Cell therapy program

Cell therapy pipeline Gilead and Kite pipeline Clinical trials now enrolling Technology behind our science

Our approach to blood cancers

Cell therapy is a unique therapeutic platform where a patient’s own cells are the starting point to create the treatment. Cell therapy modifies a patient’s own immune cells to target their cancer.

Cell therapy pipeline

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population clinical trials research area molecules target

DLBCL
ZUMA-23
ZUMA-23 Ph 3

ZUMA-23

An 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 Subjects with High-Risk Large B-Cell Lymphoma

Click row to view on clinicaltrials.gov

CD19 1L high-risk LBCL
axicabtagene ciloleucel axi-cel CD19
ZUMA-24
ZUMA-24 Ph 2

ZUMA-24

A Phase 2 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel Concomitant With Prophylactic Steroids in Subjects With Relapsed or Refractory Large B-Cell Lymphoma in the Outpatient Setting

Click row to view on clinicaltrials.gov

CD19 2L LBCL outpatient
axicabtagene ciloleucel axi-cel CD19
KT-US-656-0601a
KT-US-656-0601a Ph 1

KT-US-656-0601 (KTE-197)

A Phase 1 Open-label, Single Arm, Multicenter Study Evaluating the Safety and Efficacy of KITE-197 in Subjects With Relapsed or Refractory Large B-cell Lymphoma

Click row to view on clinicaltrials.gov

Next-gen CD19 CAR-T R/R DLBCL
KITE-197 Next-gen CD19 CAR-T
KT-US-499-0150a
KT-US-499-0150a Ph 1

KT-US-499-0150 (KTE-363)

A Phase 1 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy, in Subjects With Relapsed and/or Refractory B-cell Lymphoma

Click row to view on clinicaltrials.gov

CD19/20 bicistronic R/R DLBCL
KITE-363 CD19/20 bicistronic
KT-US-499-0150a
KT-US-499-0150a Ph 1

KT-US-499-0150 (KTE-753)

A Phase 1 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy, in Subjects With Relapsed and/or Refractory B-cell Lymphoma

Click row to view on clinicaltrials.gov

CD19/20 bicistronic R/R DLBCL
KITE-753 CD19/20 bicistronic

FL
ZUMA-22
ZUMA-22 Ph 3

ZUMA-22

A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Follicular Lymphoma

Click row to view on clinicaltrials.gov

CD19 2L+ high-risk FL
axicabtagene ciloleucel axi-cel CD19

ALL/NHL
ZUMA-4
ZUMA-4 Ph 1/2

ZUMA-4

A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

Click row to view on clinicaltrials.gov

CD19 R/R Pediatric ALL/NHL
brexucabtagene autoleucel brexu-cel CD19

MM
iMMagine-3b
iMMagine-3b Ph 3

iMMagine-3

A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma

Click row to view on clinicaltrials.gov

BCMA R/R MM
anitocabtagene autoleucel anito-cel BCMA
iMMagine-1b
iMMagine-1b Ph 2

iMMagine-1

A Phase 2, Multicenter Study Evaluating the Safety and Efficacy of Anitocabtagene Autoleucel (CART-ddBCMA) in Participants with Relapsed or Refractory Multiple Myelomaa

Click row to view on clinicaltrials.gov

BCMA R/R MM
anitocabtagene autoleucel anito-cel BCMA
Phase 1b
Phase 1b Ph 1

Phase 1

Master Protocol for the Phase 1 Study of Cell Therapies for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, Including Long-term Safety Follow-up

Click row to view on clinicaltrials.gov

BCMA R/R MM
anitocabtagene autoleucel anito-cel BCMA

The safety and efficacy of these investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.

aManufacturing Innovation. bIn collaboration with Arcellx, Inc.
1L, first line; 2L, second line; ALL, acute lymphoblastic leukemia; BCMA, B cell maturation antigen; CAR-T, chimeric antigen receptor T-cell; CD19/20, cluster of differentiation 19/20; DLBCL, diffuse large B-cell lymphoma; FL, follicular lymphoma; LBCL, large B-cell lymphoma; MM, multiple myeloma; NHL, non-Hodgkin lymphoma; Ph, phase; R/R, relapsed/refractory.

Our scientific focus areas target:
Tumor-intrinsic cell death Immune-mediated tumor killing Tumor-permissive microenvironment
TUMOR TYPE RESEARCH AREA Molecule(s)
PHASE 1 PHASE 2 PHASE 3
Hematological malignancies 1L high-risk LBCL (ZUMA-23) Axicabtagene ciloleucel NCT05605899
2L LBCL outpatient (ZUMA-24) Axicabtagene ciloleucel NCT05459571
R/R DLBCL KITE-197 (next-gen CD19 CART) NCT06079164
R/R DLBCL KITE-363 (CD19/20 bicistronic) NCT04989803
R/R DLBCL KITE-753 (CD19/20 bicistronic) NCT04989803
2L+ high-risk FL (ZUMA-22) Axicabtagene ciloleucel NCT05371093
R/R Pediatric ALL/NHL (ZUMA-4) Brexucabtagene autoleucel NCT02625480
R/R MM (iMMagine-3)a Anitocabtagene autoleucel NCT06413498
R/R MM (iMMagine-1)a Anitocabtagene autoleucel NCT05396885
R/R MM (Phase 1)a Anitocabtagene autoleucel NCT04155749
Breast 1L mTNBC, PD-L1- (ASCENT-03) Sacituzumab govitecan (SG) NCT05382299
1L mTNBC, PD-L1+ (ASCENT-04)b Sacituzumab govitecan + pembro NCT05382286
Adjuvant TNBC (ASCENT-05)c Sacituzumab govitecan + pembro NCT05633654
HR+/HER2- chemo-naïve mBC (ASCENT-07) Sacituzumab govitecan NCT05840211
2L+ HR+/HER2- mBC (EVER-132-002)d Sacituzumab govitecan NCT04639986
2L+ mTNBC (ASCENT-J02) Sacituzumab govitecan NCT05101096 1/2
Thoracic 1L mNSCLC, PD-L1+, TPS≥50% (EVOKE-03)b Sacituzumab govitecan + pembro NCT05609968
1L mNSCLC, PD-L1 all comers (STAR-121)e Domvanalimab + zimberelimab + chemo NCT05502237
1L mNSCLC (EVOKE-02)b Sacituzumab govitecan ± pembrolizumab ± chemo NCT05186974
1L mNSCLC (ARC-7)e,f Domvanalimab + zimberelimab + etrumadenant NCT04262856
Stage 2-3 resectable NSCLC, 1-2L mNSCLC (VELOCITY-Lung)e Zim ± dom ± etruma ± chemo/SG combinations NCT05633667
1-2L mNSCLC (EDGE-Lung)e Zim ± dom ± quemli ± chemo combinations NCT05676931
GU 1L/2L+ mUC (TROPHY U-01, multicohort) Sacituzumab govitecan + combinations NCT03547973
GI 1L upper GI (STAR-221)e,g Domvanalimab + zimberelimab + chemo NCT05568095
1L/2L+ Upper GI (EDGE-Gastric)e,h Dom + zim ± quemli + chemo combinations NCT05329766
2L+ mCRC (ARC-9)e,i Etruma + zim + chemo ± bev combinations NCT04660812 1b/2
1-2L mPDAC (ARC-8)e,j Zimberelimab ± quemliclustat + chemo NCT04104672
GYN 2L+ mEC (ASCENT-GYN-01)k Sacituzumab govitecan NCT06486441
Other solid tumors Solid tumors (EVER-132-003) Sacituzumab govitecan NCT05119907
Solid tumor basket study (TROPiCS-03)l Sacituzumab govitecan NCT03964727
Solid tumors GS-9716 (MCL-1) + chemo or SG NCT05006794
Solid tumors GS-1811 (CCR8) ± zim NCT05007782
Solid tumors GS-4528 (IL-2 variant) ± zim NCT05840224
Solid tumors GS-0201 (PARP1) ± SG NCT06167317
Solid tumors GS-9911 (DGKα) ± zim NCT06082960
Solid tumors GS-2121 (undisclosed MoA) ± zim NCT06532565
Solid tumorsm XTX301 (IL-12) NCT05684965

Optionable Partner Programsn

Arcus

3 clinical stage programs: Advanced Cancers

MacroGenics

1 clinical stage program: Advanced cancers


Targets

GS-9716 GS-0201 Sacituzumab govitecan Anito-cel Axi-cel, Brexu-cel KITE-197 KITE-363, KITE-753 GS-9911 GS-4528 XTX301 Zim Dom Etruma GS-1811 Quemli GS-2121
MCL-1 PARP1 Trop-2 BCMA CD19 CD19
Nex-gen CAR-T		 CD19/20
bicistronic		 DGKα IL-2 variant IL-12 PD-1 TIGIT A2AR/A2BR CCR8 CD73 undisclosed
MoA

The safety and efficacy of these investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.

aIn collaboration with Arcellx, Inc. bIn collaboration with Merck. cIn collaboration with Alliance Foundation Trials, LLC and National Surgical Adjuvant Breast and Bowel Project Foundation, Inc. dA Phase 3 Asian Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2) Metastatic Breast Cancer (MBC) Who Have Failed at Least 2 Prior Chemotherapy Regimens. eIn collaboration with Arcus Biosciences. fARC-7: zim ± dom ± etruma. gSTAR-221: dom + zim + FOLFOX/CAPOX vs nivo + FOLFOX/CAPOX. hEDGE-Gastric: (1L) dom + zim + FOLFOX, zim + FOLFOX and (2L) dom + zim, zim + quemli. iARC-9: etruma + zim + FOLFOX vs FOLFOX ± bevacizumab, etruma + zim + FOLFOX ± bevacizumab vs rego, and etruma + zim + quemli. jARC-8: quemli + zim + gem/nab-pac. kIn collaboration with the Gynecologic Oncology Group (GOG) Foundation and the European Network of Gynaecological Oncological Trial Groups (ENGOT). lTROPiCS-03: mNSCLC, mSCLC, mHNSCC, mEC. mOperationalized by Xilio Development, Inc. nOptionable Partner Programs: Selected programs listed are optionable partner programs. Gilead has not opted into these programs unless otherwise noted.

1L, first line; 2L, second line; 3L, third line; A2AR/A2BR, adenosine 2A receptor/adenosine 2B receptor; ALL, acute lymphoblastic leukemia; BC, breast cancer; Bev, bevacizumab; CAPOX, capecitabine + oxaliplatin; CCR8, chemokine receptor 8; CD19/20/73, cluster of differentiation 19/20/73; Chemo, chemotherapy; CLL-1, C-type lectin-like molecule-1; CRC, colorectal cancer; DGKα, diacylglycerol kinase alpha; DLBCL, diffuse large B-cell lymphoma; Doce, docetaxel; Dom, domvanalimab; EC, endometrial cancer; Etruma, etrumadenant; FL, follicular lymphoma; FOLFOX, FOLinic acid-Fluororuracil-OXaliplatin regimen; Gem/Nab-pac, gemcitabine/nab-paclitaxel; GI, gastrointestinal; GU, genitourinary; GYN, gynecological; HER2, human epidermal growth factor receptor 2; HNSCC, head and neck squamous cell carcinoma; HR, hormone receptor; IL-2/12, interleukin-2/12; ITIM, immunoreceptor tyrosine-based inhibitory motif; LBCL, large B-cell lymphoma; m, metastatic; MCL-1, myeloid cell leukemia-1; MM, multiple myeloma; MoA, mechanism of action; NCT, national clinical trial; Nivo, nivolumab; NHL, non-Hodgkin lymphoma; NSCLC, non-small cell lung cancer; PARP1, poly adenosine diphosphate (ADP) ribose polymerase 1; Pembro, pembrolizumab; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; PDAC, pancreatic ductal adenocarcinoma; Quemli, quemliclustat; Rego, regorafenib; R/R, relapsed/refractory; SCLC, small cell lung cancer; SG, sacituzumab govitecan; TIGIT, T cell immunoreceptor with immunoglobulin and ITIM domains; TNBC, triple-negative breast cancer; TPS, tumor proportion score; Trop-2, trophoblast cell-surface antigen 2; UC, urothelial cancer; Zim, zimberelimab.

Last updated 11/24

Clinical trials now enrolling

Select to view study design and eligibility criteria

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ZUMA-22
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ZUMA-23
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iMMagine-3
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iMMagine-1

The safety and efficacy of these investigational agents and/or uses have not been established. There is no guarantee that they will become commercially available.

Technology behind our science

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Learn more about the D-Domain

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Welcome to the D-Domain
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CAR T BCMA binders

Welcome to Gilead and Kite Oncology at the 66th ASH Annual Meeting & Exposition

The content on this page is intended for healthcare professionals attending ASH 2024 taking place December 7-10, 2024 in San Diego, California. This site has been designed and funded by Gilead Sciences and Kite, a Gilead company.

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