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- ||||| Enrollment change: Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells (clinicaltrials.gov) - Dec 26, 2024
P=N/A, N=1000, Enrolling by invitation, Sponsor: Kite, A Gilead Company
N=700 --> 1000
- Efficacy and Safety of Chimeric Antigen Receptor T-Cell Therapy in Relapsed and Refractory Multiple Myeloma (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_5439;
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.
- anitocabtagene autoleucel (CART-ddBCMA) / Arcellx, Gilead
Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma (RRMM): Efficacy and Safety with 34-Month Median Follow-up (Halls G-H (San Diego Convention Center)) - Nov 6, 2024 - Abstract #ASH2024ASH_3842;
P2, P3
Follow-up is continuing and updated data will be presented. Further investigations of anito-cel are ongoing in 4L+ RRMM (iMMagine-1, NCT05396885) and in earlier lines (iMMagine-3, NCT06413498).
- anitocabtagene autoleucel (CART-ddBCMA) / Arcellx, Gilead
Phase 2 Registrational Study of Anitocabtagene Autoleucel for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma: Preliminary Results from the IMMagine-1 Trial (Pacific Ballroom Salons 24-26 (Marriott Marquis San Diego Marina)) - Nov 6, 2024 - Abstract #ASH2024ASH_2118;
P2
Further investigations of anito-cel are ongoing in 4L+ RRMM (iMMagine-1, NCT05396885) and in earlier lines (iMMagine-3, NCT06413498). Following leukapheresis, optional bridging, and anito-cel manufacturing, pts received lymphodepletion chemotherapy (fludarabine 30 mg/m2/d and cyclophosphamide 300 mg/m2/d for 3 days) and a single infusion of anito-cel (target dose of 115
- || anitocabtagene autoleucel (CART-ddBCMA) / Arcellx, Gilead
New P1 trial: A Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Subjects With Non-oncology Plasma Cell-related Diseases (clinicaltrials.gov) - Oct 4, 2024
P1, N=30, Not yet recruiting, Sponsor: Arcellx, Inc.
- anitocabtagene autoleucel (CART-ddBCMA) / Arcellx, Gilead
iMMagine-3: A Phase 3, Randomized Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel (Anito-Cel) With Standard of Care in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) (LEVEL 3, HALL B3) - Aug 30, 2024 - Abstract #SOHO2024SOHO_895;
P3
Before randomization, investigators will select a SOC regimen: pomalidomide, bortezomib, and dexamethasone; daratumumab, pomalidomide, and dexamethasone; carfilzomib, daratumumab, and dexamethasone; or carfilzomib and dexamethasone. iMMagine-3 is enrolling soon.
- anitocabtagene autoleucel (CART-ddBCMA) / Arcellx, Gilead
Phase 1 Study of Anitocabtagene Autoleucel for the Treatment of Patients With Relapsed and/or Refractory Multiple Myeloma: Results From at Least 1-Year Follow-Up in all Patients (LEVEL 3, HALL B3) - Aug 30, 2024 - Abstract #SOHO2024SOHO_892;
Efficacy analyses demonstrated 100% ORR, with 76% ?CR. Responses were durable with an estimated 24-month PFS rate of 56% and comparable outcomes in patients with high-risk disease.
- |||||| anitocabtagene autoleucel (CART-ddBCMA) / Arcellx, Gilead
Enrollment open: iMMagine-3: A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma (clinicaltrials.gov) - Aug 22, 2024
P3, N=450, Recruiting, Sponsor: Kite, A Gilead Company
Responses were durable with an estimated 24-month PFS rate of 56% and comparable outcomes in patients with high-risk disease. Not yet recruiting --> Recruiting
- || Enrollment closed, Enrollment change: ARC-101: Study of Anitocabtagene-autoleucel in Participants With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov) - Jul 17, 2024
P1, N=40, Active, not recruiting, Sponsor: Kite, A Gilead Company
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | N=65 --> 40
- |||||||||| anitocabtagene autoleucel (CART-ddBCMA) / Arcellx, Gilead
New P3 trial: iMMagine-3: A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma (clinicaltrials.gov) - May 14, 2024
P3, N=450, Not yet recruiting, Sponsor: Kite, A Gilead Company
- || Trial completion date, Trial primary completion date: Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells (clinicaltrials.gov) - Apr 11, 2024
P2, N=700, Enrolling by invitation, Sponsor: Kite, A Gilead Company
Recruiting --> Active, not recruiting | N=65 --> 40 Trial completion date: Mar 2041 --> Dec 2040 | Trial primary completion date: Mar 2041 --> Dec 2040
- anitocabtagene autoleucel (CART-ddBCMA) / Arcellx, Gilead
Phase 1 Study of CART-Ddbcma for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma: Results from at Least 1-Year Follow-up in All Patients (Room 6A (San Diego Convention Center)) - Nov 3, 2023 - Abstract #ASH2023ASH_5207;
Ongoing efficacy results are encouraging, with 100% ORR, including 35 (92%) response of VGPR or better & 29 (76%) with CR/sCR. More importantly, clinical responses were durable with an overall estimated 18-mo PFS rate of 67% with comparable clinical responses seen in 'high-risk' patients known to have poor prognosis.
- || Trial completion date, Trial primary completion date: Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells (clinicaltrials.gov) - Jul 14, 2023
P2, N=700, Enrolling by invitation, Sponsor: Kite, A Gilead Company
More importantly, clinical responses were durable with an overall estimated 18-mo PFS rate of 67% with comparable clinical responses seen in 'high-risk' patients known to have poor prognosis. Trial completion date: Nov 2026 --> Mar 2041 | Trial primary completion date: Nov 2026 --> Mar 2041
- || Trial primary completion date: ARC-101: Study of Anitocabtagene-autoleucel in Participants With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov) - Jul 12, 2023
P1, N=65, Recruiting, Sponsor: Arcellx, Inc.
Trial completion date: Nov 2026 --> Mar 2041 | Trial primary completion date: Nov 2026 --> Mar 2041 Trial primary completion date: Aug 2022 --> Aug 2024
- ||||| CART-ddBCMA / Arcellx, Gilead
I hadn't noticed CART-ddBCMA visual abstract until just now! I'd always emphasized its provenance (e.g., engineered to ⬇️ ADAs)... ... But also look at how tiny it is compared to other CARs! Maybe less steric hindrance could mean more #MMsm killing? https://t.co/SqooVAH6a0 https://t.co/gXA112JeQ7 (Twitter) - Mar 20, 2023
- ||||| CART-ddBCMA / Arcellx, Gilead
I hadn't noticed CART-ddBCMA visual abstract until just now! I'd always emphasized its provenance (e.g., engineered to ⬇️ ADAs)... ... But also look at how tiny it is compared to other CARs! Maybe less steric hindrance could mean more #MMsm killing? https://t.co/SqooVAH6a0 (Twitter) - Mar 20, 2023
- |||| CART-ddBCMA / Arcellx, Gilead
Phase 1 study of CART-ddBCMA for the treatment of subjects with relapsed and refractory multiple myeloma https://t.co/fVSnmmVZS1 (Twitter) - Mar 17, 2023
- || CART-ddBCMA / Arcellx, Gilead
P1 data, Journal: Phase 1 Study of CART-ddBCMA for the treatment of subjects with relapsed and refractory multiple myeloma. (Pubmed Central) - Mar 6, 2023
P1
Responses deepened over time and at the time of last data-cut (median follow-up 56 weeks), 8/9 (89%) of evaluable patients achieved minimal residual disease negativity. In conclusion, the findings demonstrate the safety of CART-ddBCMA cells and document durable responses to CART-ddBCMA in RRMM patients.
- Infectious Complications in Patients Following B-Cell Maturation Antigen – Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Multiple Myeloma () - Dec 16, 2022 - Abstract #TCTASTCTCIBMTR2023TCT_ASTCT_CIBMTR_896;
Infections following BCMA CAR T-cell therapy have previously been reported in small cohorts, often involving multiple IEC targets. This study describes the largest cohort to date with IEC products targeting the BCMA antigen and provides additional clarity on the characteristics of early and late infections after BCMA CAR T-cell therapy.
- ||| anitocabtagene autoleucel (CART-ddBCMA) / Arcellx, Gilead
Enrollment open: Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1) (clinicaltrials.gov) - Dec 7, 2022
P2, N=110, Recruiting, Sponsor: Arcellx, Inc.
This study describes the largest cohort to date with IEC products targeting the BCMA antigen and provides additional clarity on the characteristics of early and late infections after BCMA CAR T-cell therapy. Not yet recruiting --> Recruiting
- CART-ddBCMA / Arcellx, Gilead
Phase 1 Study of CART-Ddbcma for the Treatment of Subjects with Relapsed and /or Refractory Multiple Myeloma (Hall D (Ernest N. Morial Convention Center)) - Nov 4, 2022 - Abstract #ASH2022ASH_4694;
Ongoing efficacy results are encouraging, with 100% ORR, including 29 (94%) demonstrating deep clinical responses of ≥VGPR and 22 (71%) with CR/sCR. At the time of the meeting, updated data will be presented.
- |||| CART-ddBCMA / Arcellx
CART-ddBCMA Generates Deep Responses in Relapsed/Refractory Multiple Myeloma https://t.co/wWxBQTXBDT via @onclive (Twitter) - Sep 14, 2022
- CART-ddBCMA / Arcellx
CART-ddBCMA for multiple myeloma: Interim results from phase I study (7.3.Q - Quimper Auditorium) - Jul 25, 2022 - Abstract #ESMO2022ESMO_1531;
P1
Median duration of response, PFS & OS were not evaluable at the time of data-cut because 19 of 24 evaluable pts (79%) remain in ongoing response. Conclusions CART-ddBCMA has demonstrated clinical activity, including 100% ORR & durable responses.
- CART-ddBCMA / Arcellx
Phase 1 Study of CART-ddBCMA, a CAR-T Therapy Utilizing a Novel Synthetic Binding Domain for the Treatment of Subjects with Relapsed and Refractory Multiple Myeloma (Petree Hall C) - Jul 21, 2022 - Abstract #IMW2022IMW_180;
CART-ddBCMA has demonstrated clinical activity, including 100% ORR with rates of CR/sCR and ≥VGPR of 71% and 94%, respectively. No off-tumor tissue-targeted toxicity or delayed neurotoxicity or Parkinson’s-like events were observed in the entire cohort.
- | CART-ddBCMA / Arcellx
Preclinical, Journal, CAR T-Cell Therapy: Preclinical Efficacy of BCMA-Directed CAR T Cells Incorporating a Novel D Domain Antigen Recognition Domain. (Pubmed Central) - Jul 9, 2022
P1
Furthermore, ddBCMA CAR T cells demonstrated in vivo tumor suppression in three disseminated BCMA-expressing tumor models in NSG-immunocompromised mice. On the basis of these promising preclinical data, CART-ddBCMA is being studied in a first-in-human phase I clinical study to assess the safety, pharmacokinetics, immunogenicity, efficacy, and duration of effect for patients with RRMM (NCT04155749).
- ||||||| CART-ddBCMA / Arcellx
Clinical: Double dipping! CART-ddBCMA: novel smaller binding domain to decrease immunogenicity, n= 31. 100% ORR! 94% VGPR or better; 69% of pts with 12 m FU still in response; CRS 88-100%, ICANS acceptable. Congrats to @MJFzeta and #mmsm #ASCO22 (Twitter) - Jun 5, 2022
- |||| anitocabtagene autoleucel (CART-ddBCMA) / Arcellx, Gilead
New P2 trial: Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1) (clinicaltrials.gov) - May 30, 2022
P2, N=100, Not yet recruiting, Sponsor: Arcellx, Inc.
- |||||| CART-ddBCMA / Arcellx
CAR T-Cell Therapy: #ASCO22 Phase 1 study of CART-ddBCMA (autologous CAR-T, utilizes a synthetic binding domain, instead of a typical scFv) in rel/ref MM. N=24, ORR 100%, sCR 67%. 1/24 gr 3 CRS, 4/24 ICANS #mmsm #CARTcell #bmtsm @MJFzeta https://t.co/0TQlKIiD4R (Twitter) - May 30, 2022
- CART-ddBCMA / Arcellx
Phase 1 study of CART-ddBCMA in relapsed or refractory multiple myeloma. (Available On Demand) - Apr 28, 2022 - Abstract #ASCO2022ASCO_4127;
P1
CART-ddBCMA administration, to date, has demonstrated clinical activity, including 100% ORR with rates of CR/sCR and ≥VGPR of 67% and 88%, respectively. Durable responses beyond 18 months have been observed, including in pts with EMD.
- || Enrollment change, Trial primary completion date: ARC-101: Study of Anitocabtagene-autoleucel in Participants With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov) - Feb 10, 2022
P1, N=65, Recruiting, Sponsor: Arcellx, Inc.
Durable responses beyond 18 months have been observed, including in pts with EMD. N=12 --> 65 | Trial primary completion date: Nov 2021 --> Aug 2022
- |||| Enrollment open: Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells (clinicaltrials.gov) - Nov 26, 2021
P2, N=700, Enrolling by invitation, Sponsor: Kite, A Gilead Company
N=12 --> 65 | Trial primary completion date: Nov 2021 --> Aug 2022 Not yet recruiting --> Enrolling by invitation
- CART-ddBCMA / Arcellx, Actemra IV (tocilizumab) / Roche, JW Pharma
Phase 1 Study of CART-Ddbcma, a CAR-T Therapy Utilizing a Novel Synthetic Binding Domain for the Treatment of Subjects with Relapsed and /or Refractory Multiple Myeloma (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_5530;
Of those evaluable (n=12), all subjects, but one, have achieved MRD-negative bone marrow responses at 1 month, and demonstration of deeper response has occurred at later timepoints. Dose escalation was completed, and expansion is continuing at DL1.
- ||||| New P2 trial: Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells (clinicaltrials.gov) - Sep 12, 2021
P2, N=700, Not yet recruiting, Sponsor: Kite, A Gilead Company
- | Trial primary completion date: ARC-101: Study of Anitocabtagene-autoleucel in Participants With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov) - May 19, 2021
P1, N=12, Recruiting, Sponsor: Arcellx, Inc.
Dose escalation was completed, and expansion is continuing at DL1. Trial primary completion date: Nov 2020 --> Nov 2021
- CART-ddBCMA / Arcellx
[VIRTUAL] Design and Demonstration of Potent In Vitro and In Vivo Activity for CART-ddBCMA, a BCMA-Targeted CAR-T Cell Therapy Incorporating a Non-scFv Binding Domain () - Apr 30, 2021 - Abstract #ASGCT2021ASGCT_115;
P1
The level of CART-ddBCMA cells detected in circulation 14 days post-T cell transfer was dependent on the initial dose, and at each dose CAR expression was maintained in 90+% of hCD3+ T cells. Based on these promising preclinical data CART-ddBCMA is being studied in a first-in-human phase I clinical study to assess the safety, pharmacokinetics, immunogenicity, efficacy, and duration of effect for patients with RRMM (NCT04155749).
- Actemra IV (tocilizumab) / Roche, JW Pharma
[VIRTUAL] Phase 1 Study of CART-ddBCMA, a CAR-T therapy utilizing a novel synthetic binding domain, for the treatment of subjects with relapsed and refractory multiple myeloma. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2869;
P1
8/9 responses are ongoing and responses continue to deepen . These data are encouraging in high-risk subjects with penta-refractory myeloma .
- Actemra IV (tocilizumab) / Roche, JW Pharma
[VIRTUAL] Phase 1 Study of CART-Ddbcma, a CAR-T Therapy Utilizing a Novel Synthetic Binding Domain for the Treatment of Subjects with Relapsed and Refractory Multiple Myeloma (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_3997;
P1
Subjects undergo lymphodepletion with fludarabine (30 mg/m2) and cyclophosphamide (300 mg/m2) daily for 3 days, then receive CART-ddBCMA as a single infusion...These adverse effects resolved quickly after intervention; 3 subjects received tocilizumab and 2 received steroids (dexamethasone)...Subjects continue to be enrolled and treated. Additional subjects, and longer follow-up will establish whether treatment with CART-ddBCMA results in durable CAR+ T responses.
- | New P1 trial: ARC-101: Study of Anitocabtagene-autoleucel in Participants With Relapsed Refractory Multiple Myeloma (clinicaltrials.gov) - Nov 14, 2019
P1, N=12, Recruiting, Sponsor: Arcellx, Inc.