^
1m
Efficacy of VTP-300 in Chronic Hepatitis B Infection (clinicaltrials.gov)
P2, N=120, Active, not recruiting, Barinthus Biotherapeutics | Recruiting --> Active, not recruiting | Phase classification: P2b --> P2 | Trial completion date: Aug 2024 --> Oct 2026 | Trial primary completion date: May 2024 --> Feb 2025
Enrollment closed • Phase classification • Trial completion date • Trial primary completion date
|
Opdivo (nivolumab)
3ms
Enrollment change
|
Opdivo (nivolumab) • IMA203 • IMA203CD8
3ms
First-In-Human Study of ChAdOx1-HBV & MVA-HBV Vaccines (VTP-300) for Chronic HBV (clinicaltrials.gov)
P1/2, N=55, Completed, Barinthus Biotherapeutics | Active, not recruiting --> Completed | Phase classification: P1b/2a --> P1/2
Trial completion • Phase classification
|
Opdivo (nivolumab)
4ms
TRIGGERCD8: A Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=194, Recruiting, L & L biopharma Co., Ltd., Shanghai China | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy • Metastases
|
LB1410 • LB4330
4ms
Phase 1b/2a randomized study of heterologous ChAdOx1-HBV/MVA-HBV therapeutic vaccination (VTP-300) as monotherapy and combined with low-dose nivolumab in virally-suppressed patients with chronic hepatitis B. (PubMed, J Hepatol)
VTP-300 induced CD4+ and CD8+ T cells and lowered HBsAg in a subset of patients with baseline values below 100 IU/ml. The addition of LDN resulted in significant reduction in surface antigen. VTP-300 is a promising immunotherapeutic to move forward alone or in combination therapies.
P1/2 data • Journal
|
CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
Opdivo (nivolumab)
5ms
New P1/2 trial • Combination therapy • Metastases
|
LB1410 • LB4330
5ms
ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURPASS-3) (clinicaltrials.gov)
P2, N=66, Recruiting, Adaptimmune | Trial completion date: Oct 2025 --> Aug 2026 | Trial primary completion date: Oct 2025 --> Aug 2026
Trial completion date • Trial primary completion date • Combination therapy
|
HLA-A (Major Histocompatibility Complex, Class I, A) • BRCA (Breast cancer early onset) • PARP1 (Poly(ADP-Ribose) Polymerase 1) • MAGEA4 (Melanoma antigen family A, 4)
|
Opdivo (nivolumab) • uzatresgene autoleucel (ADP-A2M4CD8)
6ms
HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB) (clinicaltrials.gov)
P2, N=87, Terminated, Altimmune, Inc. | Trial completion date: Sep 2024 --> Apr 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Oct 2023 --> Mar 2024; Did not meet endpoints
Trial completion date • Trial termination • Trial primary completion date
6ms
KEYNOTE-E29: A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors (clinicaltrials.gov)
P1, N=462, Recruiting, Asher Biotherapeutics, Inc. | N=262 --> 462 | Trial completion date: Oct 2025 --> May 2027 | Trial primary completion date: Jun 2025 --> Aug 2026
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • AB248
7ms
ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2) (clinicaltrials.gov)
P2, N=3, Terminated, Adaptimmune | N=45 --> 3 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2023 --> Apr 2023; Study was terminated due to difficulty recruiting subjects and lack of efficacy
Enrollment change • Trial termination • Trial primary completion date • Metastases
|
HLA-A (Major Histocompatibility Complex, Class I, A) • MAGEA4 (Melanoma antigen family A, 4)
|
HLA-A*02 • HLA-A2 positive • MAGEA4 expression
|
uzatresgene autoleucel (ADP-A2M4CD8)
8ms
IL-2 targeted to CD8+ T cells promotes robust effector T cell responses and potent antitumor immunity. (PubMed, Cancer Discov)
Efficacy was associated with expansion and phenotypic enhancement of tumor-infiltrating CD8+ T cells, including the emergence of a "better effector" population. These data support the potential utility of AB248 in clinical settings.
Journal
|
CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
|
AB248
8ms
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of LB4330 in Patients With Advanced Solid Tumors(MEETCD8-001) (clinicaltrials.gov)
P1, N=66, Recruiting, L & L biopharma Co., Ltd., Shanghai China | Trial primary completion date: Sep 2026 --> Sep 2025
Trial primary completion date • Metastases
|
LB4330
9ms
Trial primary completion date • Combination therapy
|
HLA-A (Major Histocompatibility Complex, Class I, A) • MAGEA4 (Melanoma antigen family A, 4)
|
HLA-A*02 • MAGEA4 expression
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • uzatresgene autoleucel (ADP-A2M4CD8)
10ms
Antigen-specific T Cell Therapy for Patients With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov)
P1/2, N=9, Suspended, NexImmune Inc. | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Nov 2023 --> Nov 2024
Trial completion date • Trial primary completion date
|
HLA-A (Major Histocompatibility Complex, Class I, A)
|
NEXI-002
10ms
Antigen-specific T Cell Therapy for AML or MDS Patients With Relapsed Disease After Allo-HCT (clinicaltrials.gov)
P1/2, N=22, Active, not recruiting, NexImmune Inc. | Recruiting --> Active, not recruiting | Trial completion date: Mar 2023 --> Mar 2025 | Trial primary completion date: Oct 2022 --> Oct 2024
Enrollment closed • Trial completion date • Trial primary completion date
|
HLA-A (Major Histocompatibility Complex, Class I, A) • HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-DQB1 (Major Histocompatibility Complex, Class II, DQ Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
|
cyclophosphamide • NEXI-001
10ms
Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R/R HPV-related Oropharyngeal Cancers (clinicaltrials.gov)
P1, N=36, Not yet recruiting, NexImmune Inc. | Trial completion date: Aug 2025 --> Aug 2027 | Trial primary completion date: Jul 2024 --> Jul 2026
Trial completion date • Trial primary completion date
|
HLA-A (Major Histocompatibility Complex, Class I, A)
|
cyclophosphamide • fludarabine IV • NEXI-003
11ms
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • AB248
11ms
Recombinant Interleukin-15 in Combination With Checkpoint Inhibitors Nivolumab and Ipilimumab in People With Refractory Cancers (clinicaltrials.gov)
P1, N=50, Recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition
|
PD-L1 (Programmed death ligand 1)
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • rhIL-15
almost1year
Phase classification • Combination therapy • Metastases
|
Keytruda (pembrolizumab) • AB248
1year
Phase 1 trial of 4-1BB-based adoptive T-cell therapy targeting human telomerase reverse transcriptase in patients with advanced refractory solid tumors. (PubMed, Cytotherapy)
The generation of TERTiNTs was feasible and safe and provided an interesting disease control rate in heavily pre-treated cancer patients.
P1 data • Clinical Trial,Phase I • Journal • Metastases
|
CD8 (cluster of differentiation 8) • TERT (Telomerase Reverse Transcriptase)
|
cyclophosphamide • fludarabine IV • EU204 • EU211
1year
A PHASE 2b, OPEN-LABEL STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, IMMUNOGENICITY AND TREATMENT REGIMENS OF VTP-300 COMBINED WITH LOW-DOSE NIVOLUMAB IN CHRONIC HEPATITIS B INFECTION (AASLD 2023)
VTP-300 is a novel antigen-specific investigational immunotherapy which has shown (in a Phase 1b/2a study) meaningful and durable HBsAg reductions in patients with HBV as a monotherapy and in combination with LDN. Evaluating the addition and timing of PD-1 inhibitor administration and a second boost of MVA-HBV is critical to optimizing the regimen of VTP-300 which may be a critical component of a functional cure regimen.
Clinical • P2b data
|
CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
|
Opdivo (nivolumab)
over1year
Clinical and translational data from the phase I SURPASS trial of ADP-A2M4CD8 T cell receptor (TCR) T cell therapy alone or combined with nivolumab in solid tumors (ESMO 2023)
Nevertheless, inhibition of immunosuppressive pathways may improve anti-tumor responses; therefore, new SURPASS cohorts include ADP-A2M4CD8 combined with nivolumab or pembrolizumab. Data from additional pts treated by August 2023 will be presented. Conclusions ADP-A2M4CD8 continues to show an acceptable benefit-to-risk profile, including in pts receiving nivolumab combination therapy.
Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker
|
MAGEA4 (Melanoma antigen family A, 4)
|
MAGEA4 expression
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • uzatresgene autoleucel (ADP-A2M4CD8)
over1year
A Phase 2 Study (GOG-3084) Of ADP-A2M4CD8 TCR T-Cell Therapy, Alone Or In Combination With Nivolumab, In Patients With Recurrent Ovarian Cancers (ESGO 2023)
Lymphodepletion chemotherapy (fludarabine 30 mg/m2/day for 4 days and cyclophosphamide 600 mg/m2/day for 3 days) will be followed by infusion of 1â10x10^9 ADP-A2M4CD8 T-cells. Adverse events will be monitored, with participants followed for 15 years from T-cell infusion. Conclusion SURPASS-3 is initiating in Q2 2023.
Clinical • P2 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker
|
CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A) • CD4 (CD4 Molecule) • MAGEA4 (Melanoma antigen family A, 4)
|
CD8 expression • HLA-A*02 • HLA-A*02:01 + MAGEA4 expression • MAGEA4 expression
|
Opdivo (nivolumab) • cyclophosphamide • fludarabine IV • uzatresgene autoleucel (ADP-A2M4CD8)
over1year
ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURPASS-3) (clinicaltrials.gov)
P2, N=66, Recruiting, Adaptimmune | Not yet recruiting --> Recruiting | Initiation date: Mar 2023 --> Jun 2023
Enrollment open • Trial initiation date • Combination therapy
|
HLA-A (Major Histocompatibility Complex, Class I, A) • BRCA (Breast cancer early onset) • PARP1 (Poly(ADP-Ribose) Polymerase 1) • MAGEA4 (Melanoma antigen family A, 4)
|
HLA-A*02:01 • HLA-A*02 • BRCA mutation • HLA-A2 positive • MAGEA4 expression
|
Opdivo (nivolumab) • uzatresgene autoleucel (ADP-A2M4CD8)
over1year
ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2) (clinicaltrials.gov)
P2, N=45, Active, not recruiting, Adaptimmune | Trial primary completion date: Apr 2023 --> Dec 2023
Trial primary completion date • Metastases
|
HLA-A (Major Histocompatibility Complex, Class I, A) • MAGEA4 (Melanoma antigen family A, 4)
|
HLA-A*02 • HLA-A2 positive • MAGEA4 expression
|
uzatresgene autoleucel (ADP-A2M4CD8)
over1year
Clinical • P1 data • PK/PD data • PD(L)-1 Biomarker • IO biomarker • Metastases
|
CLDN18 (Claudin 18) • CD8 (cluster of differentiation 8)
|
LB4330
over1year
An analysis of a first-in-human study of NEXI-001 donor-derived antigen-specific CD8+ T-cell treatment of relapsed AML after allogeneic hematopoietic cell transplantation (HCT). (ASCO 2023)
Early results indicate that the antigen-specific NEXI-001 T cells have the potential to enhance GvL effects and is tolerated with easily manageable side effects. Greater clinical activity has been observed with increased doses of the NEXI-001 T cells. The trial remains ongoing, and the data support an Expansion Cohort of the study that will allow for a more complete assessment of clinical activity.
P1 data
|
CD8 (cluster of differentiation 8) • WT1 (WT1 Transcription Factor) • CD4 (CD4 Molecule) • PRAME (Preferentially Expressed Antigen In Melanoma) • CCNA1 (Cyclin A1)
|
NEXI-001
over1year
Modulation of Single-Cell Gene Expression and Cell Function in Evolving Manufacturing Processes for Clinical Trials with Enhanced-Affinity T-Cell Receptor T-Cell Therapy Targeting the MAGE-A4 Antigen in Solid Tumors (ASGCT 2023)
Introduction: Affinity-enhanced T-cell receptor (TCR) T-cell therapies targeting the intracellular cancer testis antigen MAGE-A4 have shown encouraging results in adults with advanced solid cancers.1,2 Here we explore how TCR T-cell therapy manufacturing process evolution may modulate the function of ADP-A2M4CD8, the next generation counterpart of afamitresgene autoleucel (afami-cel; formerly ADP-A2M4), using single-cell RNA sequencing (scRNA-seq) and in vitro functional assessment. Whole-transcriptome, single-cell investigation of the cellular subsets produced during manufacturing of afami-cel and ADP-A2M4CD8 indicate that infusion of cells with a less cytotoxic GEP does not prevent broad anti-tumor efficacy and may correspond with beneficial characteristics. 1. Van Tine BA, et al.
Clinical • IO biomarker
|
CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • MAGEA4 (Melanoma antigen family A, 4)
|
Tecelra (afamitresgene autoleucel) • uzatresgene autoleucel (ADP-A2M4CD8)
over1year
ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2) (clinicaltrials.gov)
P2, N=45, Active, not recruiting, Adaptimmune | Recruiting --> Active, not recruiting | Trial completion date: Oct 2038 --> Dec 2023
Enrollment closed • Trial completion date • Metastases
|
HLA-A (Major Histocompatibility Complex, Class I, A) • MAGEA4 (Melanoma antigen family A, 4)
|
HLA-A*02 • HLA-A2 positive • MAGEA4 expression
|
uzatresgene autoleucel (ADP-A2M4CD8)
over1year
An open-label, phase 1a/b study of AB248, a CD8+ selective IL-2 mutein fusion protein, alone or in combination with pembrolizumab in patients with advanced solid tumors (AACR 2023)
Adverse events will be assessed by CTCAE v5.0. The study is currently open for enrollment in the dose escalation phase at multiple sites in the US.
Clinical • P1 data • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
|
CD8 (cluster of differentiation 8) • IL2 (Interleukin 2)
|
Keytruda (pembrolizumab) • AB248
over1year
Increasing the Awareness of Nurses on Evolving Cell Therapies (ONS 2023)
Purpose: This abstract presents data on two cell therapies being tested in clinical trials, afamitresgene autoleucel (afami-cel; formerly ADP-A2M4) and its next-generation counterpart ADP-A2M4CD8, to inform nurses on new promising therapies...SURPASS (NCT04044859) is a Phase 1, first-in-human trial evaluating ADP-A2M4CD8 as monotherapy or in combination with nivolumab in multiple tumor types... Nurses play key roles at every stage in the administration of T-cell therapy. Understanding advances in cancer treatment and associated clinical data will better prepare nurses to effectively manage patients that may benefit from these novel therapies.
Late-breaking abstract • PD(L)-1 Biomarker • IO biomarker
|
CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A) • CD4 (CD4 Molecule)
|
HLA-A*02
|
Opdivo (nivolumab) • Tecelra (afamitresgene autoleucel) • uzatresgene autoleucel (ADP-A2M4CD8)
almost2years
Enrollment change • Combination therapy
|
HLA-A (Major Histocompatibility Complex, Class I, A) • MAGEA4 (Melanoma antigen family A, 4)
|
HLA-A*02 • MAGEA4 expression
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • uzatresgene autoleucel (ADP-A2M4CD8)
almost2years
New P1 trial • Metastases
|
CLDN18 (Claudin 18)
|
LB4330
almost2years
Enrollment change • Metastases
|
BRAF (B-raf proto-oncogene)
|
BRAF mutation
|
nemvaleukin alfa (ALKS 4230)
almost2years
A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors (clinicaltrials.gov)
P1a/1b, N=262, Recruiting, Asher Biotherapeutics, Inc. | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy • Metastases
|
CD8 (cluster of differentiation 8)
|
Keytruda (pembrolizumab) • AB248
almost2years
Phase I Study of Recombinant Human IL-15 (rhIL-15) and Mogamulizumab for People With Refractory or Relapsed Adult T-Cell Leukemia and Mycosis Fungoides/Sezary Syndrome (clinicaltrials.gov)
P1, N=6, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Sep 2023 --> May 2022
Trial completion • Trial completion date
|
TNFRSF8 (TNF Receptor Superfamily Member 8) • IL15 (Interleukin 15)
|
Poteligeo (mogamulizumab-kpkc) • rhIL-15
almost2years
A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
P1a/1b, N=170, Recruiting, HiFiBiO Therapeutics | Phase classification: P1 --> P1a/1b | N=90 --> 170 | Trial completion date: Jan 2024 --> Dec 2024 | Trial primary completion date: Jan 2024 --> Dec 2024
Phase classification • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
BRAF (B-raf proto-oncogene)
|
BRAF V600
|
Tevimbra (tislelizumab-jsgr) • HFB200301
almost2years
Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R/R HPV-related Oropharyngeal Cancers (clinicaltrials.gov)
P1, N=36, Not yet recruiting, NexImmune Inc. | Initiation date: Dec 2022 --> Mar 2023
Trial initiation date
|
HLA-A (Major Histocompatibility Complex, Class I, A) • CD4 (CD4 Molecule)
|
cyclophosphamide • fludarabine IV • NEXI-003
almost2years
New P1 trial • Combination therapy • Metastases
|
CD8 (cluster of differentiation 8)
|
Keytruda (pembrolizumab) • AB248
almost2years
Antigen-specific T Cell Therapy for Patients With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov)
P1/2, N=9, Suspended, NexImmune Inc. | Trial completion date: Nov 2022 --> Dec 2023 | Terminated --> Suspended | Trial primary completion date: Aug 2022 --> Nov 2023
Trial completion date • Trial suspension • Trial primary completion date
|
HLA-A (Major Histocompatibility Complex, Class I, A)
|
NEXI-002