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CELL THERAPY

Hematological malignancies
1L high-risk LBCL
ZUMA-23
Adaptive Phase 3, randomized, open-label, multicenter study to compare the efficacy and safety of axicabtagene ciloleucel versus standard of care therapy as first-line therapy in patients with high-risk LBCL
NCT05605899
R/R DLBCL
KITE-197a
Phase 1 open-label, single arm, multicenter study evaluating the safety and efficacy of KITE-197 in patients with R/R DLBCL
NCT06079164
The safety and efficacy of these investigational agents have not been established, and they have not received marketing authorization in this setting. There is no guarantee that these investigational agents and/or uses will receive Health Authority approval and/or become commercially available.
R/R DLBCL
KITE-363 OR KITE-753a
Phase 1 open-label, multicenter study evaluating the safety and efficacy of KITE-363 or KITE-753, autologous antiCD19/20 CAR-T cell therapies, in patients with R/R DLBCL
NCT04989803
2L+ high-risk FL ZUMA-22
Phase 3 randomized, open-label, multicenter study evaluating the efficacy of axicabtagene ciloleucel versus standard of care therapy in patients with R/R FL
NCT05371093 R/R MM
Phase 2 open label, multicenter, study of antiocabtagene autoleucel for the treatment of patients with R/R MM
NCT05396885 R/R MM iMMagine-3b
Phase 3, randomized, open-label study to compare the efficacy and safety of anitocabtagene autoleucel versus standard of care therapy in patients with R/R MM
NCT06413498
CELL THERAPY

Solid tumors
GBM
EGFR IL13Ra2 CAR-Tc
A Phase 1, Open-label Study Evaluating the Safety and Feasibility of CAR-T-EGFR-IL13Ra2 Cells in Patients With EGFR-Amplified Recurrent GBM
NCT05168423
R/R Neuroblastoma
GPC2 CAR-Td
A Phase 1 Trial of GPC2-Directed Chimeric Antigen Receptor Autologous T Cells (GPC2 CAR-T) for Relapsed or Refractory Neuroblastoma
NCT05650749
The safety and efficacy of these investigational agents have not been established, and they have not received marketing authorization in this setting. There is no guarantee that these investigational agents and/or uses will receive Health Authority approval and/or become commercially available.
BREAST

Adjuvant TNBC
ASCENT-05e
Phase 3 randomized, open-label study of adjuvant sacituzumab govitecan and pembrolizumab versus treatment of physician’s choice in patients with TNBC who have residual invasive disease after surgery and neoadjuvant therapy
NCT05633654
THORACIC

1L mNSCLC, PD-L1 TPS ≥50% EVOKE-03f
Phase 3 randomized, open-label, multicenter, activecomparator-controlled clinical study of pembrolizumab in combination with sacituzumab govitecan versus pembrolizumab monotherapy as first-line treatment in patients with PD-L1 TPS ≥50% mNSCLC
NCT05609968
1L/2L+ mNSCLC
EDGE-Lungg
Phase 2, open-label, platform study, to evaluate immunotherapy-based combinations in patients with advanced NSCLC
NCT05676931

The safety and efficacy of these investigational agents have not been established, and they have not received marketing authorization in this setting. There is no guarantee that these investigational agents and/or uses will receive Health Authority approval and/or become commercially available.
Stage 2-3 resectable NSCLC
1-2L mNSCLC
VELOCITY-Lungg
Phase 2 platform study evaluating the safety and efficacy of novel treatment combinations in patients with lung cancer
NCT05633667

GU/GI/GYN

1L/2L+ mUC TROPHY U-01 (multicohort)
Phase 2, open-label study of sacituzumab govitecan in patients with unresectable locally advanced/metastatic urothelial cancer
NCT03547973
2L+ mEC
ASCENT-GYN-01h
Phase 3 randomized, open-label study of sacituzumab govitecan versus treatment of physician’s choice in patients with endometrial cancer who have received prior platinumbased chemotherapy and PD-(L)1 immunotherapy
NCT06486441
The safety and efficacy of these investigational agents have not been established, and they have not received marketing authorization in this setting. There is no guarantee that these investigational agents and/or uses will receive Health Authority approval and/or become commercially available.
1-2L mPDAC
ARC-8g
Phase 1, open-label study to evaluate the safety and tolerability of quemliclustat in combination with zimberelimab, nab-paclitaxel and gemcitabine in patients with advanced pancreatic cancer
NCT04104672
Solid tumors
EVER-132-003i

Phase 2 open-label study of sacituzumab govitecan in patients with solid tumors
NCT05119907
CLINICAL TRIAL BOOKLETS
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aManufacturing Innovation.
bIn collaboration with Arcellx, Inc.
cIn collaboration with University of Pennsylvania.
dIn collaboration with Children’s Hospital of Philadelphia.
eIn collaboration with Alliance Foundation Trials, LLC and the National Surgical Adjuvant Breast and Bowel Project Foundation, Inc.
fIn collaboration with Merck.
gIn collaboration with Arcus Biosciences.
hIn collaboration with the Gynecologic Oncology Group (GOG) Foundation and the European Network of Gynaecological Oncological Trial Groups (ENGOT).
iOnly cervical cancer cohort is enrolling at this time.
1L, first line; 2L, second line; CAR, chimeric antigen receptor; CD19/20, cluster of differentiation 19/20; DLBCL, diffuse large B-cell lymphoma; EC, endometrial cancer; EGFR, epidermal growth factor receptor; FL, follicular lymphoma; GBM, glioblastoma; GPC2, glypican 2; GI, gastrointestinal; GU, genitourinary; GYN, gynecological; IL13Ra2, interleukin-13 receptor subunit alpha 2; LBCL, large B-cell lymphoma; m, metastatic; MM, multiple myeloma; NCT, national clinical trial; NSCLC, non-small cell lung cancer; PDAC, pancreatic ductal adenocarcinoma; PD-(L)1, programmed cell death (ligand) 1; R/R, relapsed/refractory; TNBC, triple-negative breast cancer; TPS, tumor proportion score; UC, urothelial cancer.

GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc. KITE and the KITE logo are trademarks of Kite Pharma, Inc. All other trademarks referenced herein are the property of their respective owners. © 2025 Gilead Sciences, Inc. All rights reserved. IHQ-UNB-0000 March 2025