Review ArticleReview Article
Open Access

CAR T-cell therapy in acute myeloid leukemia

Alhomidi Almotiri
Saudi Medical Journal October 2024, 45 (10) 1007-1019; DOI: https://doi.org/10.15537/smj.2024.45.10.20240330

Article Figures & Data

Figures

  • Figure 1
    Figure 1

    - The timeline of major developments in chimeric antigen receptor T-cell therapy. CML: chronic myeloid leukemia, CAR: chimeric antigen receptor, CRISPR: clustered regularly interspaced short palindromic repeats, FDA: Food and Drug Administration, cTCR: chimeric T-cell receptor, SLE: systemic lupus erythematosus

Tables

  • Table 1

    - Registered clinical trials using chimeric antigen receptor T-cell for acute myeloid leukemia in https://clinicaltrials.gov/ as of 8/3/2024.

    Trial identifiersStudy namesCondition(s)Study typeAntigensPhasesEnrollments†Start datesCompletion datesResponsible partiesStatus
    NCT04033302Multi-CAR T-cell therapy targeting CD7-positive malignanciesAML, T-cell acute lymphoblastic leukemia/lymphoma, NK cell lymphomaInterventionalCD7I/II3020192023Shenzhen Geno-Immune Medical InstituteUnknown
    NCT04762485Humanized CD7 CAR T-cell therapy for r/r CD7+ acute leukemiaAML, T lymphoblastic leukemia/lymphoma, mixed phenotype acute leukemiaInterventionalCD7I/II2020212024The First Affiliated Hospital of Soochow UniversityUnknown
    NCT05377827Dose-escalation and dose-expansion study to evaluate the safety and tolerability of anti-CD7 allogeneic CAR T-cells (WU-CART-007) in patients with CD7+ hematologic malignanciesAML, T-Cell non-Hodgkin lymphoma, othersInterventionalCD7I5420232026Washington University School of MedicineRecruiting
    NCT05995028Universal 4SCAR7U targeting CD7-positive malignanciesAML, T-cell acute lymphoblastic leukemia/lymphoma, NK cell lymphomaInterventionalCD7I3020232026Shenzhen Geno-Immune Medical InstituteRecruiting
    NCT03896854CART-19 T-cell in CD19 positive relapsed or refractory acute myeloid leukemia (AML)AMLInterventionalCD19I/II1520172025Shanghai Unicar-Therapy Bio-medicine Technology Co.,LtdRecruiting
    NCT04796441Clinical study of universal CAR-γδT-cell injection in the treatment of patients with relapsed AML after transplantationAMLInterventionalCD19NA2020202022Hebei Senlang Biotechnology Inc., LtdUnknown
    NCT04257175CAR-T CD19 for acute myelogenous leukemia with t 8:21 and CD19 expressionAMLInterventionalCD19II/III1020202024Sheba Medical CenterRecruiting
    NCT05513612Novel CAR-T cell therapy in the treatment of hematopoietic and lymphoid malignanciesAML, B-NHL, othersInterventionalCD19I020202026Shanghai Pudong HospitalWithdrawn
    NCT05388305Universal CAR-γδT cell injection in the AML patientsAMLInterventionalCD19NA3020222023Hebei Senlang Biotechnology Inc., LtdRecruiting
    NCT01864902Treatment of relapsed or chemotherapy refractory CD33 positive acute myeloid leukemia by CART-33 (CART33)R/R AMLInterventionalCD33I/II1020132017Chinese PLA General HospitalUnknown
    NCT02799680Allogeneic CART-33 for relapsed/refractory CD33+ AMLR/R AMLInterventionalCD33-1220152018The Affiliated Hospital of the Chinese Academy of Military Medical SciencesUnknown
    NCT03971799Study of anti-CD33 chimeric antigen receptor-expressing T-cells (CD33CART) in children and young adults with relapsed/refractory acute myeloid leukemiaAMLInterventionalCD33I/II5220202039Center for International Blood and Marrow Transplant ResearchActive, not recruiting
    NCT05105152PLAT-08: a study of SC-DARIC33 CAR T-cells in pediatric and young adults with relapsed or refractory CD33+ AMLAMLInterventionalCD33I1820212041Colleen Annesley, Seattle Children’s HospitalRecruiting
    NCT04835519Phase I/II study of enhanced CD33 CAR T-cells in subjects with relapsed or refractory acute myeloid leukemiaR/R AMLInterventionalCD33I/II2520212024Beijing Boren HospitalRecruiting
    NCT05672147CD33-CAR T-cell therapy for the treatment of recurrent or refractory acute myeloid leukemiaR/R AMLInterventionalCD33I2720232026City of Hope Medical CenterRecruiting
    NCT05445765Anti-CD33 CAR-T cells for the treatment of relapsed/refractory CD33+ acute myeloid leukemiaR/R AMLInterventionalCD33I10CD3320222024iCell Gene TherapeuticsNot yet recruiting
    NCT05473221Evaluate the safety and efficacy of CD33 CAR-T in patients with R/R AMLAMLInterventionalCD33I2020222025Zhejiang UniversityNot yet recruiting
    NCT05945849CD33KO-HSPC infusion followed by CART-33 infusion(s) for refractory/relapsed AMLR/R AMLInterventionalCD33I1620242044University of PennsylvaniaNot yet recruiting
    NCT05984199Donor-derived anti-CD33 CAR T-cell therapy (VCAR33) in patients with relapsed or refractory AML after allogeneic hematopoietic cell transplantR/R AMLInterventionalCD33I/II2420232026Vor BiopharmaRecruiting
    NCT04351022CD38-targeted chimeric antigen receptor T-cell (CART) in relapsed or refractory acute myeloid leukemiaR/R AMLInterventionalCD38I/II2020172023The First Affiliated Hospital of Soochow UniversityUnknown
    NCT05239689Clinical study of CD38 CAR-T cells in the treatment of hematological malignanciesAMLInterventionalCD38I3620222024Zhejiang UniversityRecruiting
    NCT05442580CART-38 in adult AML and MM patientsAML, MMInterventionalCD38I3620232041University of PennsylvaniaRecruiting
    NCT04662294CD 70 CAR T for patients with CD70 positive malignant hematologic diseasesAML, NHL, MMInterventionalCD70I10820212027Zhejiang UniversityRecruiting
    NCT04692948TAA6 cell injection in the treatment of patients with relapsed/refractory acute myeloid leukemiaAMLInterventionalCD276NA520192023PersonGen BioTherapeutics (Suzhou) Co., Ltd.Unknown
    NCT05731219UTAA06 injection in the treatment of relapsed/refractory acute myeloid leukemiaR/R AMLInterventionalB7-H3 (CD276)I1820222025PersonGen BioTherapeutics (Suzhou) Co., Ltd.Recruiting
    NCT05722171Clinical study of UTAA06 injection in the treatment of relapsed/refractory acute myeloid leukemiaR/R AMLInterventionalB7-H3 (CD276)I1020222024PersonGen BioTherapeutics (Suzhou) Co., Ltd.Recruiting
    NCT03585517Safety and efficacy evaluation of IM23 CAR-T cells (IM23CAR-T)AMLInterventionalCD123I1020182020Beijing Immunochina Medical Science & Technology Co., Ltd.Completed
    NCT02159495Genetically modified T-cell immunotherapy in treating patients with relapsed/refractory acute myeloid leukemia and persistent/recurrent blastic plasmacytoid dendritic cell neoplasmAML, blastic plasmacytoid dendritic cell neoplasmInterventionalCD123-3120152024City of Hope Medical CenterActive, not recruiting
    NCT03114670Donor-derived anti-CD123-CART cells for recurred AML after Allo-HSCTAdult AMLInterventionalCD123-2020172021Affiliated Hospital to Academy of Military Medical SciencesUnknown
    NCT03190278Study evaluating safety and efficacy of UCART123 in patients with relapsed/refractory acute myeloid leukemia (AMELI-01)R/R AMLInterventionalCD123-6520172024Cellectis S.A.Recruiting
    NCT03556982CART-123 for relapsed/refractory scute myelocytic leukemia (AML)R/R AMLInterventionalCD123I/II1020182020The Affiliated Hospital of the Chinese Academy of Military Medical SciencesUnknown
    NCT04265963CD123-targeted CAR-T cell therapy for relapsed/refractory acute myeloid leukemiaAMLInterventionalCD123I/II4520192024Chongqing Precision Biotech Co., LtdRecruiting
    NCT04272125Safety and efficacy of CD123-targeted CAR-T therapy for relapsed/refractory acute myeloid leukemiaAMLInterventionalCD123I/II4020192024Chongqing Precision Biotech Co., LtdRecruiting
    NCT05949125Dose-escalating trial with Allo-RevCAR01-T cells in combination with CD123 target module (R-TM123) for participants with selected hematologic malignancies positive for CD123AMLInterventionalCD123I3720242025AvenCell Europe GmbHRecruiting
    NCT04318678CD123-directed autologous T-cell therapy for acute myelogenous leukemia (CATCHAML)AML, MDS, B-ALL, T-ALL, BPDCNInterventionalCD123I3220202025St. Jude Children’s Research HospitalActive, not Recruiting
    NCT04678336CD123 redirected T-cells for AML in pediatric subjectsR/R AML, pediatric AMLInterventionalCD123I1220212036University of PennsylvaniaActive, not Recruiting
    NCT04884984Anti-CLL1 CAR T-cell therapy in CLL1 positive relapsed/refractory acute myeloid leukemia (AML)AMLInterventionalCLL1I/II2020172024The First Affiliated Hospital of Soochow UniversityRecruiting
    NCT05467202Evaluate the safety and efficacy of CLL1 CAR-T in patients with R/R AMLAMLInterventionalCLL1I2020222025Zhejiang UniversityNot yet recruiting
    NCT04219163Chimeric antigen receptor T-cells for the treatment of AML expressing CLL-1 antigenAMLInterventionalCLL1I/II1820202038Baylor College of MedicineRecruiting
    NCT04923919Clinical study of chimeric antigen receptor T lymphocytes (CAR-T) in the treatment of myeloid leukemiaAMLInterventionalCLL1I10020212024920th Hospital of Joint Logistics Support Force of People’s Liberation Army of ChinaRecruiting
    NCT05252572Clinical study of CLL1 CAR-T cells in the treatment of hematological malignanciesAMLInterventionalCLL1I3620222024Zhejiang UniversityRecruiting
    NCT06128044CRISPR-edited allogeneic anti-CLL-1 CAR-T cell therapy in patients with relapsed/refractory acute myeloid leukemia (AMpLify)R/R AMLInterventionalCLL1I7020232028Caribou Biosciences, Inc.Recruiting
    NCT06118788Phase I clinical study: BG1805 injection in the treatment of relapsed or refractory acute myeloid leukemiaR/R AMLInterventionalCLL1I2420232025Guangzhou Bio-gene Technology Co., LtdNot yet recruiting
    NCT05023707Anti-FLT3 CAR T-cell therapy in FLT3 positive relapsed/refractory acute myeloid leukemiaR/R AMLInterventionalFLT3I/II520212025The First Affiliated Hospital of Soochow UniversityRecruiting
    NCT05432401TAA05 injection in the treatment of adult patients with FLT3-positive relapsed/refractory acute myeloid leukemiaFLT3-positive R/R AMLInterventionalFLT3I1820222025PersonGen BioTherapeutics (Suzhou) Co., Ltd.Recruiting
    NCT05445011Anti-FLT3 CAR-T cell (TAA05 cell injection) in the treatment of relapsed/refractory acute myeloid leukemiaAMLInterventionalFLT3I1220222027Wuhan Union Hospital, ChinaRecruiting
    NCT03018405A dose escalation Phase I study to assess the safety and clinical activity of multiple cancer indications (THINK)MDS/AML/MMInterventionalNKG2D-/II14620162021Celyad Oncology SAUnknown
    NCT04658004NKG2D CAR-T cell therapy for patients with relapsed or refractory acute myeloid leukemiaAMLInterventionalNKG2DI3620212027Zhejiang UniversityNot yet recruiting
    NCT04599543IL3 CAR-T cell therapy for patients with CD123 positive relapsed or refractory acute myeloid leukemiaAMLInterventionalIL3I3620202026Zhejiang UniversityNot yet recruiting
    NCT05266950Safety and efficacy study of CI-135 CAR-T cells in subjects with relapsed or refractory acute myeloid leukemiaAMLInterventionalCI-135I720212025Beijing Boren HospitalRecruiting
    NCT04803929Clinical study of anti-ILT3 CAR-T therapy for R/R AML (M4/M5)R/R AML (M4/M5)InterventionalILT3I2520212026Carbiogene Therapeutics Co. Ltd.Recruiting
    NCT05463640Evaluate the safety and efficacy of ADGRE2 CAR-T in patients with R/R AMLAMLInterventionalADGRE2I2020222025Zhejiang UniversityNot yet recruiting
    NCT05488132Administration of anti-siglec-6 CAR-T cell therapy in relapsed and refractory acute myeloid leukemia (rr/AML)R/R AMLInterventionalSiglec-6I/II2020222025Xuzhou Medical UniversityRecruiting
    NCT06197672Chimeric antigen receptor T-cell redirected to target CD4 positive relapsed refractory acute myeloid leukemia (AML) as a bridge to allogeneic stem cell transplantR/R AMLInterventionalCD4I3020242042Indiana UniversityNot yet recruiting
    NCT06281847An adaptive open-label multicentre Phase 1/2 trial, to determine the recommended Phase 2 dose of CCTx-001, and to assess safety, tolerability, and clinical activity in patients with relapsed/refractory acute myeloid leukaemia (RESOLVE AML001)R/R AMLInterventionalIL-1RAPI/II14320242041Advesya SASNot yet recruiting
    NCT06017258A study of CD371-YSNVZIL-18 CAR T-cells in people with acute myeloid leukemiaAMLInterventionalCD371I620232026Memorial Sloan Kettering Cancer CenterRecruiting
    NCT05016063Dual CD33-CLL1-CAR-T cells in the treatment of relapsed/refractory acute myeloid leukemiaAMLInterventionalCD33/CLL1I3220212023Xinqiao Hospital of ChongqingUnknown
    NCT05248685Optimized dual CD33/CLL1 CAR T-cells in subjects with refractory or relapsed acute myeloid leukemiaAMLInterventionalCD33/CLL1I2020222024Beijing Boren HospitalUnknown
    NCT03795779CLL1-CD33 cCAR in patients with relapsed or refractory, high risk hematologic malignanciesAML, MDS, MPN, CMLInterventionalCLL1/CD33I2020182022iCell Gene TherapeuticsUnknown
    NCT05467254Evaluate the safety and efficacy of CLL1+CD33 CAR-T in patients with R/R AMLAMLInterventionalCLL1/CD33I2020222025Zhejiang UniversityNot yet recruiting
    NCT06110208Study to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual CAR-T in r/r AMLR/R AMLInterventionalCLL1/CD38I1820232026920th Hospital of Joint Logistics Support Force of People’s Liberation Army of ChinaRecruiting
    NCT04010877Multiple CAR-T cell therapy targeting AMLAMLInterventionalCLL1, CD33, CD123I/II1020192023Shenzhen Geno-Immune Medical InstituteUnknown
    NCT03222674Multi-CAR T-cell therapy for acute myeloid leukemiaAMLInterventionalMuc1/CLL1/CD33/CD38/CD56/CD123I/II1020172020Shenzhen Geno-Immune Medical InstituteUnknown
    NCT03291444CAR-T cells combined with peptide specific dendritic cell in relapsed/refractory leukemia/MDSAMLInterventionalCD33, CD38, CD56, CD117, CD123, CD34, Muc1I3020172025Zhujiang HospitalRecruiting
    NCT05995041Universal CAR-T cells targeting AMLR/R AMLInterventionalCLL-1, CD33, CD38, CD123I3020232026Shenzhen Geno-Immune Medical InstituteRecruiting
    NCT04766840Donor-derived CAR-T cells in the treatment of AML patientsAMLInterventionalnot shownI920212023Beijing Immunochina Medical Science & Technology Co., Ltd.Unknown
    NCT03473457CAR-T cells therapy in relapsed/refractory acute myeloid leukemia (AML)R/R AMLInterventionalNot shownNA220182020Zhujiang HospitalTerminated*
    NCT04097301Study of CAR T-cell therapy in acute myeloid leukemia and multiple myelomaR/R AML, MMInterventionalCD44v6I/II820192021AGC Biologics S.p.ATerminated∆

    CAR: chimeric antigen receptor, AML: acute myeloid leukemia, NK: natural killer, B-NHL: B-cell non-Hodgkin lymphomas, R/R: relapsed/refractory, NA: not applicable MM: multiple myeloma

    • ↵† The ‘estimated’ enrollment is the target number of participants that the researchers need for the study.

    • ↵* The therapeutic effect was not as expected.

    • ↵∆ Inability to close the study in a clinically relevant time frame.

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