
- Conditions
- Non Hodgkin Lymphoma
- Keywords
- lymphoma, NHL, cell therapy, rituximab, NK cell, bendamustine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Artiva Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR combo | Experimental | Drug: AB-101, Drug: Rituximab, Drug: Interleukin-2, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: BendamustinePhase 1: Dose confirmation of AB-101 as monotherapy, in combination with rituximab (including the DLBCL specific cohort) and in combination with bendamustine and rituximab |
| Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD | Experimental | Drug: AB-101, Drug: Rituximab, Drug: Interleukin-2, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: BendamustinePhase 2: AB-101 given with rituximab or with bendamustine and rituximab to patients with B-cell NHL at the R2PD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of aggressive NHL of B-cell origin. For enrollment into the DLBCL specific cohort: DLBCL, High-grade B-cell Lymphoma or PMBCL.
- Patient must have progressed or demonstrated intolerance to at least two lines of FDA-approved therapies, one of which must have included anti-CD20 monoclonal antibody therapy. The following are permitted: Prior autologous hematopoietic stem cell transplantation, prior treatment with FDA-approved CAR-T therapy, and/or prior treatment with an investigational agent. Prior treatment(s) with an FDA-approved CAR-T cell therapy or other cell therapies is permitted as long the patients are not considered to be refractory to this previous cell therapy approach (defined as progression within 120 days from the infusion of the cell therapy approach).
- Patient must have disease that allows for response assessment using the Lugano classification criteria.
- Ability to understand and sign the ICF.
Key exclusion criteria (12 listed)
- Active CNS lymphoma or CNS involvement unless there is a history of at least 3 months of sustained remission of treated disease.
- History of clinically significant structural cardiac disease.
- Cardiac ejection fraction of < 45% on echocardiogram or MUGA scan at screening assessment.
- Inadequate pulmonary function.
- History of a solid organ allograft, or an inflammatory or autoimmune disease likely to be exacerbated by IL-2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AB-101NK cell therapy | Drug | Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR combo, Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD |
| RituximabAnti-CD20 antibody therapy | Drug | Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR combo, Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD |
| Interleukin-2Immune cytokine | Drug | Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR combo, Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD |
| CyclophosphamideLymphodepleting chemotherapy | Drug | Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR combo, Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD |
| FludarabineLymphodepleting chemotherapy | Drug | Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR combo, Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD |
| BendamustineChemoimmunotherapy | Drug | Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR combo, Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD |
Primary outcome
Phase 1: Safety and tolerability of AB-101 as monotherapy, and in combination with rituximab (including the DLBCL specific cohort) and in combination with bendamustine and rituximab.
Time frame: From the ICF signature through 13 weeks after last study drug dose.
Based on incidence, severity, and dose relationship of AEs and serious AEs (SAEs)
Phase 1, combination therapy: AB-101 clinical activity, determined by ORR
Time frame: From baseline disease assessment through end of study participation.
Objective response rate (ORR) is defined as the proportion of patients with a documented complete response or partial response (CR + PR) in the absence of earlier disease progression.
Phase 1, combination therapy: Identify the recommended Phase 2 dose (R2PD) for AB-101.
Time frame: From ICF signature through 13 weeks after last study drug dose.
R2PD will be determined based on safety and tolerability of AB-101 in combination with rituximab or in combination with bendamustine and rituximab.
Phase 2: Determine the efficacy profile of AB-101 in combination with rituximab or in combination with bendamustine and rituximab when administered to patients with R/R NHL of B-cell origin.
Time frame: From baseline disease assessment through end of study participation.
The efficacy profile will be determined by the ORR.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No. AlloNK is early in clinical development, next steps will be based on the progress of our data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Subhashis Banerjee, M.D. study director
Artiva Biotherapeutics
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AB-101, Rituximab and Interleukin-2 in people with Non Hodgkin Lymphoma, run by Artiva Biotherapeutics, Inc. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Safety and tolerability of AB-101 as monotherapy, and in combination with rituximab (including the DLBCL specific cohort) and in combination with bendamustine and rituximab. (time frame: From the ICF signature through 13 weeks after last study drug dose.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.