AB-101 as Monotherapy and With Immunotherapy in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT04673617|
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : May 6, 2023
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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 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 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.
|Condition or disease||Intervention/treatment||Phase|
|Non Hodgkin Lymphoma||Drug: AB-101 Drug: Rituximab Drug: Interleukin-2 Drug: Cyclophosphamide Drug: Fludarabine Drug: Bendamustine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||93 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||March 29, 2021|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||November 2024|
Experimental: Phase 1: Dose confirmation of AB-101 as monotherapy, in combo with rituximab and in combo with BR
Phase 1: Dose confirmation of AB-101 as monotherapy, in combination with rituximab and in combination with bendamustine and rituximab
NK cell therapy
Anti-CD20 antibody therapy
Experimental: Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD
Phase 2: AB-101 given with rituximab or with bendamustine and rituximab to patients with B-cell NHL at the R2PD
NK cell therapy
Anti-CD20 antibody therapy
- Phase 1, monotherapy: Safety and tolerability of AB-101 as monotherapy, in combination with rituximab and in combination with bendamustine and rituximab, based on adverse events (AEs) [ Time Frame: From the ICF signature through 13 weeks after last study drug dose. ]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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Confirmed diagnosis of indolent or aggressive NHL of B-cell origin.
- 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.
- Patient must have disease that allows for response assessment using the Lugano classification criteria.
- Ability to understand and sign the ICF.
- 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.
- Prior allogeneic stem cell transplant.
- Positive HIV PCR test
- Positive for Hepatitis B or Hepatitis C
- 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 at least 4 months following lymphodepleting chemotherapy.
- Individuals who are pregnant or lactating are ineligible.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04673617
|Contact: AB-101-01 Trial Operationsemail@example.com|
|Study Director:||Thorsten Graef, M.D., Ph.D.||Artiva Biotherapeutics|
|Responsible Party:||Artiva Biotherapeutics, Inc.|
|Other Study ID Numbers:||
|First Posted:||December 17, 2020 Key Record Dates|
|Last Update Posted:||May 6, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Sensory System Agents
Peripheral Nervous System Agents