trovocabtagene autoleucel (C-CAR088) / AbelZeta Pharma - LARVOL DELTA

Efficacy and Safety of Chimeric Antigen Receptor T-Cell Therapy in Relapsed and Refractory Multiple Myeloma – a Meta-Analysis (ASH 2024) - "We included 7 trials each of Ciltacabtagene autoleucel (cilta-cel) and Idecabtagene vicleucel (ida-cel) while 21 trials used different CAR-T cell therapies including GPRC5D, HDS269B, C-CAR088, HBI0101, CART-ddBCMA, ALLO-715, ARI0002h. This analysis has limitations with significant heterogeneity among studies. There were different CAR T-cell therapies with diverse designs of studies which limit the generalization of results."

CAR T-Cell Therapy • Retrospective data • Anemia • Bone Marrow Transplantation • Cardiovascular • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukopenia • Multiple Myeloma • Neutropenia • Oncology • Thrombocytopenia

Promising Safety and Efficacy of Trovocabtagene Autoleucel (C-CAR088) Followed ASCT in Ultra High-Risk Multiple Myeloma (UHR-MM) Patients (ASH 2024) - P1/2 | "Seven patients received melphalan and 5 received fludarabine combining melphalan conditioning...Nine patients (75%) had received daratumumab, with six had been treated with dara-based quadruplet or quintuplet therapy...Phase 1 study of C-CAR088, a novel humanized anti-BCMA CAR T-cell therapy in relapsed/ refractory multiple myeloma. Journal for ImmunoTherapy of Cancer 2022; 10 : e005145."

Clinical • IO biomarker • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Multiple Myeloma • Oncology • Pneumonia • Respiratory Diseases • TP53

A Phase Ib/II Study of Trovocabtagene Autoleucel (C-CAR088), an Anti-BCMA CAR T-Cell Therapy in Relapsed or Refractory Multiple Myeloma (ASH 2024) - P1/2 | "Here, we present the results of the phase Ib part of this study.Methods : R/R MM patients who have been treated with ≥ 3 prior lines of therapy (LOT), including at least one proteasome inhibitor (PIs) and one immunomodulatory drug (IMiDs) were eligible.Total 12 subjects received lymphodepletion with fludarabine (30 mg/m²/day) and cyclophosphamide (300 mg/m²/day) for 3 days, followed by a single infusion of trovo-cel...With a median of 4 prior LOT, all subjects had been exposed to PIs and IMiDs, 91.7% had been treated with daratumumab, 41.7% were penta-exposed and 41.7% had undergone ASCT...No significant differences were observed between the two dose cohorts.Conclusion : Trovo-cel has a manageable safety profile, with no neurotoxicity event and low SPM rate. Deep and durable responses were observed in both dose cohort and 6.0x106 cells/kg reached a relatively higher CR rate."

CAR T-Cell Therapy • P1/2 data • Anemia • Hematological Disorders • Hematological Malignancies • Hypotension • Infectious Disease • Leukemia • Lung Adenocarcinoma • Lung Cancer • Multiple Myeloma • Non Small Cell Lung Cancer • Oncology • Pneumonia • Respiratory Diseases • Septic Shock • Solid Tumor

Promising Safety and Efficacy of Trovocabtagene Autoleucel (C-CAR088) Followed ASCT in Ultra High-Risk Multiple Myeloma (UHR-MM) Patients Who Failed or Had Suboptimal Response to Standard First Line Triplet Based Therapy (ASH 2023) - P1/2 | "Patients undergo conditioning (melphalan alone or plus fludarabine) followed by ASCT on Day 0 and trovo-cel 3...5%) had received daratumumab, with six having been treated with dara-based quadruplet or quintuplet therapy as a front setting...6%) received tocilizumab and glucocorticoid for CRS... The preliminary results of this clinical trial show a promising safety and efficacy profile of trovo-cel followed ASCT in UHR-MM patients. Although the follow-up time is relatively limited, we are looking forward to a consistently good safety and efficacy outcome in long-term follow-up and in more patients recruited later."

Clinical • IO biomarker • Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation • TP53

A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=92 | Recruiting | Sponsor: Cellular Biomedicine Group Ltd. | Initiation date: Aug 2022 ➔ Nov 2022

CAR T-Cell Therapy • Trial initiation date • Hematological Malignancies • Multiple Myeloma • Oncology

[VIRTUAL] An Anti-Bcma CAR T-Cell Therapy (C-CAR088) Shows Promising Safety and Efficacy Profile in Relapsed or Refractory Multiple Myeloma (ASH 2020) - P1 | "C-CAR088 is administered to patients as a single intravenous dose after a standard 3-day cyclophosphamide/fludarabine conditioning regimen...Four patients (19%) received tocilizumab for CRS treatment... The clinical trial results in patients with R/R MM treated with C-CAR088 show a favorable safety profile and promising signs of efficacy. We will continue to evaluate these patients to understand the long-term effect of C-CAR088 in multiple myeloma patients. Clinical trial information: NCT04322292、NCT03815383、NCT03751293、NCT04295018 Research Sponsor: Cellular Biomedicine Group, Inc."

CAR T-Cell Therapy • Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

ASCT in Combination With C-CAR088 for Treating Patients With Ultra High-risk Multiple Myeloma (MM) (clinicaltrials.gov) - P1/2 | N=20 | Recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital

CAR T-Cell Therapy • Combination therapy • New P1/2 trial • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Updated Phase 1 Results of C-CAR088, an Anti-BCMA CAR T-Cell Therapy in Relapsed or Refractory Multiple Myeloma (ASH 2021) - P1 | "C-CAR088 was administered to patients as a single infusion after lymphodepletion with fludarabine (30 mg/m 2 ) and cyclophosphamide (300 mg/m 2 ) daily for 3 days...9/31 (29%) patients used tocilizumab and 6/31 (19.4%) patients used corticosteroids to manage CRS... C-CAR088 has a manageable safety profile, which includes low neurotoxicity rates (with no gr ≥3 events). Deep and durable responses were observed in ≥ 3.0x10 6 CAR-T cells/kg cohorts. Doses of 3.0 and 6.0×10 6 CAR T cells/kg were selected for further study."

CAR T-Cell Therapy • P1 data • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology • Septic Shock

Phase 1 study of C-CAR088, a novel humanized anti-BCMA CAR T-cell therapy in relapsed/refractory multiple myeloma. (PubMed, J Immunother Cancer) - P1 | "The present study demonstrated that C-CAR088 had a good safety profile and high antitumor activity in patients with RRMM, constituting a promising treatment option for RRMM."

CAR T-Cell Therapy • IO biomarker • Journal • P1 data • Hematological Disorders • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology

A Study of C-CAR088 in Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=92 | Recruiting | Sponsor: Cellular Biomedicine Group Ltd.

CAR T-Cell Therapy • New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

A PHASE I STUDY OF C-CAR088, A NOVEL HUMANIZED ANTI-BCMA CAR T CELL THERAPY IN RELAPSED/REFRACTORY MULTIPLE MYELOMA (EHA 2022) - "The CR rate in the medium-dose (3.0 × 10 6 CAR T cells/kg) and high-dose (4.5-6.0 × 10 6 CAR T cells/kg) groups was 54.5% and 71.4%, respectively. In the CR group, 15 (93.7%) patients achieved minimal residual disease (MRD) negativity (test sensitivity >1/10 -5 ). All seven patients with double-hit or triple-hit multiple myeloma achieved MRD-negative CR. Conclusion Our findings demonstrate the manageable safety profile and potential efficacy of C-CAR088."

CAR T-Cell Therapy • P1 data • Hematological Malignancies • Inflammation • Multiple Myeloma • Oncology

CBMG Holdings Completes $120 Million in Series A Funding, Accelerating Development of CAR-T Therapy Pipelines and R&D for Innovative Solid Tumor Therapies (PRNewswire) - "This round of financing will largely be used to accelerate the clinical development of the Company's immune-oncology platform. Specifically, C-CAR039, an anti-CD19/CD20 bispecific CAR-T therapy for the treatment of patients with relapsed or refractory non-Hodgkin lymphoma (r/r NHL) and C-CAR088, a B cell maturation antigen (BCMA) therapy for patients with late-stage relapsed/refractory (r/r) multiple myeloma (MM), as well as armored CAR-T therapies and tumor-infiltrating lymphocytes (TIL) therapies targeting solid tumors."

Commercial • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

Developing a Novel Anti-Bcma CAR-T for Relapsed or Refractory Multiple Myeloma (ASH 2019) - P1; "C-CAR088 is then manufactured and administered to patients as a single intravenous dose after a standard 3-day cyclophosphamide/fludarabine conditioning regimen. In conclusion, early clinical trial results in patients with r/r MM for C-CAR088 support preclinical findings that the drug shows promising efficacy and manageable safety profile.The very early clinical efficacy signal at low, suboptimal dose is encouraging and compares favorably to many other anti-BCMA CAR-T products at similar dose. The promising trend needs to be confirmed by the ongoing clinical trial."

Hematological Disorders • Hematological Malignancies • Multiple Myeloma • Oncology

"CCAR088 CAR-T -2nd generation CAR-T #ASH20 #MMSM #Myeloma #IMFASH20" (@MyelomaTeacher)

Hematological Malignancies • Multiple Myeloma • Oncology

Cellular Biomedicine Group Announces Data to be Presented at 2020 ASH Annual Meeting (PRNewswire) - "Cellular Biomedicine Group Inc...announced....that three abstracts relating to its immuno-oncology drug development have been accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition to be held as a virtual event on December 5-8, 2020."

Clinical data • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Cellular Biomedicine Group Reports Q3 2020 Financial Results and Business Highlights (PRNewswire) - "Regarding our C-CAR088 anti-BCMA drug development for multiple myeloma (MM), to date we have infused 26 of the 28 patients enrolled in the IIT study in China. Our abstract for this study has been accepted for an oral presentation on Saturday, December 5, 2020, 1:15pm at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition."

P1 data • Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

Cellular Biomedicine Group (CBMG) Reports Q2, H1 2020 Financial Results and Business Highlights (PRNewswire) - "We plan to submit and present the C-CAR088 and C-CAR039 clinical data at a major conference later this year...Upcoming Milestones: In 2021, execute our C-TIL051 to sponsor and initiate an IIT in the U.S. for stage IIIB and IV NSCLC patients refractory to anti-PD1 immunotherapy."

Clinical data • New trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Cellular Biomedicine Group reports Q1 2020 financial results and business highlights (PRNewswire) - "First quarter 2020 and other recent corporate developments: (1) Anti-BCMA CAR-T for Relapsed or Refractory Multiple Myeloma: National Medical Products Administration of China (NMPA) accepted our IND application for Phase I clinical trial; 19 patients have been infused under investigator-initiated studies; 17 patients have evaluable data for clinical efficacy with only one grade 3 CRS observed; (2) Anti-CD19/CD20 Bi-Specific CAR-T for Non-Hodgkin's Lymphoma: 4 patients have been infused under investigator-initiated studies; 3 patients have evaluable data for clinical efficacy."

Non-US regulatory • P1 data • Trial status • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma (clinicaltrials.gov) - P1; N=10; Recruiting; Sponsor: Institute of Hematology & Blood Diseases Hospital

New P1 trial

A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma (clinicaltrials.gov) - P1; N=10; Recruiting; Sponsor: Peking Union Medical College Hospital

Clinical • New P1 trial

Cellular Biomedicine Group presents first clinical data of IIT phase 1 trial of C-CAR088, a novel BCMA CAR-T, at the 61st Annual Meeting of the American Society of Hematology (PRNewswire) - P1, N=10; NCT03751293; "A Phase 1, dose escalation trial is being conducted in patients with relapsed or refractory Multiple Myeloma ('r/r MM') to assess the safety and efficacy of C-CAR088. All five patients showed clinical improvement as early as two weeks post treatment. By 4 weeks, one patient achieved a complete response ('CR'), three patients reached a very good partial response ('VGPR')....C-CAR088 proliferation & expansion in the peripheral blood correlated with the decrease of tumor burden in all patients. C-CAR088 treatment showed to be well tolerated. There were no dose-limiting toxicities ('DLTs')."

P1 data

A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: The First Affiliated Hospital with Nanjing Medical University; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma (clinicaltrials.gov) - P1; N=10; Recruiting; Sponsor: Hebei Yanda Ludaopei Hospital; Not yet recruiting ➔ Recruiting; Trial completion date: Jul 2020 ➔ Oct 2020; Trial primary completion date: Jul 2019 ➔ Oct 2019

Clinical • Enrollment open • Trial completion date • Trial primary completion date