Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Clinical Trial
— ZUMA-7Official title:
A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)
| Verified date | February 2024 |
| Source | Gilead Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
| Status | Active, not recruiting |
| Enrollment | 359 |
| Est. completion date | October 2024 |
| Est. primary completion date | March 18, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Key Inclusion Criteria: - Histologically proven large B-cell lymphoma including the following types defined by World Health Organization (WHO) 2016. - Diffuse large B-cell lymphoma (DLBCL) not otherwise specified activated B-cell/ germinal center B-cell (ABC/GCB). - High-grade B-cell lymphoma (HGBL) with or without myelocytomatosis oncogene (MYC) and B-cell lymphoma (BCL) 2 and/or BCL6 rearrangement. - DLBCL arising from follicular lymphoma (FL). - T-cell/histiocyte rich large B-cell lymphoma. - DLBCL associated with chronic inflammation. - Primary cutaneous DLBCL, leg type. - Epstein-Barr virus (EBV) + DLBCL. - Relapsed or refractory disease after first-line chemoimmunotherapy. - Refractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded. - Progressive disease (PD) as best response to first-line therapy. - Stable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP). - Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression = 12 months of therapy. - Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse = 12 months of first-line therapy. - Individuals must have received adequate first-line therapy including at a minimum: - Anti-Cluster of Differentiation antigen (CD) 20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and - An anthracycline containing chemotherapy regimen. - No known history or suspicion of central nervous system involvement by lymphoma. - Eastern cooperative oncology group (ECOG) performance status of 0 or 1. - Adequate bone marrow function as evidenced by: - Absolute neutrophil count (ANC) = 1000/uL - Platelet = 75,000/uL - Absolute lymphocyte count = 100/uL - Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by: - Creatinine clearance (Cockcroft Gault) = 60 mL/min. - Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) = 2.5 Upper limit of normal (ULN). - Total bilirubin = 1.5 mg/dl - Cardiac ejection fraction = 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings. - No clinically significant pleural effusion. - Baseline oxygen saturation > 92% on room air. Key Exclusion Criteria: - History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years. - Received more than one line of therapy for DLBCL. - History of autologous or allogeneic stem cell transplant. - Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management. - Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing. - Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases. - History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement. - Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted. - History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment. - History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment. - History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years. - History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7. Note: Other protocol defined Inclusion/Exclusion criteria may apply |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Peter MacCallum Cancer Center | Melbourne | Victoria |
| Austria | Universitatsklinikum Graz, Division of Hematology | Graz | |
| Austria | Medizinische Universitat Innsbruck, Innere Medizin V - Hamatologie und Onkologie | Innsbruck | |
| Belgium | Cliniques Universiaires Saint-Luc | Brussels | |
| Belgium | UZ Gasthuisberg | Leuven | |
| Canada | QEII Health Sciences Centre | Halifax | |
| Canada | McGill University Health Center | Montreal | Quebec |
| Canada | Centre Integre Universitaire de Sante et Services Sociaux de l'Est-de-l'lle-de-Montreal / Hopital Maisonneuve-Rosemont | Montréal | |
| Canada | The Ottawa Hospital - General Campus | Ottawa | |
| Canada | CHU de Quebec-Universite Laval, Hopital de L'Enfante-Jesus | Québec | |
| Canada | Uninversity Health Network - Princess Margaret Cancer Center | Toronto | Ontario |
| Canada | Vancouver General Hospital | Vancouver | British Columbia |
| Canada | CancerCare Manitoba | Winnipeg | Manitoba |
| France | CHRU de Lille - Hopital Claude Huriez | Lille cedex | |
| France | Hopital Saint-Louis | Paris | |
| France | Centre Hospitalier Lyon-Sud - Service d'Hematologie clinique | Pierre Benite | |
| France | Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou | Rennes | |
| Germany | Universitäts-klinikum Dresden | Dresden | |
| Germany | Universitatsmedizin Gottingen | Göttingen | |
| Germany | Universitatsklinikum Hamburg-Eppendorf | Hamburg | |
| Germany | Universitätsklinikum Heidelberg | Heidelberg | |
| Germany | Universitäts-klinikum Würzburg | Würzburg | |
| Israel | Tel Aviv Sourasky Medical Center | Tel Aviv | |
| Italy | Instituto di Ematologia "L. e A. Seragnoli" - Dipartimento di Medicina Specialistica Diagnostica e Sperimentale | Bologna | |
| Italy | IRCCS Ospedale San Raffaele di Milano | Milano | |
| Netherlands | Academic Medical Center | Amsterdam | |
| Netherlands | University Medical Center Groningen | Groningen | |
| Netherlands | Erasmus Medical Center | Rotterdam | |
| Netherlands | University Medical Center Utrecht | Utrecht | |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Institut Catala d'Oncologia | Barcelona | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Clinica Universidad de Navarra | Pamplona | |
| Spain | Hospital Universitario de Salamanca | Salamanca | |
| Sweden | Uppsala Akademiska Sjukhus | Uppsala | |
| Switzerland | IOSI, OSpedale Regionale Bellinzona e Valli | Bellinzona | |
| Switzerland | University Hospital Zurich | Zürich | |
| United Kingdom | University Hospitals Birmingham NHS Foundation Trust | Birmingham | |
| United Kingdom | Barts Health NHS Trust | London | |
| United Kingdom | University College London Hospitals NHS Foundation Trust | London | |
| United Kingdom | The Christie NHS Foundation Trust | Manchester | |
| United Kingdom | The Royal Marsden NHS Foundation Trust | Sutton | |
| United States | University of Maryland, Greenbaum Comprehensive Cancer Center | Baltimore | Maryland |
| United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
| United States | University of Virginia Health System | Charlottesville | Virginia |
| United States | Northwestern University | Chicago | Illinois |
| United States | University of Chicago Medical Center | Chicago | Illinois |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
| United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
| United States | Banner MD Anderson Cancer Center | Gilbert | Arizona |
| United States | John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey |
| United States | The University of Texas, MD Anderson Cancer Center | Houston | Texas |
| United States | University of Iowa Hospitals and Clinincs | Iowa City | Iowa |
| United States | The University of Kansas Cancer Center | Kansas City | Kansas |
| United States | UC San Diego Moores Cancer Center | La Jolla | California |
| United States | University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center | Miami | Florida |
| United States | Henry-Joyce Cancer Center | Nashville | Tennessee |
| United States | Sarah Cannon Research Institute | Nashville | Tennessee |
| United States | Icahn School of Medicine at Mount Sinai | New York | New York |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | Mayo Clinic Hospital | Phoenix | Arizona |
| United States | UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania |
| United States | Mayo Clinic, Patient Location | Rochester | Minnesota |
| United States | University of Rochester Medical Center | Rochester | New York |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | University of Utah, Huntsman Cancer Institute | Salt Lake City | Utah |
| United States | UCLA | Santa Monica | California |
| United States | Swedish Cancer Institute | Seattle | Washington |
| United States | Stanford Cancer Institute | Stanford | California |
| United States | Moffitt Cancer Center | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Kite, A Gilead Company |
United States, Australia, Austria, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom,
Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800. — View Citation
Elsawy M, Chavez JC, Avivi I, Larouche JF, Wannesson L, Cwynarski K, Osman K, Davison K, Rudzki JD, Dahiya S, Dorritie K, Jaglowski S, Radford J, Morschhauser F, Cunningham D, Martin Garcia-Sancho A, Tzachanis D, Ulrickson ML, Karmali R, Kekre N, Thieblemont C, Enblad G, Dreger P, Malladi R, Joshi N, Wang WJ, Solem CT, Snider JT, Cheng P, To C, Kersten MJ. Patient-reported outcomes in ZUMA-7, a phase 3 study of axicabtagene ciloleucel in second-line large B-cell lymphoma. Blood. 2022 Nov 24;140(21):2248-2260. doi: 10.1182/blood.2022015478. — View Citation
Filosto S, Vardhanabhuti S, Canales M, Poiré X, Lekakis LJ, de Vos S, et al. Product attributes of axicabtagene ciloleucel (axi-cel) that associate differentially with efficacy and toxicity in second-line large B-cell lymphoma. Cancer Res. 2022;82(12_Supplement):CT004.
Ghobadi A, Munoz J, Westin J, Locke FL, Miklos DB, Rapoport AP, et al. Outcomes of Subsequent Anti-Lymphoma Therapies in Patients (Pts) with Large B-Cell Lymphoma (LBCL) Treated with Axicabtagene Ciloleucel (Axi-Cel) or Standard of Care (SOC) in the Second-Line (2L) ZUMA-7 Study. Blood. 2022;140(Supplement 1):1595-1597.
Kersten MJ, Qiao Y, Shah R, Solem C, Snider JT, To C, Cheng P, Spooner C, Perales MA. Quality-Adjusted Time without Symptoms or Toxicity: Analysis of Axicabtagene Ciloleucel versus Standard of Care in Patients with Relapsed/Refractory Large B Cell Lymphoma. Transplant Cell Ther. 2023 May;29(5):335.e1-335.e8. doi: 10.1016/j.jtct.2023.01.008. Epub 2023 Jan 14. — View Citation
Locke FL, Miklos DB, Jacobson CA, Perales MA, Kersten MJ, Oluwole OO, Ghobadi A, Rapoport AP, McGuirk J, Pagel JM, Munoz J, Farooq U, van Meerten T, Reagan PM, Sureda A, Flinn IW, Vandenberghe P, Song KW, Dickinson M, Minnema MC, Riedell PA, Leslie LA, Chaganti S, Yang Y, Filosto S, Shah J, Schupp M, To C, Cheng P, Gordon LI, Westin JR; All ZUMA-7 Investigators and Contributing Kite Members. Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma. N Engl J Med. 2022 Feb 17;386(7):640-654. doi: 10.1056/NEJMoa2116133. Epub 2021 Dec 11. — View Citation
Locke FL, Oluwole OO, Kuruvilla J, Thieblemont C, Morschhauser F, Salles G, et al. Association of Metabolic Tumor Volume (MTV) and Clinical Outcomes in Second-Line (2L) Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) Following Axicabtagene Ciloleucel (Axi-Cel) Versus Standard-of-Care (SOC) Therapy in ZUMA-7. Blood. 2022;140(Supplement 1):638-640.
Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, Advani R, Ghielmini M, Salles GA, Zelenetz AD, Jaffe ES. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016 May 19;127(20):2375-90. doi: 10.1182/blood-2016-01-643569. Epub 2016 Mar 15. — View Citation
Westin JR, Locke FL, Dickinson M, Ghobadi A, Elsawy M, van Meerten T, Miklos DB, Ulrickson ML, Perales MA, Farooq U, Wannesson L, Leslie L, Kersten MJ, Jacobson CA, Pagel JM, Wulf G, Johnston P, Rapoport AP, Du L, Vardhanabhuti S, Filosto S, Shah J, Snider JT, Cheng P, To C, Oluwole OO, Sureda A. Safety and Efficacy of Axicabtagene Ciloleucel versus Standard of Care in Patients 65 Years of Age or Older with Relapsed/Refractory Large B-Cell Lymphoma. Clin Cancer Res. 2023 May 15;29(10):1894-1905. doi: 10.1158/1078-0432.CCR-22-3136. — View Citation
Westin JR, Oluwole OO, Kersten MJ, Miklos DB, Perales MA, Ghobadi A, Rapoport AP, Sureda A, Jacobson CA, Farooq U, van Meerten T, Ulrickson M, Elsawy M, Leslie LA, Chaganti S, Dickinson M, Dorritie K, Reagan PM, McGuirk J, Song KW, Riedell PA, Minnema MC, Yang Y, Vardhanabhuti S, Filosto S, Cheng P, Shahani SA, Schupp M, To C, Locke FL; ZUMA-7 Investigators; Kite Members. Survival with Axicabtagene Ciloleucel in Large B-Cell Lymphoma. N Engl J Med. 2023 Jul 13;389(2):148-157. doi: 10.1056/NEJMoa2301665. Epub 2023 Jun 5. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Event Free Survival (EFS) Per Blinded Central Assessment | EFS:Time from randomization to disease progression (PD), best response of SD up to and including Day 150, commencement of subsequent new anti-lymphoma therapy including stem cell transplant, or death from any cause. PD=score 4 (uptake moderately>liver)/5 (uptake markedly >liver and/or new lesions) with an increase in intensity of uptake from baseline;new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/EOT assessment, rather than another etiology or in bone marrow;an individual node/lesion must be abnormal with LDi >1.5 cm, increase by =50% from cross-product of LDi and perpendicular diameter nadir, increase in LDi or shortest axis perpendicular to LDi from nadir, splenic length must increase by >50% of extent of its prior increase beyond Baseline. If no prior splenomegaly, increase must be =2 cm from baseline;new/recurrent splenomegaly;new/clear progression of pre-existing NMLs;new lesion;new/recurrent bone marrow involvement. KM estimates was used for analysis. | From randomization date up to a median follow-up: 24.9 months | |
| Secondary | Objective Response Rate (ORR) Per Blinded Central Assessment | ORR: Percentage of participants with CR [CMR;CRR] or PR [partial metabolic response (PMR); partial radiologic response (PRR)].CMR: PET 5PS scores of 1 (no uptake above background, 2(uptake=mediastinum), 3(uptake>mediastinum but=liver) with/without a residual mass;no new lesions; no evidence of FDG-avid disease in BM. CRR:target nodes/nodal masses regressed to = 1.5 cm in LDi;no extralymphatic sites of disease;absent non-measured lesions (NMLs);organ enlargement regress to normal;no new sites;bone marrow morphology normal. PMR:scores 4 (uptake moderately>liver),5(uptake markedly > liver, new lesions) with reduced uptake compared with baseline and residual mass;no new lesions;responding disease at interim/residual disease at end of treatment (EOT).PRR: =50% decrease in sum of the product of perpendicular diameters (SPD) of up to 6 target measurable nodes and extra-nodal sites;absent/normal, regressed, but no increase of NMLs;spleen regressed by >50% in length beyond normal;no new sites. | From randomization date up to a median follow-up: 24.9 months | |
| Secondary | Overall Survival (OS) | Overall survival is defined as the time from randomization to death from any cause. Kaplan-Meier (KM) estimates was used for analysis. | From randomization date up to a median follow-up: 47.2 months | |
| Secondary | Duration of Response (DOR) Per Blinded Central Assessments | DOR is defined only for participants who experience an objective response after axicabtagene ciloleucel infusion and is the time from the first objective response per Lugano classification to disease progression or death from any cause. Objective response is defined in outcome measure 2 and disease progression is defined in outcome measure 1. KM estimates were used for analysis. | From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (Up to 37.8 months) | |
| Secondary | Modified Event Free Survival (mEFS) Per Blinded Central Assessment | Modified event free survival is defined the same way as EFS, except that a best response of SD up to and including Day 150 assessment post randomization was not considered an event. KM estimates were used for analysis. | From randomization date up to a median follow-up: 24.9 months | |
| Secondary | Event Free Survival Per Investigator Disease Assessments | EFS was defined as the time from randomization to the earliest date of disease progression per the IWG Lugano Classification, best response of stable disease (SD) up to and including Day 150, commencement of new lymphoma therapy, or death from any cause. Disease progression is defined in outcome measure 1. | From randomization date up to a median follow-up: 47.2 months | |
| Secondary | Progression-Free Survival (PFS) Per Investigator Disease Assessments | PFS is defined as the time from the randomization date to the date of disease progression per Lugano classification or death from any cause. Disease progression is defined in outcome measure 1. KM estimates was used for analysis. | From randomization date up to a median follow-up: 47.2 months | |
| Secondary | Modified Event Free Survival (mEFS) Per Investigator Assessment | Modified event free survival is defined the same way as EFS, except that a best response of SD up to and including Day 150 assessment post randomization was not considered an event. KM estimates were used for analysis. | From randomization date up to a median follow-up: 47.2 months | |
| Secondary | Change From Baseline in Global Health Status Scores | Global health status was measured using European Organization for Research and Treatment of Cancer (EORTC) Quality Life Questionnaire (QLQ) C-30. This health related quality of life (HRQoL) questionnaire was comprised of 15 questions on functional scales, 13 questions on symptom scales and 2 on global health status scale. Global Health Status used a 7 point Likert-type scale of 1 (Very poor) to 7 (Excellent). All scores were transformed to 0-100. Higher scores for Global Health Status indicated better HRQoL. | Baseline, Days 50, 100, and 150; Months 9, 12, 15, 18, 21 and 24 | |
| Secondary | Change From Baseline in EORTC QLQ-C30 Physical Functioning Score | The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).
The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were transformed to a scale from 0 to 100, where a high score indicated better QoL. A positive change from baseline indicates better QoL. |
Baseline, Days 50, 100, 150, Months 9, 12, 15, 18, 21 and 24 | |
| Secondary | Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale (EQ-5D-5L) Index Score | The Euro-QOL, Five Dimensions, Five Levels (EQ-5D-5L) questionnaire is a generic measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L comprises 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health states using a visual analog scale (VAS). The total score for EQ-5D-5L index- is presented on a range from 0 to 1 where higher scores indicate better outcome. A positive change from Baseline indicates improvement. | Baseline, Days 50, 100, 150; Months 9, 12, 15, 18, 21 and 24 | |
| Secondary | Change From Baseline in EQ-5D-5L VAS Scale Score | The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the participants' health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each participant for his or her current HRQoL state and scored 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"). The value 100 indicates improvement. | Baseline, Days 50, 100, 150; Months 9, 12, 18, 21 and 24 | |
| Secondary | Number of Participants With Anti-Axicabtagene Ciloleucel Antibodies | From first dose of axicabtagene up to a median follow-up: 24 months | ||
| Secondary | Percentage of Participants Experiencing Treatment-emergent Adverse Events | A TEAE is defined as any AE that begins on or after the first dose of study treatment (axicabtagene ciloleucel infusion or SOC), excluding bridging therapy. Participant incidence rates of TEAEs, including all, serious, fatal, CTCAE Grade 3 or higher, and treatment related AEs reported will be tabulated by preferred term and system organ class coded with the Medical Dictionary for Regulatory Activities (MedDRA). | Up to 5 years | |
| Secondary | Percentage of Participants With Clinically Significant Changes in Laboratory Values Reported as Grade 3 or Higher TEAEs | Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. | Up to 5 years |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03992339 -
A Study of Evaluating the Safety and Efficacy of ATG-010 in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
|
Phase 2 |