Trial record 1 of 1 for:
NCT04673617
AB-101 as Monotherapy and In Combination With Rituximab in Patients With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
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| ClinicalTrials.gov Identifier: NCT04673617 |
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Recruitment Status :
Recruiting
First Posted : December 17, 2020
Last Update Posted : March 27, 2023
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Sponsor:
Artiva Biotherapeutics, Inc.
Information provided by (Responsible Party):
Artiva Biotherapeutics, Inc.
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Brief 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.
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; 2) to evaluate the potential clinical activity of AB-101 when given in combination with 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 has anti-cancer activity in patients.
Patients will be assigned to receive either AB-101 alone as monotherapy or in combination with 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non Hodgkin Lymphoma | Drug: AB-101 Drug: Rituximab Drug: Interleukin-2 Drug: Cyclophosphamide Drug: Fludarabine | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 80 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Plus Rituximab 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Rituximab
| Arm | Intervention/treatment |
|---|---|
| Experimental: Phase 1: Dose confirmation of AB-101 as monotherapy and in combination with rituximab |
Drug: AB-101
NK cell therapy Drug: Rituximab Anti-CD20 antibody therapy Drug: Interleukin-2 Immune cytokine Drug: Cyclophosphamide Lymphodepleting chemotherapy Drug: Fludarabine Lymphodepleting chemotherapy |
| Experimental: Phase 2: AB-101 given with rituximab to patients with B-cell NHL at the R2PD |
Drug: AB-101
NK cell therapy Drug: Rituximab Anti-CD20 antibody therapy Drug: Interleukin-2 Immune cytokine Drug: Cyclophosphamide Lymphodepleting chemotherapy Drug: Fludarabine Lymphodepleting chemotherapy |
Primary Outcome Measures :
- Phase 1, monotherapy: Safety and tolerability of AB-101 as monotherapy and in combination with 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, tolerability, and clinical activity of AB-101 in combination with rituximab.
- Phase 2: Determine the efficacy profile of AB-101 in combination with 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 |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Information from the National Library of Medicine
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
Contacts
| Contact: AB-101-01 Trial Operations | 858-267-4491 | ab-101-01-study-team@artivabio.com |
Locations
| United States, Alabama | |
| University of Alabama | Recruiting |
| Birmingham, Alabama, United States, 35249 | |
| Contact: Amitkumar Mehta, MD 205-966-8400 amitkumarmehta@uabmc.edu | |
| United States, California | |
| University of California, Irvine | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Blake Johnson 714-456-3476 blakej@hs.uci.edu | |
| Principal Investigator: Lauren C. Pinter-Brown, MD | |
| University of California San Diego Moores Cancer Center | Recruiting |
| San Diego, California, United States, 92093 | |
| Contact: Joseph Maroge 858-246-0682 jmaroge@health.ucsd.edu | |
| Principal Investigator: Ayad Hamdan, M.D. | |
| United States, Florida | |
| UF Health Shands Cancer Hospital | Recruiting |
| Gainesville, Florida, United States, 32608 | |
| Contact: Emma Hall Rosenau, BB(ASCP) SBB, MPH, CCRP 352-294-8938 roseeg@ufl.edu | |
| Principal Investigator: Erin Dean, MD | |
| United States, Georgia | |
| Blood and Marrow Transplant Group of Georgia at Northside Hospital | Recruiting |
| Atlanta, Georgia, United States, 30342 | |
| Contact: Caitlin Guzowski, MBA, MHA, CCRC 404-851-8523 caitlin.guzowski@northside.com | |
| Principal Investigator: Lawrence E Morris, Jr, MD | |
| United States, Illinois | |
| Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Rush Cancer Center Clinical Trials Office 312-226-2371 cancer_studies@rush.edu | |
| Principal Investigator: Sunita Nathan, MD | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Karen Parrott, RN, BSN 319-353-6347 karen-parrott@uiowa.edu | |
| Principal Investigator: Umar Farooq, MD | |
| United States, Kansas | |
| Cancer Center of Kansas | Recruiting |
| Wichita, Kansas, United States, 67214 | |
| Contact: Lisa Willems 316-613-4300 lisa.willems@cancercenterofkansas.com | |
| Contact: Pat Stone, RN 316-613-4313 Pat.stone@cancercenterofkansas.com | |
| Principal Investigator: Bassam I. Mattar, MD | |
| United States, Kentucky | |
| Norton Cancer Institute | Recruiting |
| Louisville, Kentucky, United States, 40241 | |
| Contact: Norton Cancer Institute Hematology 502-899-3366 Heme-NCIResearch@nortonhealthcare.org | |
| Principal Investigator: Joseph Maly, M.D. | |
| United States, Michigan | |
| Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Grace Bae 313-576-8030 baeg@karmanos.org | |
| Principal Investigator: Dipenkumar Modi, MD | |
| United States, Oregon | |
| Oregon Health Sciences Center | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: OHSU Clinical Trials Information Line 503-494-1080 trials@ohsu.edu | |
| Principal Investigator: Jennifer Saultz, D.O. | |
| United States, Pennsylvania | |
| Jefferson Health | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Natisha Muhmmad, MPH, CCRP 215-955-5769 | |
| Principal Investigator: Usama Gergis, MD | |
| Fox Chase Cancer Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Contact: Rashmi Khanal, M.D. 215-728-4300 Rashmi.Khanal@tuhs.temple.edu | |
| Principal Investigator: Rashmi Khanal, M.D. | |
| United States, Texas | |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Tarah Satterfield, MPH 214-820-6967 tarah.satterfield@bswhealth.org | |
| Principal Investigator: Houston Holmes, MD | |
Sponsors and Collaborators
Artiva Biotherapeutics, Inc.
Investigators
| Study Director: | Thorsten Graef, M.D., Ph.D. | Artiva Biotherapeutics |
| Responsible Party: | Artiva Biotherapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT04673617 |
| Other Study ID Numbers: |
AB-101-01 |
| First Posted: | December 17, 2020 Key Record Dates |
| Last Update Posted: | March 27, 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 |
Keywords provided by Artiva Biotherapeutics, Inc.:
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lymphoma NHL cell therapy rituximab NK cell |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Rituximab Fludarabine Interleukin-2 Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Immunological Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |