Evidence map›Paper›PMID 36200421›Full record

ArticleHaematologica2023

Development and manufacture of novel locally produced anti-BCMA CAR T cells for the treatment of relapsed/refractory multiple myeloma: results from a phase I clinical trial.

Nathalie Asherie, Shlomit Kfir-Erenfeld, Batia Avni, Miri Assayag, Tatyana Dubnikov, Nomi Zalcman, Eyal Lebel, Eran Zimran, Adir Shaulov, Marjorie Pick and 6 more

4 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Haematologica, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 23 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 4 pooled it
2.7field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04720313 phase1active not recruitingnot on this map

A Phase 1 Dose Escalation and Safety Study of NXC-201 (formerly HBI0101) CART in BCMA-Expressing Multiple Myeloma Patients

TypeinterventionalSponsorHadassah Medical OrganizationRan2021 to 2027Enrolled160ConditionsDose Escalation and SafetyArmsNXC-201 (formerly HBI0101)
NCT06097832 phase1 / phase2active not recruitingnot on this mapstarted 2024, after this paper: background citation

Phase 1b/2 Study of NXC-201 for the Treatment of Patients With Relapsed or Refractory AL Amyloidosis

TypeinterventionalSponsorNexcella Inc.Ran2024 to 2039Enrolled45ConditionsLight Chain (AL) AmyloidosisArmsNXC-201 CAR-T
NCT06971380 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

A Phase 2 Trial to Study Efficacy and Safety of HBI0101 (NXC-201) CART in Subjects With Multiple Myeloma and Light-Chain Amyloidosis.

TypeinterventionalSponsorPolina StepenskyRan2025 to 2030Enrolled180ConditionsMultiple Myeloma, Refractory to Standard Treatment, Multiple Myeloma, Relapsed, Light Chain AmyloidosisArmsHBI0101 CART
NCT07085676 phase1recruitingnot on this mapstarted 2024, after this paper: background citation

A Phase 1 Dose Escalation and Safety Study of HBI0101 CART in B-cell Mediated Refractory Autoimmune Diseases

TypeinterventionalSponsorPolina StepenskyRan2024 to 2030Enrolled120ConditionsSystemic Sclerosis (SSc), Idiopathic Inflammatory Myopathy (IIM), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)ArmsHBI0101 CART
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 27 citations in OpenAlex.

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  16. Current Novel Targeted Therapeutic Strategies in Multiple Myeloma.International journal of molecular sciences · 2024
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 4 institutions in 1 country.

Nathalie AsherieDepartment of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem. nathaliea@hadassah.org.il.
Shlomit Kfir-ErenfeldDepartment of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem.
Batia AvniDepartment of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem.
Miri AssayagDepartment of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem.
Tatyana DubnikovDepartment of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem.
Nomi ZalcmanDepartment of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem.
Eyal LebelDepartment of Hematology, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem.
Eran ZimranDepartment of Hematology, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem.
Adir ShaulovDepartment of Hematology, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem.
Marjorie PickDepartment of Hematology, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem.
Yael CohenDepartment of Hematology, Aviv Medical Center, Sackler faculty of medicine, Aviv University.
Irit AviviDepartment of Hematology, Aviv Medical Center, Sackler faculty of medicine, Aviv University.
Cyrille CohenLaboratory of Tumor Immunology and Immunotherapy, The Mina and Everard Goodman Faculty of Life Sciences, Bar-Ilan University, Ramat Gan 52900-02, Israel.
Moshe E GattDepartment of Hematology, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem.
Sigal GrisariuDepartment of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem.
Polina StepenskyDepartment of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Center, Faculty of Medicine, Hebrew University of Jerusalem. polina@hadassah.org.il.
Hadassah Medical Center · ILHebrew University of Jerusalem · ILTel Aviv University · ILBar-Ilan University · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor T-cell (CAR T) therapy shows remarkable efficacy in patients with relapsed and/or refractory (R/R) multiple myeloma (MM). HBI0101, a novel second generation optimized anti- BCMA CAR T-cell therapy, was developed in an academic setting. We conducted a phase I dose-escalation study of HBI0101 (cohort 1: 150x106 CAR T cells, n=6; cohort 2: 450x106 CAR T cells, n=7; cohort 3: 800x106 CAR T cells, n=7) in 20 heavily pre-treated R/R MM patients. Grade 1-2 cytokine release syndrome (CRS) was reported in 18 patients (90%). Neither grade 3-4 CRS nor neurotoxicity of any grade were observed. No dose-limiting toxicities were observed in any cohort. The overall response rate (ORR), (stringent) complete response (CR/sCR), and very good partial response rates were 75%, 50%, and 25%, respectively. Response rates were dose-dependent with 85% ORR, 71% CR, and 57% minimal residual disease negativity in the high-dose cohort 3. Across all cohorts, the median overall survival (OS) was 308 days (range 25-466+), with an estimated OS of 55% as of June 27th (data cut-off). The median progression-free survival was 160 days, with 6 subjects remaining progression free at the time of data cut-off. Our findings demonstrate the manageable safety profile and efficacy of HBI0101. These encouraging data support the decentralization of CAR T production in an academic setting, ensuring sufficient CAR T supply to satisfy the increasing local demand. Clinicaltrials.gov NCT04720313.

Indexed as

Multiple MyelomaReceptors, Chimeric AntigenAntibodiesHumansImmunotherapy, AdoptiveT-LymphocytesAntibodiesReceptors, Chimeric Antigen

Identifiers

PMID36200421
PMCPMC10316256
OpenAlexW4302287875

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.