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Trials |  |
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- || REGN5459 / Regeneron, linvoseltamab (REGN5458) / Regeneron, Sanofi
Trial completion date, Trial primary completion date: An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive A Kidney Transplant (clinicaltrials.gov) - Sep 5, 2023
P=N/A, N=12, Recruiting, Sponsor: Regeneron Pharmaceuticals
Trial completion date: Mar 2025 --> May 2026 | Trial primary completion date: Mar 2025 --> May 2026
- | REGN5459 / Regeneron, Sanofi
Trial completion date, Trial primary completion date: First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM) (clinicaltrials.gov) - Jul 10, 2023
P1/2, N=43, Active, not recruiting, Sponsor: Regeneron Pharmaceuticals
Trial completion date: Mar 2025 --> May 2026 | Trial primary completion date: Mar 2025 --> May 2026 Trial completion date: Nov 2023 --> Nov 2025 | Trial primary completion date: Aug 2023 --> Aug 2025
- ||| REGN5459 / Regeneron
Clinical: “REGN5459, a BCMA×CD3 bispecific antibody with low affinity to CD3, showed manageable safety and promising efficacy in heavily pretreated [patients with] relapsed/refractory multiple myeloma,” -@suvannasankha, MD. #mmsm | @IUMedSchool https://t.co/bxWz7sxBkx (Twitter) - Jun 20, 2023
- | REGN5459 / Regeneron
Journal: BCMAxCD3 Bispecific Yields Robust Responses in Myeloma. (Pubmed Central) - Jun 5, 2023
In emerging data from a phase I/II trial, patients with relapsed/refractory multiple myeloma responded well to REGN5459, an investigational BCMA-targeting bispecific T-cell engager. However, despite the drug's low affinity for CD3 on T cells, this design did not mitigate the risk of cytokine release syndrome, a common toxicity.
- ||| REGN5459 / Regeneron, linvoseltamab (REGN5458) / Regeneron, Sanofi
Enrollment open, Trial completion date, Trial primary completion date: An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive A Kidney Transplant (clinicaltrials.gov) - May 17, 2023
P=N/A, N=12, Recruiting, Sponsor: Regeneron Pharmaceuticals
However, despite the drug's low affinity for CD3 on T cells, this design did not mitigate the risk of cytokine release syndrome, a common toxicity. Not yet recruiting --> Recruiting | Trial completion date: May 2026 --> Mar 2025 | Trial primary completion date: May 2026 --> Mar 2025
- ||||| REGN5459 / Regeneron
Clinical, Cytokine release syndrome: REGN5459 led to fast onset, deep, and dose-dependent responses sustained over time, with a high frequency of manageable low-grade cytokine release syndrome in patients with R/R multiple myeloma. @ASuvannasankha @IUCancerCenter #mmsm https://t.co/Jd1TfPqYtc (Twitter) - Apr 26, 2023
- |||| REGN5459 / Regeneron
Clinical, Cytokine release syndrome: REGN5459 led to fast onset, deep, and dose-dependent responses sustained over time, with a high frequency of manageable low-grade cytokine release syndrome in patients with R/R multiple myeloma. @ASuvannasankha @IUCancerCenter #mmsm #AACR23 https://t.co/sfzdoITcpv (Twitter) - Apr 24, 2023
- |||| REGN5459 / Regeneron
P1/2 data: Happening now at #AACR23: Ken Anderson, MD, of @DanaFarber/@harvardmed is discussing implications of the phase I/II study on REGN5459 presented today by @suvannasankha of @IUMedSchool/@IUCancerCenter. (Twitter) - Apr 17, 2023
- ||| REGN5459 / Regeneron
"Further development of this agent, as well as a strategy to modify the CD3 binding affinity—as a way to mitigate CRS in bispecific antibody therapy in myeloma—are promising areas," @suvannasankha of @IUMedSchool/@IUCancerCenter said of REGN5459 during #AACR23. (Twitter) - Apr 17, 2023
- |||| REGN5459 / Regeneron
Clinical: REGN5459 showed "early, durable, deep responses" in pts with relapsed or refractory MM who were heavily pretreated, @suvannasankha said during the #AACR23 press briefing on the study. (Twitter) - Apr 17, 2023
- ||| REGN5459 / Regeneron
Clinical, P1 data: Happening now at #AACR23: @suvannasankha of @IUMedSchool/@IUCancerCenter is discussing a phase I study of REGN5459, a bispecific antibody targeting BCMA and CD3, in pts with relapsed or refractory MM. (Twitter) - Apr 17, 2023
- ||| REGN5459 / Regeneron
REGN5459 Delivers Dose-Dependent Responses in Relapsed/Refractory Myeloma @ASuvannasankha @IUCancerCenter @AACR #mmsm #AACR23 https://t.co/PVTLAN1Euu (Twitter) - Apr 17, 2023
- REGN5459 / Regeneron
Safety and efficacy from the phase 1/2 first-in-human study of REGN5459, a BCMA (W Hall A2-3 - Convention Center) - Mar 14, 2023 - Abstract #AACR2023AACR_4401;
Not yet recruiting --> Recruiting | Trial completion date: May 2026 --> Mar 2025 | Trial primary completion date: May 2026 --> Mar 2025 Abstract is embargoed at this time.
- REGN5459 / Regeneron, linvoseltamab (REGN5458) / Regeneron
A Dose Escalation and Proof-of-Concept Study of REGN5459 or REGN5458 (BCMAxCD3 Bispecific Antibodies) for Desensitization of Hemodialysis Patients Who Are Highly Sensitized to Human Leukocyte Antigen (Exhibit Hall, Orange County Convention Center, West Building) - Oct 15, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_4538;
P=N/A, P1/
Secondary objectives include determining dosing regimen(s) that result in a clinically meaningful reduction of anti-HLA alloantibody levels, the effect on cPRA levels and circulating immunoglobulin isotypes, pharmacokinetics, and immunogenicity. In a companion study (NCT05106387), patients enrolled in NCT05092347 who receive a kidney transplant will be followed for 1 year to assess rates of adverse events, graft survival, rates and classification of rejection, and emergence of anti-HLA alloantibodies.
- REGN5459 / Regeneron, linvoseltamab (REGN5458) / Regeneron
A Dose Escalation and Proof-of-Concept Study of REGN5459 or REGN5458 (BCMAxCD3 Bispecific Antibodies) for Desensitization of Hemodialysis Patients Who Are Highly Sensitized to Human Leukocyte Antigen (Exhibit Hall, Orange County Convention Center, West Building) - Oct 15, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_3886;
P=N/A, P1/
Secondary objectives include determining dosing regimen(s) that result in a clinically meaningful reduction of anti-HLA alloantibody levels, the effect on cPRA levels and circulating immunoglobulin isotypes, pharmacokinetics, and immunogenicity. In a companion study (NCT05106387), patients enrolled in NCT05092347 who receive a kidney transplant will be followed for 1 year to assess rates of adverse events, graft survival, rates and classification of rejection, and emergence of anti-HLA alloantibodies.
- REGN5459 / Regeneron, linvoseltamab (REGN5458) / Regeneron
A Dose Escalation and Proof-of-Concept Study of REGN5459 or REGN5458 (BCMAxCD3 Bispecific Antibodies) for Desensitization of Hemodialysis Patients Who Are Highly Sensitized to Human Leukocyte Antigen (Exhibit Hall, Orange County Convention Center, West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_872;
P=N/A, P1/
Secondary objectives include determining dosing regimen(s) that result in a clinically meaningful reduction of anti-HLA alloantibody levels, the effect on cPRA levels and circulating immunoglobulin isotypes, pharmacokinetics, and immunogenicity. In a companion study (NCT05106387), patients enrolled in NCT05092347 who receive a kidney transplant will be followed for 1 year to assess rates of adverse events, graft survival, rates and classification of rejection, and emergence of anti-HLA alloantibodies.
- ||| REGN5459 / Regeneron, Sanofi, linvoseltamab (REGN5458) / Regeneron, Sanofi
Enrollment open: Study for Desensitization of Chronic Kidney Disease in Adult Patients in Need of a Kidney Transplant Who Are Highly Sensitized to Human Leukocyte Antigen (clinicaltrials.gov) - Aug 19, 2022
P1/2, N=60, Recruiting, Sponsor: Regeneron Pharmaceuticals
In a companion study (NCT05106387), patients enrolled in NCT05092347 who receive a kidney transplant will be followed for 1 year to assess rates of adverse events, graft survival, rates and classification of rejection, and emergence of anti-HLA alloantibodies. Not yet recruiting --> Recruiting
- | REGN5459 / Regeneron, Sanofi
Trial completion date: First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM) (clinicaltrials.gov) - Aug 17, 2022
P1/2, N=43, Active, not recruiting, Sponsor: Regeneron Pharmaceuticals
Not yet recruiting --> Recruiting Trial completion date: Aug 2023 --> Nov 2023
- Carvykti (ciltacabtagene autoleucel) / J&J
Efficacy and safety of cilta-cel in patients with progressive multiple myeloma after exposure to BCMA-targeting antibody-drug conjugate treatment (Petree Hall C) - Jul 21, 2022 - Abstract #IMW2022IMW_182;
P2
MM patients who had previous exposure to an anti-BCMA ADC therapy had favorable responses, DOR, and PFS following cilta-cel. These results may inform treatment plans, including sequencing and washout period between BCMA-targeting agents.
- || REGN5459 / Regeneron, linvoseltamab (REGN5458) / Regeneron, Sanofi
Trial completion date, Trial initiation date, Trial primary completion date: An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive A Kidney Transplant (clinicaltrials.gov) - Feb 21, 2022
P=N/A, N=12, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals
These results may inform treatment plans, including sequencing and washout period between BCMA-targeting agents. Trial completion date: Feb 2027 --> Jan 2026 | Initiation date: Mar 2022 --> Jul 2022 | Trial primary completion date: Feb 2027 --> Jan 2026
- || REGN5459 / Regeneron, Sanofi, linvoseltamab (REGN5458) / Regeneron, Sanofi
Trial completion date, Trial primary completion date: Study for Desensitization of Chronic Kidney Disease in Adult Patients in Need of a Kidney Transplant Who Are Highly Sensitized to Human Leukocyte Antigen (clinicaltrials.gov) - Feb 21, 2022
P1/2, N=60, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals
Trial completion date: Feb 2027 --> Jan 2026 | Initiation date: Mar 2022 --> Jul 2022 | Trial primary completion date: Feb 2027 --> Jan 2026 Trial completion date: Mar 2025 --> Jul 2025 | Trial primary completion date: Mar 2025 --> Jul 2025
- ||| REGN5459 / Regeneron, Sanofi
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM) (clinicaltrials.gov) - Jan 5, 2022
P1/2, N=43, Active, not recruiting, Sponsor: Regeneron Pharmaceuticals
Trial completion date: Mar 2025 --> Jul 2025 | Trial primary completion date: Mar 2025 --> Jul 2025 Recruiting --> Active, not recruiting | N=70 --> 43 | Trial completion date: Mar 2025 --> Aug 2023 | Trial primary completion date: Feb 2025 --> Aug 2023
- |||||| REGN5459 / Regeneron, linvoseltamab (REGN5458) / Regeneron, Sanofi
New trial: An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive A Kidney Transplant (clinicaltrials.gov) - Nov 2, 2021
P=N/A, N=12, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals
- |||| REGN5459 / Regeneron, Sanofi, linvoseltamab (REGN5458) / Regeneron, Sanofi
New P1/2 trial: Study for Desensitization of Chronic Kidney Disease in Adult Patients in Need of a Kidney Transplant Who Are Highly Sensitized to Human Leukocyte Antigen (clinicaltrials.gov) - Oct 24, 2021
P1/2, N=60, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals
- || REGN5459 / Regeneron, Sanofi
Trial completion date, Trial primary completion date: First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM) (clinicaltrials.gov) - Apr 22, 2021
P1/2, N=70, Recruiting, Sponsor: Regeneron Pharmaceuticals
Recruiting --> Active, not recruiting | N=70 --> 43 | Trial completion date: Mar 2025 --> Aug 2023 | Trial primary completion date: Feb 2025 --> Aug 2023 Trial completion date: Oct 2023 --> Mar 2025 | Trial primary completion date: Sep 2023 --> Feb 2025
- | REGN5459 / Regeneron, Sanofi
Enrollment open: First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM) (clinicaltrials.gov) - Oct 9, 2019
P1/2, N=56, Recruiting, Sponsor: Regeneron Pharmaceuticals
Trial completion date: Oct 2023 --> Mar 2025 | Trial primary completion date: Sep 2023 --> Feb 2025 Not yet recruiting --> Recruiting
- | REGN5459 / Regeneron, Sanofi
New P1/2 trial: First In Human (FIH) Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma (MM) (clinicaltrials.gov) - Sep 9, 2019
P1/2, N=56, Not yet recruiting, Sponsor: Regeneron Pharmaceuticals