CD19/CD22 CAR-T cell therapy / Shanghai Yake Biotech - LARVOL DELTA

Dasatinib and CAR-T Cell Therapy for Newly Diagnosed Ph-Positive Acute Lymphoblastic Leukemia in Adults (ASH 2023) - "Dasatinib in combination with a two-week vincristine and glucocorticoids regimen were administered, followed by sequential infusions of CD19 and CD22 CAR-T cells...Results At the cut-off date of 31 May 2023, 18 patients have received CD19 CAR-T cell infusions, and 14 of these patients have received subsequent CD22 CAR-T cell infusions...Conclusions Dasatinib in combination with CAR-T cell therapy has enabled chemotherapy-free treatment in newly diagnosed Ph-positive ALL. This treatment is characterized by high complete molecular response, high long-term survival, low toxicity and short treatment cycles."

CAR T-Cell Therapy • Clinical • IO biomarker • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • CD22

Sequential CD19 and CD22 CAR-T Therapy in Relapsed/Refractory Acute Lymphoblastic Leukemia (ASH 2024) - "Patients underwent CD19 CAR-T cell infusion followed by CD22 CAR-T cell infusion after at least one month. Of the 8 relapsed patients, loss of BCA preceding relapse was observed in 3 cases (37.5%), concurrent loss of BCA and relapse in 4 cases (50%), ongoing BCA in 1 case (12.5%). Conclusion : Sequential CD19 and CD22 CAR-T cell therapy demonstrates durable efficacy and a manageable safety profile in relapsed/refractory B-ALL, providing a promising option to address antigen-loss relapse and improve long-term outcomes in patients ineligible for allo-HSCT."

Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • CD22

Dasatinib and CAR T-Cell Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: A Nonrandomized Clinical Trial. (PubMed, JAMA Oncol) - P2 | "Dasatinib was administered with a 2-week vindesine and dexamethasone regimen as induction, followed by sequential CD19 and CD22 CAR T-cell therapies and single-agent dasatinib maintenance. The primary end point was CMR rate after CD19 CAR T-cell therapy...Further studies with larger cohorts and longer follow-up durations are needed. ClinicalTrials.gov Identifier: NCT04788472."

Clinical • Journal • Acute Lymphocytic Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • CD22

Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph+ B-ALL (clinicaltrials.gov) - P2 | N=28 | Completed | Sponsor: Zhejiang University | Recruiting ➔ Completed | Phase classification: P1/2 ➔ P2 | N=50 ➔ 28 | Trial completion date: Mar 2025 ➔ Aug 2024 | Trial primary completion date: Mar 2024 ➔ Aug 2024

Enrollment change • Phase classification • Trial completion • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD22

Sequential CD19 and CD22 chimeric antigen receptor T-cell therapy for childhood refractory or relapsed B-cell acute lymphocytic leukaemia: a single-arm, phase 2 study. (PubMed, Lancet Oncol) - P2 | "This sequential strategy induced deep and sustained responses with an acceptable toxicity profile, and thus potentially provides long-term benefits for children with this condition."

CAR T-Cell Therapy • Journal • P2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Infectious Disease • Inflammation • Oncology • Transplantation • CD22

Anti-CD19/CD22 Bispecific CAR-T Cell Therapy for MRD Positive ALL (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Trial completion date: Dec 2021 ➔ Jul 2022 | Trial primary completion date: Dec 2021 ➔ Jul 2022

CAR T-Cell Therapy • Minimal residual disease • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD19 • CD22

Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph+ B-ALL (clinicaltrials.gov) - P1/2; N=50; Recruiting; Sponsor: Zhejiang University

Clinical • New P1/2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD19 • CD22

Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph- B-ALL (clinicaltrials.gov) - P1/2; N=50; Recruiting; Sponsor: Zhejiang University

Clinical • New P1/2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukaemia • Hematological Malignancies • Leukemia • Oncology