Studies
| Study First Submitted Date | 2020-12-04 |
| Study First Posted Date | 2020-12-17 |
| Last Update Posted Date | 2023-08-09 |
| Start Month Year | March 29, 2021 |
| Primary Completion Month Year | November 2024 |
| Verification Month Year | August 2023 |
| Verification Date | 2023-08-31 |
| Last Update Posted Date | 2023-08-09 |
Facilities
| Sequence: | 200702461 | Sequence: | 200702462 | Sequence: | 200702463 | Sequence: | 200702464 | Sequence: | 200702465 | Sequence: | 200702466 | Sequence: | 200702467 | Sequence: | 200702468 | Sequence: | 200702469 | Sequence: | 200702470 | Sequence: | 200702471 | Sequence: | 200702472 | Sequence: | 200702473 | Sequence: | 200702474 | Sequence: | 200702475 | Sequence: | 200702476 | Sequence: | 200702477 | Sequence: | 200702478 |
| Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting |
| Name | University of Alabama | Name | The University of Arizona Cancer Center – North Clinic | Name | University of California, Irvine | Name | University of California San Diego Moores Cancer Center | Name | UF Health Shands Cancer Hospital | Name | Blood and Marrow Transplant Group of Georgia at Northside Hospital | Name | Rush University Medical Center | Name | University of Iowa Hospitals and Clinics | Name | Cancer Center of Kansas | Name | Norton Cancer Institute | Name | Karmanos Cancer Institute | Name | Northwell Health/R. J. Zuckerberg Cancer Center | Name | Weill Cornell Medicine | Name | Oregon Health Sciences Center | Name | Jefferson Health | Name | Fox Chase Cancer Center | Name | Texas Oncology – Baylor Charles A. Sammons Cancer Center | Name | Huntsman Cancer Institute, University of Utah |
| City | Birmingham | City | Tucson | City | Orange | City | San Diego | City | Gainesville | City | Atlanta | City | Chicago | City | Iowa City | City | Wichita | City | Louisville | City | Detroit | City | Lake Success | City | New York | City | Portland | City | Philadelphia | City | Philadelphia | City | Dallas | City | Salt Lake City |
| State | Alabama | State | Arizona | State | California | State | California | State | Florida | State | Georgia | State | Illinois | State | Iowa | State | Kansas | State | Kentucky | State | Michigan | State | New York | State | New York | State | Oregon | State | Pennsylvania | State | Pennsylvania | State | Texas | State | Utah |
| Zip | 35249 | Zip | 85719 | Zip | 92868 | Zip | 92093 | Zip | 32608 | Zip | 30342 | Zip | 60612 | Zip | 52242 | Zip | 67214 | Zip | 40241 | Zip | 48201 | Zip | 11042 | Zip | 11021 | Zip | 97239 | Zip | 19107 | Zip | 19111 | Zip | 75246 | Zip | 84112 |
| Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States |
Facility Contacts
| Sequence: | 28202589 | Sequence: | 28202590 | Sequence: | 28202591 | Sequence: | 28202592 | Sequence: | 28202593 | Sequence: | 28202594 | Sequence: | 28202595 | Sequence: | 28202596 | Sequence: | 28202597 | Sequence: | 28202598 | Sequence: | 28202599 | Sequence: | 28202600 | Sequence: | 28202601 | Sequence: | 28202602 | Sequence: | 28202603 | Sequence: | 28202604 | Sequence: | 28202605 | Sequence: | 28202606 | Sequence: | 28202607 |
| Facility Id | 200702461 | Facility Id | 200702462 | Facility Id | 200702463 | Facility Id | 200702464 | Facility Id | 200702465 | Facility Id | 200702466 | Facility Id | 200702467 | Facility Id | 200702468 | Facility Id | 200702469 | Facility Id | 200702469 | Facility Id | 200702470 | Facility Id | 200702471 | Facility Id | 200702472 | Facility Id | 200702473 | Facility Id | 200702474 | Facility Id | 200702475 | Facility Id | 200702476 | Facility Id | 200702477 | Facility Id | 200702478 |
| Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | backup | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary |
| Name | Amitkumar Mehta, MD | Name | Abhijeet Kumar, MD | Name | Blake Johnson | Name | Joseph Maroge | Name | Emma Hall Rosenau, BB(ASCP) SBB, MPH, CCRP | Name | Caitlin Guzowski, MBA, MHA, CCRC | Name | Rush Cancer Center Clinical Trials Office | Name | Karen Parrott, RN, BSN | Name | Lisa Willems | Name | Pat Stone, RN | Name | Norton Cancer Institute Hematology | Name | Grace Bae | Name | Ruthee-Lu Bayer, MD | Name | Tsiporah Shore | Name | OHSU Clinical Trials Information Line | Name | Natisha Muhmmad, MPH, CCRP | Name | Rashmi Khanal, M.D. | Name | Tarah Satterfield, MPH | Name | Boyu Hu, MD |
| [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | ||||||||||||||||||||
| Phone | 205-966-8400 | Phone | 520-694-2873 | Phone | 714-456-3476 | Phone | 858-246-0682 | Phone | 352-294-8938 | Phone | 404-851-8523 | Phone | 312-226-2371 | Phone | 319-353-6347 | Phone | 316-613-4300 | Phone | 316-613-4313 | Phone | 502-899-3366 | Phone | 313-576-8030 | Phone | 516-734-8973 | Phone | 646-962-7950 | Phone | 503-494-1080 | Phone | 215-955-5769 | Phone | 215-728-4300 | Phone | 214-820-6967 | Phone | 801-585-0255 |
Facility Investigators
| Sequence: | 18390085 | Sequence: | 18390086 | Sequence: | 18390087 | Sequence: | 18390088 | Sequence: | 18390089 | Sequence: | 18390090 | Sequence: | 18390091 | Sequence: | 18390092 | Sequence: | 18390093 | Sequence: | 18390094 | Sequence: | 18390095 | Sequence: | 18390096 | Sequence: | 18390097 | Sequence: | 18390098 | Sequence: | 18390099 | Sequence: | 18390100 | Sequence: | 18390101 |
| Facility Id | 200702462 | Facility Id | 200702463 | Facility Id | 200702464 | Facility Id | 200702465 | Facility Id | 200702466 | Facility Id | 200702467 | Facility Id | 200702468 | Facility Id | 200702469 | Facility Id | 200702470 | Facility Id | 200702471 | Facility Id | 200702472 | Facility Id | 200702473 | Facility Id | 200702474 | Facility Id | 200702475 | Facility Id | 200702476 | Facility Id | 200702477 | Facility Id | 200702478 |
| Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator |
| Name | Abhijeet Kumar, MD | Name | Lauren C. Pinter-Brown, MD | Name | Ayad Hamdan, M.D. | Name | Erin Dean, MD | Name | Lawrence E Morris, Jr, MD | Name | Sunita Nathan, MD | Name | Umar Farooq, MD | Name | Bassam I. Mattar, MD | Name | Joseph Maly, M.D. | Name | Dipenkumar Modi, MD | Name | Ruthee-Lu Bayer, MD | Name | Tsiporah Shore, MD | Name | Jennifer Saultz, D.O. | Name | Usama Gergis, MD | Name | Rashmi Khanal, M.D. | Name | Houston Holmes, MD | Name | Boyu Hu, MD |
Browse Interventions
| Sequence: | 96335538 | Sequence: | 96335539 | Sequence: | 96335540 | Sequence: | 96335541 | Sequence: | 96335542 | Sequence: | 96335543 | Sequence: | 96335544 | Sequence: | 96335545 | Sequence: | 96335546 | Sequence: | 96335547 | Sequence: | 96335548 | Sequence: | 96335549 | Sequence: | 96335550 | Sequence: | 96335551 | Sequence: | 96335552 | Sequence: | 96335553 | Sequence: | 96335554 | Sequence: | 96335555 | Sequence: | 96335556 |
| Mesh Term | Cyclophosphamide | Mesh Term | Bendamustine Hydrochloride | Mesh Term | Rituximab | Mesh Term | Fludarabine | Mesh Term | Interleukin-2 | Mesh Term | Immunosuppressive Agents | Mesh Term | Immunologic Factors | Mesh Term | Physiological Effects of Drugs | Mesh Term | Antirheumatic Agents | Mesh Term | Antineoplastic Agents, Alkylating | Mesh Term | Alkylating Agents | Mesh Term | Molecular Mechanisms of Pharmacological Action | Mesh Term | Antineoplastic Agents | Mesh Term | Myeloablative Agonists | Mesh Term | Antineoplastic Agents, Immunological | Mesh Term | Analgesics, Non-Narcotic | Mesh Term | Analgesics | Mesh Term | Sensory System Agents | Mesh Term | Peripheral Nervous System Agents |
| Downcase Mesh Term | cyclophosphamide | Downcase Mesh Term | bendamustine hydrochloride | Downcase Mesh Term | rituximab | Downcase Mesh Term | fludarabine | Downcase Mesh Term | interleukin-2 | Downcase Mesh Term | immunosuppressive agents | Downcase Mesh Term | immunologic factors | Downcase Mesh Term | physiological effects of drugs | Downcase Mesh Term | antirheumatic agents | Downcase Mesh Term | antineoplastic agents, alkylating | Downcase Mesh Term | alkylating agents | Downcase Mesh Term | molecular mechanisms of pharmacological action | Downcase Mesh Term | antineoplastic agents | Downcase Mesh Term | myeloablative agonists | Downcase Mesh Term | antineoplastic agents, immunological | Downcase Mesh Term | analgesics, non-narcotic | Downcase Mesh Term | analgesics | Downcase Mesh Term | sensory system agents | Downcase Mesh Term | peripheral nervous system agents |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Conditions
| Sequence: | 52351479 |
| Name | Non Hodgkin Lymphoma |
| Downcase Name | non hodgkin lymphoma |
Id Information
| Sequence: | 40287808 |
| Id Source | org_study_id |
| Id Value | AB-101-01 |
Countries
| Sequence: | 42709706 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55794348 | Sequence: | 55794349 |
| Group Type | Experimental | Group Type | Experimental |
| Title | Phase 1: Dose confirmation of AB-101 as mono, ritux combo (including DLBCL specific) & BR combo | Title | Phase 2: AB-101 given with rituximab or with BR to patients with B-cell NHL at the R2PD |
| Description | 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 | Description | Phase 2: AB-101 given with rituximab or with bendamustine and rituximab to patients with B-cell NHL at the R2PD |
Interventions
| Sequence: | 52662722 | Sequence: | 52662723 | Sequence: | 52662724 | Sequence: | 52662725 | Sequence: | 52662726 | Sequence: | 52662727 |
| Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug | Intervention Type | Drug |
| Name | AB-101 | Name | Rituximab | Name | Interleukin-2 | Name | Cyclophosphamide | Name | Fludarabine | Name | Bendamustine |
| Description | NK cell therapy | Description | Anti-CD20 antibody therapy | Description | Immune cytokine | Description | Lymphodepleting chemotherapy | Description | Lymphodepleting chemotherapy | Description | Chemoimmunotherapy |
Keywords
| Sequence: | 80117697 | Sequence: | 80117695 | Sequence: | 80117696 | Sequence: | 80117698 | Sequence: | 80117699 | Sequence: | 80117700 |
| Name | cell therapy | Name | lymphoma | Name | NHL | Name | rituximab | Name | NK cell | Name | bendamustine |
| Downcase Name | cell therapy | Downcase Name | lymphoma | Downcase Name | nhl | Downcase Name | rituximab | Downcase Name | nk cell | Downcase Name | bendamustine |
Design Outcomes
| Sequence: | 178045826 | Sequence: | 178045825 | Sequence: | 178045827 | Sequence: | 178045828 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
| Measure | Phase 1, combination therapy: AB-101 clinical activity, determined by ORR | Measure | Phase 1, monotherapy: Safety and tolerability of AB-101 as monotherapy, in combination with rituximab (including the DLBCL specific cohort) and in combination with bendamustine and rituximab, based on adverse events (AEs) | Measure | Phase 1, combination therapy: Identify the recommended Phase 2 dose (R2PD) for AB-101. | Measure | 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. | Time Frame | From the ICF signature through 13 weeks after last study drug dose. | Time Frame | From ICF signature through 13 weeks after last study drug dose. | Time Frame | From baseline disease assessment through end of study participation. |
| Description | 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. | Description | Incidence, severity, and dose relationship of AEs and serious AEs (SAEs) | Description | R2PD will be determined based on safety and tolerability of AB-101 in combination with rituximab or in combination with bendamustine and rituximab. | Description | The efficacy profile will be determined by the ORR. |
Browse Conditions
| Sequence: | 194173748 | Sequence: | 194173749 | Sequence: | 194173750 | Sequence: | 194173751 | Sequence: | 194173752 | Sequence: | 194173753 | Sequence: | 194173754 | Sequence: | 194173755 |
| Mesh Term | Lymphoma | Mesh Term | Lymphoma, Non-Hodgkin | Mesh Term | Neoplasms by Histologic Type | Mesh Term | Neoplasms | Mesh Term | Lymphoproliferative Disorders | Mesh Term | Lymphatic Diseases | Mesh Term | Immunoproliferative Disorders | Mesh Term | Immune System Diseases |
| Downcase Mesh Term | lymphoma | Downcase Mesh Term | lymphoma, non-hodgkin | Downcase Mesh Term | neoplasms by histologic type | Downcase Mesh Term | neoplasms | Downcase Mesh Term | lymphoproliferative disorders | Downcase Mesh Term | lymphatic diseases | Downcase Mesh Term | immunoproliferative disorders | Downcase Mesh Term | immune system diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48487609 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | Artiva Biotherapeutics, Inc. |
Overall Officials
| Sequence: | 29381054 |
| Role | Study Director |
| Name | Thorsten Graef, M.D., Ph.D. |
| Affiliation | Artiva Biotherapeutics |
Central Contacts
| Sequence: | 12054518 |
| Contact Type | primary |
| Name | AB-101-01 Trial Operations |
| Phone | 858-267-4491 |
| [email protected] | |
| Role | Contact |
Design Group Interventions
| Sequence: | 68394803 | Sequence: | 68394804 | Sequence: | 68394805 | Sequence: | 68394806 | Sequence: | 68394807 | Sequence: | 68394808 | Sequence: | 68394809 | Sequence: | 68394810 | Sequence: | 68394811 | Sequence: | 68394812 | Sequence: | 68394813 | Sequence: | 68394814 |
| Design Group Id | 55794348 | Design Group Id | 55794349 | Design Group Id | 55794348 | Design Group Id | 55794349 | Design Group Id | 55794348 | Design Group Id | 55794349 | Design Group Id | 55794348 | Design Group Id | 55794349 | Design Group Id | 55794348 | Design Group Id | 55794349 | Design Group Id | 55794348 | Design Group Id | 55794349 |
| Intervention Id | 52662722 | Intervention Id | 52662722 | Intervention Id | 52662723 | Intervention Id | 52662723 | Intervention Id | 52662724 | Intervention Id | 52662724 | Intervention Id | 52662725 | Intervention Id | 52662725 | Intervention Id | 52662726 | Intervention Id | 52662726 | Intervention Id | 52662727 | Intervention Id | 52662727 |
Eligibilities
| Sequence: | 30869747 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | No |
| Criteria | Inclusion Criteria: Confirmed diagnosis of 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. 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. |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254024972 |
| Number Of Facilities | 18 |
| Registered In Calendar Year | 2020 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | False |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 4 |
Designs
| Sequence: | 30615552 |
| Allocation | Non-Randomized |
| Intervention Model | Sequential Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | None (Open Label) |
Responsible Parties
| Sequence: | 28982083 |
| Responsible Party Type | Sponsor |