Clinical trials: Fludarabine
Refractory Autoimmune Diseases
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory…
- Trial name
- NCT07115745
- Testing
- BMS-986515, Fludarabine, Cyclophosphamide
- Where
- 28 sites in United States, Australia and 8 more
- Volunteers
- 125 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Refractory Diffuse Large B Cell Lymphoma (DLBCL), Relapsed Diffuse Large B Cell Lymphoma
DALY II USA/ MB-CART2019.1 for DLBCL
DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and/or refractory B cell lymphoma (BCL).
- Conditions
- Refractory Diffuse Large B Cell Lymphoma (DLBCL), Relapsed Diffuse Large B Cell Lymphoma, High Grade B-cell Lymphoma (HGBCL), Primary Mediastinal B-cell Lymphoma (PMBCL)
- Trial name
- NCT04792489
- Testing
- zamtocabtagene autoleucel (MB-CART2019.1), Cyclophosphamide, Fludarabine
- Where
- 32 sites in United States, Canada
- Volunteers
- 315 people
- Sponsor
- Miltenyi Biomedicine GmbH
Mesothelioma, Mesotheliomas Pleural
A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
TC-510 is a novel cell therapy that consists of autologous genetically engineered T cells expressing two synthetic constructs: first, a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit…
- Conditions
- Mesothelioma, Mesotheliomas Pleural, Mesothelioma, Malignant, Mesothelioma Peritoneum
- Trial name
- NCT05451849
- Testing
- TC-510, Fludarabine, Cyclophosphamide
- Where
- 7 sites in United States
- Volunteers
- 14 people
- Sponsor
- TCR2 Therapeutics
CLL/SLL, NHL
Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies
This is a first-in-human phase 1 study of SYNCAR-001 + STK-009 in patients with CD19+ hematologic malignancies.
- Conditions
- CLL/SLL, NHL, Mantle Cell Lymphoma, Follicular Lymphoma
- Trial name
- NCT05665062
- Testing
- SYNCAR-001, STK-009, Cyclophosphamide
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- Synthekine
FLT3-mutated Acute Myeloid Leukemia
A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML
This study will evaluate the safety, efficacy and pharmacokinetics of midostaurin in combination with standard chemotherapy in pediatrics patients with newly diagnosed FLT3-mutated Acute Myeloid Leukemia.
- Trial name
- NCT03591510
- Testing
- Midostaurin, Fludarabine, Cytarabine
- Where
- 15 sites in Czechia, Germany and 8 more
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Immune Thrombocytopenia, Autoimmune Hemolytic Anemia
Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE)
The purpose of this study is to evaluate the safety and efficacy of Zola-cel (BMS-986353), in participants with chronic immune thrombocytopenia (cITP) and autoimmune hemolytic anemia (AIHA).
- Trial name
- NCT07603557
- Testing
- BMS-986353, Fludarabine Phosphate, Cyclophosphamide
- Where
- 8 sites in United States, Denmark and 2 more
- Volunteers
- 52 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Relapsed Large B-cell Lymphoma, Refractory Large B-cell Lymphoma
Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia Patients
This is a multi-center, phase I/II study to determine the efficacy and safety of CRC01 in adult patients with relapsed or refractory large B-cell lymphoma and B-cell Acute Lymphoblastic Leukemia.
- Conditions
- Relapsed Large B-cell Lymphoma, Refractory Large B-cell Lymphoma, Diffuse Large B-cell Lymphoma (DLBCL), Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
- Trial name
- NCT04836507
- Testing
- CRC01, Fludarabine, Cyclophosphamide
- Where
- 2 sites in South Korea
- Volunteers
- 91 people
- Sponsor
- Curocell Inc.
B-cell Lymphoma, Non Hodgkin Lymphoma
ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies
ACE1831 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment of CD20-expressing B-cell malignancies.
- Conditions
- B-cell Lymphoma, Non Hodgkin Lymphoma, DLBCL, Primary Mediastinal Large B Cell Lymphoma
- Trial name
- NCT05653271
- Testing
- Cyclophosphamide, Fludarabine, ACE1831
- Where
- 13 sites in United States, Hong Kong and 1 more
- Volunteers
- 16 people
- Sponsor
- Acepodia Biotech, Inc.
Relapsed/Refractory Mantle Cell Lymphoma, Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia
The goal of this clinical study is to learn more about KTE-X19, and how safe and effective it is in adult Japanese participants with relapsed/refractory (r/r) Mantle Cell Lymphoma (MCL) or r/r B-precursor Acute Lymphoblastic…
- Trial name
- JKART-1 (NCT06253663)
- Testing
- KTE-X19, Cyclophosphamide, Fludarabine
- Where
- 9 sites in Japan
- Volunteers
- 25 people
- Sponsor
- Kite, A Gilead Company
Acute Myeloid Leukemia (AML)
Anti-CD33-CLL1 CAR-T Cells (ICG415) for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
This single-arm, open-label phase I trial evaluates the safety and tolerability of ICG415, autologous CAR-T cells targeting CD33 and CLL1, in patients with relapsed or refractory acute myeloid leukemia (AML).
- Trial name
- ICG415-AML-01 (NCT07668557)
- Testing
- Anti-CD33-CLL1 CAR-T cells (ICG415) following lymphodepleting fludarabine and cyclophosphamide
- Where
- 2 sites in China
- Volunteers
- 18 people
- Sponsor
- iCell Gene Therapeutics
Lupus Nephritis, Systemic Lupus Erythematosus
US Zamto-cel Autoimmune Diseases
AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory autoimmune diseases (SLE-Non renal, SLE-LN, SSc/dcSSc) after receiving standard…
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Diffuse Cutaneous Systemic Sclerosis
- Trial name
- NCT06708845
- Testing
- zamtocabtagene autoleucel, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Miltenyi Biomedicine GmbH
Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma
Dual-Target HER2/CEA CAR-NK Cells in Advanced Biliary Tract Cancer
This example phase 1/2, open-label, biomarker-selected study evaluates EB-HC01, an allogeneic dual-target CARNK product composed of a 1:1 mixture of HER2-CAR-NK and CEACAM5-CAR-NK cells, in adults with unresectable or metastatic…
- Conditions
- Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Extrahepatic Cholangiocarcinoma, Gallbladder Carcinoma
- Trial name
- DUET-BTC (NCT07641036)
- Testing
- EB-HC01 dual-target CARNK cells, Fludarabine, Cyclophosphamide
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Beijing Biotech
Metastatic Castration-resistant Prostate Cancer, Advanced Prostate Adenocarcinoma
Dual-target PSMA/PSCA CAR-NK Cells in Advanced Prostate Cancer
This example Phase 1 study is designed to evaluate the safety, tolerability, feasibility, and preliminary anti-tumor activity of ETB-DualNK-01, an allogeneic dual-target PSMA/PSCA CAR-NK cell therapy, in adults with metastatic…
- Conditions
- Metastatic Castration-resistant Prostate Cancer, Advanced Prostate Adenocarcinoma, PSCA-positive Prostate Cancer, PSMA-Positive Progressive Metastatic Castration-Resistant Prostate Cancer
- Trial name
- DUAL-NK-PC (NCT07641049)
- Testing
- ETB-DualNK-01, Fludarabine, Cyclophosphamide
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Beijing Biotech
Acute Myeloid Leukaemia
A Study to Investigate Use of Off-the-shelf Natural Killer (NK) Cells (SAR445419) in Relapsed/Refractory Acute Myeloid Leukemia
This is a single group, Phase 1, single-arm, dose escalation study to determine the candidate dose(s), and evaluate safety, tolerability, and preliminary anti-tumor activity of SAR445419 administered after fludarabine and…
- Trial name
- NCT05712278
- Testing
- SAR445419, fludarabine, cytarabine
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- Sanofi
Lupus Nephritis, Primary Membranous Nephropathy
A Phase 1/2 Study of NKX019 in Subjects With Autoimmune Disease (Ntrust-1)
This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in…
- Trial name
- NCT06557265
- Testing
- NKX019, Fludarabine, Cyclophosphamide
- Where
- 19 sites in United States, Australia and 1 more
- Volunteers
- 120 people
- Sponsor
- Nkarta, Inc.
Unresectable Melanoma, Metastatic Cutaneous Melanoma
Dual-Target CSPG4/GD2 CAR-NK Cells for Advanced Melanoma
This is a first-in-human, open-label, multicenter phase 1/2 study evaluating the safety, feasibility, recommended phase 2 dose (RP2D), and preliminary antitumor activity of allogeneic dual-target CSPG4/GD2 CAR-NK cells…
- Conditions
- Unresectable Melanoma, Metastatic Cutaneous Melanoma, Metastatic Uveal Melanoma
- Trial name
- DUET-MEL (NCT07627698)
- Testing
- EB-DTKN-401 allogeneic dual-target CSPG4/GD2 CAR-NK cells, Fludarabine, Cyclophosphamide
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Beijing Biotech
Pancreatic Ductal Adenocarcinoma (PDAC), Unresectable Locally Advanced
Dual-Target CAR-NK Cells Targeting Mesothelin (MSLN) and MUC1 in Advanced Pancreatic Ductal Adenocarcinoma
This example study evaluates the safety, tolerability, and preliminary anti-tumor activity of investigational, dual-targeting chimeric antigen receptor natural killer (CAR-NK) cell products for patients with advanced pancreatic…
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC), Unresectable Locally Advanced, Metastatic Disease
- Trial name
- DUAL-NK-PDAC (NCT07627711)
- Testing
- EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1), EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1), Lymphodepleting chemotherapy (Flu/Cy)
- Where
- China
- Volunteers
- 42 people
- Sponsor
- Beijing Biotech
Recurrent or Metastatic Esophageal Adenocarcinoma, Biomarker-selected CLDN18.2-positive and/or HER2-positive Disease
Dual-Target CLDN18.2/HER2 CAR-NK Cells for Advanced Esophageal Adenocarcinoma
This example study evaluates the safety, feasibility, cellular kinetics, and preliminary anti-tumor activity of EBNK-1822H2, an illustrative allogeneic cord blood-derived dual-target CAR-NK cell product directed against CLDN18.2…
- Trial name
- NCT07622940
- Testing
- EBNK-1822H2 dual-target CLDN18.2/HER2 CAR-NK cells, Fludarabine, Cyclophosphamide
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Beijing Biotech
Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma, Biomarker-positive EGFR/HER2- Expressing HNSCC
EGFR/HER2 Dual-Target CAR-NK Cells for Recurrent or Metastatic HNSCC
This example Phase 1/2 protocol evaluates allogeneic EGFR/HER2 dual-target CAR-NK cells in adults with recurrent or metastatic HNSCC whose tumors meet protocol-defined co-expression criteria for EGFR and HER2/ERBB2.
- Trial name
- DUAL-HN (NCT07617805)
- Testing
- EGFR/HER2 Dual-Target CAR-NK Cells, Fludarabine, Cyclophosphamide
- Where
- China
- Volunteers
- 42 people
- Sponsor
- Beijing Biotech
Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe…
- Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06308978
- Testing
- FT819, Fludarabine, Cyclophosphamide
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 244 people
- Sponsor
- Fate Therapeutics