This resulted in sustained complete remission at the 306-day follow-up, without experiencing any severe complications. This case suggests that combining myeloablative ASCT with tandem anti-CD19/CD22 CAR T cell therapy could be an effective approach for R/R BL, warranting further clinical validation.

Not available.

Therapeutically relevant doses of CD19/CD22 CAR-T cells can be successfully manufactured from whole blood. On average, 80 mL of whole blood yields enough CAR-T cells to create a single dose for a pediatric patient (50 kg) at a dosage of 1 × 106 CAR-T cells/kg. For larger patients, scaling up is straightforward by collecting a larger blood volume. This method also demonstrates a cost-effective approach to T cell activation and expansion which, alongside a more straightforward collection of whole blood, makes it more widely accessible especially for middle- and low-income countries. By reducing costs and labor, this strategy has the potential to significantly expand global access to CAR-T cell therapy.

P1, N=35, Recruiting, Sana Biotechnology | Initiation date: Oct 2024 --> Apr 2024

Myeloablative conditioning with cyclophosphamide and total body irradiation precede infusion of investigational Orca-T, which consists of infusions of HSPCs and Tregs on Day 0 and an infusion of T conventional (Tcon) cells on Day 2. This paradigm shifting combination of allogeneic CAR T and allo-HCT resulted in 100% MRD- CR with full donor chimerism but without GVHD or severe CAR-mediated toxicity. These data, which demonstrate antigen-specific anti-tumor benefit of allogeneic CAR T cells in combination with GVHD prophylaxis mediated by Tregs and tacrolimus, have potential implications that could benefit patients with other hematologic diseases.

P1, N=133, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Jun 2040 --> Oct 2024

P1, N=41, Recruiting, University of Pennsylvania | N=15 --> 41

P1, N=34, Not yet recruiting, Wuhan Union Hospital, China

P1, N=24, Not yet recruiting, British Columbia Cancer Agency | Initiation date: Jul 2024 --> Nov 2024

P2, N=28, Completed, 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

Our results support the development of CAR-T-cell therapy for R/R CNSL. With the durability of remission and low toxicity, ASCT combined with CAR-T-cell therapy appears to be a more effective and safer treatment option for primary and secondary R/R CNS lymphoma.

P1, N=35, Recruiting, Sana Biotechnology | Initiation date: May 2024 --> Oct 2024

P1, N=26, Recruiting, University of Colorado, Denver | Not yet recruiting --> Recruiting

P1, N=4, Terminated, Medical College of Wisconsin | All four patients had no in-vivo expansion and no meaningful response to therapy. At this point per FDA guidance we will not be treating more patients.

Our study recommends decitabine consolidation after CD19/CD22 CAR-T therapy as a novel maintenance strategy to improve the survival outcomes of patients with r/r B-ALL.

P1/2, N=40, Recruiting, Cellectis S.A. | Trial primary completion date: Dec 2023 --> Jan 2026

P1, N=26, Not yet recruiting, University of Colorado, Denver

P1/2, N=75, Recruiting, Essen Biotech | Not yet recruiting --> Recruiting | Initiation date: Nov 2024 --> Jul 2024

P1/2, N=35, Recruiting, The First Affiliated Hospital of Soochow University | Trial primary completion date: May 2024 --> Dec 2024

P=N/A, N=104, Recruiting, Shanghai Public Health Clinical Center; Shanghai Public Health Clinical Center | N=34 --> 104

This trial identifies CD22 as an immunotherapeutic target in large B-cell lymphoma and demonstrates the durable clinical activity of CAR22 in patients with disease progression after CAR19 therapy. Although these findings are promising, it is essential to recognise that this is a phase 1 dose-finding study. Further investigations are warranted to establish the long-term efficacy and to delineate the patient subgroups that will derive the most benefit from this therapeutic approach.

No abstract available

P1, N=48, Recruiting, Rong Tao

P1, N=38, Active, not recruiting, University College, London | Trial completion date: Jan 2032 --> Dec 2036 | Trial primary completion date: Jan 2024 --> Dec 2028

P1, N=20, Recruiting, Stanford University | Not yet recruiting --> Recruiting

P1, N=36, Recruiting, Sumithira Vasu | Trial completion date: Dec 2024 --> Jul 2026 | Trial primary completion date: Dec 2024 --> Apr 2025

P1, N=20, Active, not recruiting, Institute of Hematology & Blood Diseases Hospital, China | Recruiting --> Active, not recruiting | N=34 --> 20

P1, N=20, Not yet recruiting, Stanford University

P1, N=35, Recruiting, Sana Biotechnology | Not yet recruiting --> Recruiting

In a univariate analysis, there were ten factors associated with infection, including tumor load, lymphodepleting chemotherapy, neutrophil deficiency and lymphocyte reduction, cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), etc. In a multivariate analysis, CRS ≥ grade 3 was identified as a risk factor for infection (hazard ratio = 2.41, 95% confidence interval: 1.08-5.36, P = 0.031). Therefore, actively reducing the CRS grade may decrease the risk of infection and improve the long-term quality of life of these patients.

pH has potential to serve as an informative factor in predicting CAR T-cell quality and clinical outcomes. Thus, its active monitoring during manufacturing may ensure a more effective CAR T-cell product.

No abstract available

P=N/A, N=353, Recruiting, Beijing GoBroad Hospital | Not yet recruiting --> Recruiting

P1/2, N=42, Recruiting, Seattle Children's Hospital | Trial completion date: Feb 2039 --> Feb 2040 | Trial primary completion date: Jun 2024 --> Jun 2025

P=N/A, N=353, Not yet recruiting, Beijing GoBroad Hospital

P1, N=120, Recruiting, Stanford University | Not yet recruiting --> Recruiting

P1, N=120, Not yet recruiting, Stanford University

Duration of response was overall limited (median 77 days), and CD22 expression was downregulated in 4/12 (33%) available samples at relapse. In summary, we demonstrate that closed-loop manufacturing of CD22-CAR T cells is feasible and is associated with a favorable safety profile and high CR rates in pediatric and adult r/r B-ALL, a cohort with limited CD22-CAR reporting.

P1/2, N=50, Not yet recruiting, Juventas Cell Therapy Ltd. | Initiation date: Oct 2023 --> Aug 2024

P1/2, N=80, Not yet recruiting, Juventas Cell Therapy Ltd. | Initiation date: Oct 2023 --> Aug 2024

P1, N=36, Recruiting, Sumithira Vasu | Trial primary completion date: Dec 2023 --> Dec 2024

P1, N=52, Active, not recruiting, Stanford University | Trial completion date: Dec 2024 --> Dec 2037