 |
Diseases |  |
Trials |
|
Trials |  |
News |  |
| 12» |
- ||| lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
Trial completion, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy: A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - Feb 28, 2024
P1/2, N=105, Completed, Sponsor: I-Mab Biopharma Co. Ltd.
Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Dec 2023 | Trial primary completion date: Dec 2024 --> Dec 2023
- ||| Venclexta (venetoclax) / Roche, AbbVie
Phase classification, Trial termination, Adverse events, Combination therapy: Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome (clinicaltrials.gov) - Feb 25, 2024
P1, N=40, Terminated, Sponsor: AbbVie
Active, not recruiting --> Completed | Trial completion date: Dec 2024 --> Dec 2023 | Trial primary completion date: Dec 2024 --> Dec 2023 Phase classification: P1b --> P1 | Completed --> Terminated; Strategic considerations
- || lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy: A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - Feb 15, 2024
P1/2, N=105, Active, not recruiting, Sponsor: I-Mab Biopharma Co. Ltd.
Phase classification: P1b --> P1 | Completed --> Terminated; Strategic considerations Trial completion date: Feb 2024 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Dec 2024
- || lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
Trial completion date, Trial primary completion date, Combination therapy, Monotherapy: A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - Sep 13, 2023
P1/2, N=105, Active, not recruiting, Sponsor: I-Mab Biopharma Co. Ltd.
Trial completion date: Feb 2024 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Dec 2024 Trial completion date: Aug 2023 --> Feb 2024 | Trial primary completion date: Apr 2023 --> Oct 2023
- ||| lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
Trial completion, Trial completion date, Trial primary completion date, Metastases: KEYNOTE-A21: Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma (clinicaltrials.gov) - Aug 30, 2023
P1, N=98, Completed, Sponsor: AbbVie
Trial completion date: Aug 2023 --> Feb 2024 | Trial primary completion date: Apr 2023 --> Oct 2023 Active, not recruiting --> Completed | Trial completion date: Sep 2023 --> Jan 2023 | Trial primary completion date: Sep 2023 --> Jan 2023
- || Venclexta (venetoclax) / Roche, AbbVie
Trial completion, Enrollment change, Adverse events, Combination therapy: Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome (clinicaltrials.gov) - May 25, 2023
P1b, N=40, Completed, Sponsor: AbbVie
Active, not recruiting --> Completed | Trial completion date: Sep 2023 --> Jan 2023 | Trial primary completion date: Sep 2023 --> Jan 2023 Active, not recruiting --> Completed | N=80 --> 40
- || lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
Enrollment closed, Combination therapy, Monotherapy: A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - Apr 25, 2023
P1/2, N=105, Active, not recruiting, Sponsor: I-Mab Biopharma Co. Ltd.
Active, not recruiting --> Completed | N=80 --> 40 Recruiting --> Active, not recruiting
- |||||| lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
Enrollment open, Combination therapy, Monotherapy: A Phase 3 Clinical Study to Evaluate Lemzoparlimab for Injection in Combination With Azacitidine (AZA) Versus AZA Monotherapy in Treatment-na (clinicaltrials.gov) - Apr 10, 2023
P3, N=552, Recruiting, Sponsor: I-Mab Biopharma Co. Ltd.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | Loqtorzi (toripalimab-tpzi) / Shanghai Junshi Biosci, Coherus Biosci, lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Combination therapy, Metastases: A Study of Single Drug TJ011133 and Toripalimab Combine Treatment for Advanced Solid Tumor (clinicaltrials.gov) - Feb 10, 2023
P1/2, N=7, Terminated, Sponsor: I-Mab Biopharma Co. Ltd.
Not yet recruiting --> Recruiting N=96 --> 7 | Trial completion date: Sep 2025 --> Feb 2023 | Recruiting --> Terminated | Trial primary completion date: Dec 2023 --> Feb 2023; Company Development strategy adjustment
- |||||||||| lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
New P3 trial, Combination therapy, Monotherapy: A Phase 3 Clinical Study to Evaluate Lemzoparlimab for Injection in Combination With Azacitidine (AZA) Versus AZA Monotherapy in Treatment-na (clinicaltrials.gov) - Feb 1, 2023
P3, N=552, Not yet recruiting, Sponsor: I-Mab Biopharma Co. Ltd.
- Darzalex (daratumumab) / J&J, felzartamab (MOR202) / HIBio, lemzoparlimab (ABBV-IMAB-TJC4) / AbbVie
Exploration of the Therapeutic Effects of CD47 and CD38 Antibody Combination in Relapsed or Refractory Multiple Myeloma (rrMM) and the Correlation with CD47 and CD38 Expression (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_6287;
Combination of lemzoparlimab and felzartamab showed enhanced in vitro ADCP and in vivo anti-tumor efficacy in these CD47 high and CD38 low high-risk MM cells which were resistant to felzartamab or daratumumab mono-treatment. Our study provides preclinical evidence to explore the combination of lemzoparlimab and felzartamab in the treatment of high-risk MM patients.
- lemzoparlimab (ABBV-IMAB-TJC4) / AbbVie
Molecular Biomarker Analyses for Exploring the Therapeutic Mechanism of Lemzoparlimab and Azacitidine (AZA) in Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_5778;
P1/2
In addition, TP53 mutant patients with a higher increase in CALR expression and immune infiltrates in bone marrow showed a better clinical response than those with WT TP53. Our results pinpoint the potential mechanism of clinical benefits observed with lemzoparlimab and AZA treatment in HR-MDS and provide insight into future combination strategies.
- || Venclexta (venetoclax) / Roche, AbbVie
Enrollment change, Trial completion date, Trial primary completion date, Adverse events, Combination therapy: Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome (clinicaltrials.gov) - Oct 21, 2022
P1b, N=80, Active, not recruiting, Sponsor: AbbVie
Our results pinpoint the potential mechanism of clinical benefits observed with lemzoparlimab and AZA treatment in HR-MDS and provide insight into future combination strategies. N=38 --> 80 | Trial completion date: Mar 2024 --> Jul 2023 | Trial primary completion date: Mar 2024 --> Jul 2023
- | Venclexta (venetoclax) / Roche, AbbVie, lemzoparlimab (ABBV-IMAB-TJC4) / AbbVie
Journal, Combination therapy: Anti-CD47 immunotherapy in combination with BCL-2 inhibitor to enhance anti-tumor activity in B-cell lymphoma. (Pubmed Central) - Oct 12, 2022
In vitro and in vivo, the TJC4-Venetoclax combination increased phagocytosis significantly compared with either agent alone, showing synergistic phagocytosis, and displayed synergistic anti-cancer properties in B-cell lymphoma. Our results support the TJC4-Venetoclax combination as a promising therapy, and suppressing BCL-2 and CD47 simultaneously could represent a novel therapeutic paradigm for B-cell lymphoma.
- lemzoparlimab (ABBV-IMAB-TJC4) / AbbVie
Combination of HER2 ADC and lemzoparlimab elicits enhanced efficacy in both HER2 high-and low-expressing breast and gastric cancers (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_1171;
In vivo activity of RC48 or in-house produced DS8201 analogue in combination with lemzoparlimab were investigated in CDX (HER2 0/1+/3+ by IHC) and PDX (HER2 2+ by IHC) models...Lemzoparlimab potentiated HER2 ADC mediated tumor killing by modulating NK cells and macrophage activity to increase cytotoxicity and phagocytosis. These data support future clinical investigation of lemzoparlimab and HER2 ADC combination in HER2 positive patients, especially those with HER2-low expressing tumors.
- HCB101: A safe and effective ligand trap therapeutic targeting the CD47-SIRPa signaling pathway for cancer treatment (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_831;
Moreover, it exhibits outstanding protein stability and manufactural characteristics for large-scale production. Clinical development of HCB101 is currently underway both as monotherapy and in combination.
- lemzoparlimab (ABBV-IMAB-TJC4) / AbbVie
Experience with TJ011133 Anti-CD47 and Pretransfusion Testing (Orange County Convention Center - Hall E) - Sep 26, 2022 - Abstract #AABB2022AABB_145;
Unlike another IgG4 drug therapy, Hu5F9-G4 anti-CD47 (Magrolimab) previously described (Velliquette et al. Transfusion.
- || Venclexta (venetoclax) / Roche, AbbVie
Enrollment closed, Enrollment change, Adverse events, Combination therapy: Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome (clinicaltrials.gov) - Aug 29, 2022
P1b, N=38, Active, not recruiting, Sponsor: AbbVie
Transfusion. Recruiting --> Active, not recruiting | N=80 --> 38
- || lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
Enrollment closed, Metastases: KEYNOTE-A21: Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma (clinicaltrials.gov) - Aug 24, 2022
P1, N=98, Active, not recruiting, Sponsor: AbbVie
Recruiting --> Active, not recruiting | N=80 --> 38 Recruiting --> Active, not recruiting
- ||| lemzoparlimab (ABBV-IMAB-TJC4) / AbbVie
$ABBV says bye bye to lemzoparlimab trials, adding to list of CD47 disappointments. Via @evaluatevantage https://t.co/8k4F2i6KoC $IMAB $SURF $GILD $ALXO $ZLAB (Twitter) - Aug 17, 2022
- lemzoparlimab (ABBV-IMAB-TJC4) / AbbVie
Lemzoparlimab, a differentiated anti-CD47 monoclonal antibody, in combination with azacitidine (AZA) in patients with newly diagnosed higher risk myelodysplastic syndrome (HR-MDS): Initial clinical results (7.3.Q - Quimper Auditorium) - Jul 25, 2022 - Abstract #ESMO2022ESMO_1528;
P1/2
Conclusions Without a priming dose of lemzoparlimab, combination treatment with AZA is well tolerated and showed clinically meaningful efficacy results in newly diagnosed HR-MDS. A randomized phase 3 MDS trial is planned.
- lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Adverse events, Combination therapy: Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Lemzoparlimab With or Without Oral/IV Dexamethasone and in Combination With Oral/IV/Subcutaneous Anti-Myeloma Regimens in Adult Participants With Multiple Myeloma (clinicaltrials.gov) - Jul 8, 2022
P1b, N=8, Terminated, Sponsor: AbbVie
A randomized phase 3 MDS trial is planned. N=163 --> 8 | Trial completion date: Aug 2025 --> Jun 2022 | Recruiting --> Terminated | Trial primary completion date: Aug 2025 --> Jun 2022; Strategic considerations
- Venclexta (venetoclax) / Roche, AbbVie, lemzoparlimab (ABBV-IMAB-TJC4) / AbbVie
LEMZOPARLIMAB (LEMZO) WITH VENETOCLAX (VEN) AND/OR AZACITIDINE (AZA) IN PATIENTS (PTS) WITH ACUTE MYELOID LEUKEMIA (AML) OR MYELODYSPLASTIC SYNDROMES (MDS): A PHASE 1B DOSE ESCALATION STUDY () - May 13, 2022 - Abstract #EHA2022EHA_924;
P1b
Time-to-event endpoints will be analyzed using Kaplan–Meier methodology. Results N/A Conclusion N/A
- Venclexta (venetoclax) / Roche, AbbVie, lemzoparlimab (ABBV-IMAB-TJC4) / AbbVie
Lemzoparlimab (lemzo) with venetoclax (ven) and/or azacitidine (aza) in patients (pts) with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS): A phase 1b dose escalation study. (Available On Demand; 296a) - Apr 28, 2022 - Abstract #ASCO2022ASCO_4304;
P1b
Response rates will be analyzed with estimates and 95% confidence intervals based on exact binomial distribution. Time-to-event endpoints will be analyzed using Kaplan–Meier methodology.
- || lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
Trial initiation date, Adverse events, Combination therapy: Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Lemzoparlimab With or Without Oral/IV Dexamethasone and in Combination With Oral/IV/Subcutaneous Anti-Myeloma Regimens in Adult Participants With Multiple Myeloma (clinicaltrials.gov) - Apr 8, 2022
P1b, N=163, Recruiting, Sponsor: AbbVie
Time-to-event endpoints will be analyzed using Kaplan–Meier methodology. Initiation date: Sep 2021 --> Jan 2022
- || lemzoparlimab (ABBV-IMAB-TJC4) / AbbVie
Hi Jam - maybe try Reuben @KCH he had a couple of bispecific trials opening soon although not sure if BCMA naive needed. I have Lemzoparlimab combination trial opening in a few months but prob not soon enough (Twitter) - Feb 16, 2022
- |||||| Venclexta (venetoclax) / Roche, AbbVie, azacitidine / Generic mfg., lemzoparlimab (ABBV-IMAB-TJC4) / AbbVie
Clinical, Combination therapy: Open @MDAndersonNews #ClinicalTrial #2021-0503 A Phase 1b Dose Escalation Study of Lemzoparlimab in Combination with Venetoclax and/or Azacitidine in Subjects with #AML or #MDS | PI: Naval Daver @Daver_Leukemia | NCT04912063 https://t.co/WeBNJ2SFBb #leusm (Twitter) - Jan 21, 2022
P1b
- ||| Loqtorzi (toripalimab-tpzi) / Shanghai Junshi Biosci, Coherus Biosci, lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
Enrollment open, Trial primary completion date, Combination therapy, Metastases: A Study of Single Drug TJ011133 and Toripalimab Combine Treatment for Advanced Solid Tumor (clinicaltrials.gov) - Jan 20, 2022
P1/2, N=96, Recruiting, Sponsor: I-Mab Biopharma Co. Ltd.
Initiation date: Sep 2021 --> Jan 2022 Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2021 --> Dec 2023
- || lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
Trial primary completion date, Metastases: KEYNOTE-A21: Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma (clinicaltrials.gov) - Dec 23, 2021
P1, N=116, Recruiting, Sponsor: AbbVie
Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2021 --> Dec 2023 Trial primary completion date: Feb 2022 --> Sep 2023
- |||| Loqtorzi (toripalimab-tpzi) / Shanghai Junshi Biosci, Coherus Biosci, lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
New P1/2 trial, Combination therapy, Metastases: A Study of Single Drug TJ011133 and Toripalimab Combine Treatment for Advanced Solid Tumor (clinicaltrials.gov) - Dec 7, 2021
P1/2, N=96, Not yet recruiting, Sponsor: I-Mab Biopharma Co. Ltd.
- Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche, lemzoparlimab (TJC4) / AbbVie
Lemzoparlimab, a Differentiated Anti-CD47 Antibody in Combination with Rituximab in Relapsed and Refractory Non-Hodgkin’s Lymphoma: Initial Clinical Results (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_5229;
P1
The combination therapy exhibited evidence of clinical activity in heavily pre-treated R/R NHL patients who had progressed on prior CD20 targeted therapies. The results provide the basis for RP2D and impetus for accelerated clinical development for NHL.
- ||| Venclexta (venetoclax) / Roche, AbbVie
Enrollment open, Adverse events, Combination therapy: Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome (clinicaltrials.gov) - Oct 31, 2021
P1b, N=80, Recruiting, Sponsor: AbbVie
The results provide the basis for RP2D and impetus for accelerated clinical development for NHL. Suspended --> Recruiting
- || lemzoparlimab (TJC4) / AbbVie
Clinical: #IMab Reports Multiple Positive Clinical Updates of Differentiated #CD47Antibody #Lemzoparlimab $IMAB https://t.co/CsFb2BiDC4 (Twitter) - Oct 4, 2021
- Darzalex IV (daratumumab) / J&J, lemzoparlimab (TJC4) / AbbVie
Lemzoparlimab (TJ011133), an anti-CD47 antibody, with/without dexamethasone plus anti-myeloma regimens for relapsed/refractory multiple myeloma: a phase 1b dose escalation and expansion study (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_968;
P1b
Time-to-event endpoints will be analyzed using the Kaplan–Meier method. Trial Registration ClinicalTrials.gov: NCT04895410
- ||| lemzoparlimab (TJC4) / AbbVie
Clinical: $IMAB I-Mab Reports Multiple Positive Clinical Updates of Differentiated CD47 Antibody Lemzoparlimab https://t.co/TjuMt0A4I8 (Twitter) - Sep 30, 2021
- ||| lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
Enrollment open, Adverse events, Combination therapy: Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Lemzoparlimab With or Without Oral/IV Dexamethasone and in Combination With Oral/IV/Subcutaneous Anti-Myeloma Regimens in Adult Participants With Multiple Myeloma (clinicaltrials.gov) - Sep 20, 2021
P1b, N=170, Recruiting, Sponsor: AbbVie
Trial Registration ClinicalTrials.gov: NCT04895410 Not yet recruiting --> Recruiting
- | Venclexta (venetoclax) / Roche, AbbVie
Enrollment change, Trial suspension, Adverse events, Combination therapy: Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome (clinicaltrials.gov) - Sep 2, 2021
P1b, N=80, Suspended, Sponsor: AbbVie
Not yet recruiting --> Recruiting N=120 --> 80 | Recruiting --> Suspended
- ||| Venclexta (venetoclax) / Roche, AbbVie
Enrollment open, Enrollment change, Adverse events, Combination therapy: Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome (clinicaltrials.gov) - Jun 18, 2021
P1b, N=120, Recruiting, Sponsor: AbbVie
N=120 --> 80 | Recruiting --> Suspended Not yet recruiting --> Recruiting | N=80 --> 120
- ||| Venclexta (venetoclax) / Roche, AbbVie
New P1 trial, Adverse events, Combination therapy: Study to Evaluate Adverse Events and Movement of Lemzoparlimab in Body When Used Intravenously (IV) With Azacitidine Subcutaneously or IV and Venetoclax Orally in Participants With Acute Myeloid Leukemia and With Azacitidine With or Without Venetoclax in Participants With Myelodysplastic Syndrome (clinicaltrials.gov) - Jun 3, 2021
P1b, N=80, Not yet recruiting, Sponsor: AbbVie
- || lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
Enrollment change, Metastases: KEYNOTE-A21: Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma (clinicaltrials.gov) - May 24, 2021
P1, N=116, Recruiting, Sponsor: I-Mab Biopharma Co. Ltd.
Not yet recruiting --> Recruiting | N=80 --> 120 N=88 --> 116
- ||| lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
New P1 trial, Adverse events, Combination therapy: Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Lemzoparlimab With or Without Oral/IV Dexamethasone and in Combination With Oral/IV/Subcutaneous Anti-Myeloma Regimens in Adult Participants With Multiple Myeloma (clinicaltrials.gov) - May 19, 2021
P1b, N=163, Not yet recruiting, Sponsor: AbbVie
- ||| lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
Enrollment change, Trial completion date, Trial primary completion date, Combination therapy, Monotherapy: A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - Apr 22, 2021
P1/2, N=80, Recruiting, Sponsor: I-Mab Biopharma Co. Ltd.
N=88 --> 116 N=42 --> 80 | Trial completion date: Dec 2021 --> Aug 2023 | Trial primary completion date: Dec 2021 --> Apr 2023
- lemzoparlimab (TJC4) / AbbVie
[VIRTUAL] A Phase I/IIa Study of Lemzoparlimab, a Monoclonal Antibody Targeting CD47, in Patients with Relapsed and/or Refractory Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS): Initial Phase I Results () - Nov 5, 2020 - Abstract #ASH2020ASH_4982;
P1/2
The preliminary efficacy observed was encouraging. Dose escalation will continue until MTD or RP2D is reached.
- Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche, lemzoparlimab (TJC4) / AbbVie
[VIRTUAL] A first-in-human study of lemzoparlimab, a differentiated anti-CD47 antibody, in subjects with relapsed/refractory malignancy: initial monotherapy results () - Oct 14, 2020 - Abstract #SITC2020SITC_1416;
P1
No TRAEs greater than Grade 2 have been observed. Results will be updated at presentation including available tumor response data.
- Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche, lemzoparlimab (TJC4) / AbbVie
[VIRTUAL] A first-in-human study of lemzoparlimab, a differentiated anti-CD47 antibody, in subjects with relapsed/refractory malignancy: initial monotherapy results () - Oct 14, 2020 - Abstract #SITC2020SITC_681;
P1
No TRAEs greater than Grade 2 have been observed. Results will be updated at presentation including available tumor response data.
- || lemzoparlimab (TJC4) - I / Mab
$IMAB lemzoparlimab ph1 data at #SITC20. They completed US ph1 dose escalation really quickly. (Twitter) - Sep 4, 2020
- | lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
Enrollment status, Combination therapy, Monotherapy: A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - Jun 11, 2020
P1/2, N=42, Recruiting, Sponsor: I-Mab Biopharma HongKong Limited
Results will be updated at presentation including available tumor response data. Enrolling by invitation --> Recruiting
- || lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
Enrollment open, Combination therapy, Monotherapy: A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - Mar 30, 2020
P1/2, N=42, Enrolling by invitation, Sponsor: I-Mab Biopharma HongKong Limited
Enrolling by invitation --> Recruiting Not yet recruiting --> Enrolling by invitation
- | lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
Trial initiation date, Combination therapy, Monotherapy: A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - Mar 27, 2020
P1/2, N=42, Not yet recruiting, Sponsor: I-Mab Biopharma HongKong Limited
Not yet recruiting --> Enrolling by invitation Initiation date: Dec 2019 --> Apr 2020
- || lemzoparlimab (ABBV-IMAB-TJC4) - I / Mab
New P1/2 trial, Combination therapy, Monotherapy: A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 as Monotherapy and in Combination With Azacitidine (AZA) in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - Dec 17, 2019
P1/2, N=42, Not yet recruiting, Sponsor: I-Mab Biopharma HongKong Limited