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- || JNJ-63709178 / J&J, Genmab
P1 data, Journal: First-in-Human Study of JNJ-63709178, a CD123/CD3 Targeting Antibody, in Relapsed/Refractory Acute Myeloid Leukemia. (Pubmed Central) - Mar 16, 2023
Minimal clinical activity was observed across all cohorts. IV and SC dosing of JNJ-63709178 was associated with suboptimal drug exposure, unfavorable safety profiles, limited clinical activity, and inability to identify a recommended Phase 2 dose.
- ||||| JNJ-63709178 / J&J, Genmab
Clinical: 👉👉👉 First‐in‐Human Study of #JNJ63709178, a #CD123/#CD3 Targeting Antibody, in patients with Relapsed/Refractory Acute Myeloid Leukemia| @DrPinkalDesai @doctorpemm #leusm || https://t.co/Q8PkbE0iKr | #ImmunoOnc #bispecificAntibodies #CD123 (Twitter) - Jan 2, 2023
- ||| JNJ-63709178 / J&J, Genmab
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Aug 31, 2021
P1, N=62, Completed, Sponsor: Janssen Research & Development, LLC
IV and SC dosing of JNJ-63709178 was associated with suboptimal drug exposure, unfavorable safety profiles, limited clinical activity, and inability to identify a recommended Phase 2 dose. Recruiting --> Completed | N=120 --> 62 | Trial completion date: Oct 2022 --> Mar 2021 | Trial primary completion date: May 2022 --> Mar 2021
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Clinical: Open @LeukemiaMDA Clinical Study #2019-0911 of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Subjects with Relapsed or Refractory #AML | PI: Naveen Pemmaraju, MD, @doctorpemm of MD Anderson #Leukemia | NCT02715011 | https://t.co/x83Rlcd7OX #ClinicalTrial #leusm (Twitter) - Apr 7, 2021
P1
- | JNJ-63709178 / J&J, Genmab
Trial primary completion date: Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Dec 14, 2020
P1, N=120, Recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Completed | N=120 --> 62 | Trial completion date: Oct 2022 --> Mar 2021 | Trial primary completion date: May 2022 --> Mar 2021 Trial primary completion date: Oct 2020 --> May 2022
- | JNJ-63709178 / J&J, Genmab
Trial completion date: Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Sep 11, 2020
P1, N=120, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Oct 2020 --> May 2022 Trial completion date: Oct 2022 --> May 2022
- | JNJ-63709178 / J&J, Genmab
Trial completion date: Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Jan 3, 2020
P1, N=120, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Oct 2022 --> May 2022 Trial completion date: May 2022 --> Oct 2022
- | JNJ-63709178 / J&J, Genmab
Enrollment change, Trial completion date: Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Nov 15, 2019
P1, N=120, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: May 2022 --> Oct 2022 N=60 --> 120 | Trial completion date: Oct 2021 --> May 2022
- DARTS, Bites and ADCs for the Treatment of AML and for Conditioning for Allogeneic Stem Cell Transplantation () - Sep 26, 2019 - Abstract #SOHO2019SOHO_275;
Additional correlative studies will be presented for this and other AML bispecifics currently being tested by our and other groups in the clinic. Finally, we will present data on the use of ADCs for the treatment of AML in vitro and for conditioning for stem cell transplantation within and across MHC barriers using mouse preclinical transplant models.
- | AMV-564 / J&J, Affimed, flotetuzumab (MGD006) / Servier, MacroGenics, JNJ-63709178 / J&J, Genmab
Review, Journal: Bispecific Antibodies for the Treatment of Acute Myeloid Leukemia. (Pubmed Central) - Jun 15, 2019
Bispecific antibodies represent a promising immunotherapeutic approach for the treatment of cancer. The results of ongoing studies in AML will elucidate the potential for these agents in AML.
- | JNJ-63709178 / J&J, Genmab
Enrollment open, Trial completion date: Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Nov 20, 2018
P1, N=60, Recruiting, Sponsor: Janssen Research & Development, LLC
The results of ongoing studies in AML will elucidate the potential for these agents in AML. Trial completion date: Apr 2021 --> Aug 2021 | Suspended --> Recruiting
- | JNJ-63709178 / J&J, Genmab
Trial completion date: Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Aug 13, 2018
P1, N=60, Suspended, Sponsor: Janssen Research & Development, LLC
Trial completion date: Apr 2021 --> Aug 2021 | Suspended --> Recruiting Trial completion date: Oct 2020 --> Apr 2021
- || JNJ-63709178 / J&J, Genmab
Trial primary completion date: Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Nov 21, 2017
P1, N=60, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial completion date: Oct 2020 --> Apr 2021 Trial primary completion date: Nov 2017 --> Oct 2020
- ||| JNJ-63709178 / J&J, Genmab
Enrollment open: Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Apr 7, 2017
P1, N=60, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Nov 2017 --> Oct 2020 Suspended --> Recruiting
- | JNJ-63709178 / J&J, Genmab
Trial suspension: Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Sep 16, 2016
P1, N=60, Suspended, Sponsor: Janssen Research & Development, LLC
Suspended --> Recruiting Recruiting --> Suspended
- | JNJ-63709178 / J&J, Genmab
Phase classification: Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Aug 25, 2016
P1, N=60, Recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Suspended Phase classification: P2 --> P1
- | JNJ-63709178 / J&J, Genmab
Phase classification: Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Aug 4, 2016
P2, N=60, Recruiting, Sponsor: Janssen Research & Development, LLC
Phase classification: P2 --> P1 Phase classification: P1 --> P2
- ||| JNJ-63709178 / J&J, Genmab
Enrollment open: Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Jun 9, 2016
P1, N=60, Recruiting, Sponsor: Janssen Research & Development, LLC
Phase classification: P1 --> P2 Not yet recruiting --> Recruiting
- ||| JNJ-63709178 / J&J, Genmab
New P1 trial: Dose Escalation Study of JNJ-63709178, a Humanized CD123 x CD3 DuoBody in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov) - Mar 22, 2016
P1, N=60, Not yet recruiting, Sponsor: Janssen Research & Development, LLC