Tafasitamab for Thrombocytopenic Purpura

Recruiting at 38 trial locations

Overseen By Incyte Corporation Call Center (ex-US)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Incyte Corporation

Must not be taking: Anti-CD19 therapy, Anticoagulants

Disqualifiers: Cold agglutinin disease, Severe infections, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of tafasitamab, a monoclonal antibody, for individuals with certain autoimmune blood disorders. It specifically targets those with primary immune thrombocytopenia (ITP), which causes low platelet counts and easy bruising, and primary warm autoimmune hemolytic anemia (wAIHA), which can lead to fatigue and shortness of breath due to red blood cell destruction. Participants should have one of these conditions, have previously tried treatments like corticosteroids or rituximab, and still require further treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that tafasitamab is likely to be safe for humans?

Research has shown that tafasitamab is generally well-tolerated by patients. Some individuals might experience allergic reactions, a common occurrence with many medicines targeting specific cells. However, aside from these expected reactions, patients have accepted the treatment well.

When used to treat conditions like diffuse large B-cell lymphoma (a type of cancer), tafasitamab has demonstrated a good safety profile, meaning most people can take it without major issues. As this trial is in the middle stages, some evidence already suggests the treatment is safe for humans, though further research is needed to confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Tafasitamab is unique because it offers a new approach for treating conditions like primary immune thrombocytopenia (ITP) and primary warm autoimmune hemolytic anemia (wAIHA), which are often managed with corticosteroids, immunoglobulins, or splenectomy. Most treatments for these conditions work by broadly suppressing the immune system. But Tafasitamab works differently, targeting and modifying B-cells, which are key players in the body’s immune response. This targeted action could potentially offer more effective and precise treatment with fewer side effects. Researchers are excited about Tafasitamab's potential to provide a more focused therapy, improving patient outcomes and quality of life.

What evidence suggests that tafasitamab might be an effective treatment for thrombocytopenic purpura?

Research has shown that tafasitamab might help treat autoimmune blood cell disorders. In this trial, participants with primary immune thrombocytopenia (ITP) will receive tafasitamab. Studies found that when combined with lenalidomide, tafasitamab helped over 74% of patients prevent their condition from worsening for more than two years, suggesting potential benefits for people with ITP. Participants with warm autoimmune hemolytic anemia (wAIHA) will also receive tafasitamab. Although specific evidence for tafasitamab in wAIHA is limited, it targets autoimmune disorders by preventing the immune system from attacking healthy cells. Early results suggest it could be a promising treatment for these conditions. ^{1 6 7 8 9}

Who Is on the Research Team?

Incyte Medical Monitor

Principal Investigator

Incyte Corporation

Are You a Good Fit for This Trial?

Adults with primary autoimmune blood cell disorders like ITP or wAIHA, who've had at least one standard rituximab treatment but still need help. They should have seen some improvement after treatment but then got worse, or didn't respond well enough. People can't join if they've had their spleen removed or haven't understood and agreed to the study's consent form.

Inclusion Criteria

I can understand and am willing to sign the consent form for the study.

My platelet count has doubled and is now above 30.

My hemoglobin increased to at least 10 g/dL and by 2 g/dL from the start.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tafasitamab intravenously for primary autoimmune blood cell disorders

48 weeks

Regular visits for intravenous administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tafasitamab

Trial Overview The trial is testing Tafasitamab (INCA000585), a medication aimed at improving conditions such as Thrombocytopenic Purpura by increasing platelet counts and hemoglobin levels in adults with certain autoimmune blood disorders.

How Is the Trial Designed?

Group I: Cohort 2 - primary warm autoimmune hemolytic anemia (wAIHA) Experimental Treatment 1 Intervention

INCA000585 will be administered intravenously.

Group II: Cohort 1 - primary immune thrombocytopenia (ITP) Experimental Treatment 1 Intervention

INCA000585 will be administered intravenously.

Who Is Running the Clinical Trial?

Incyte Corporation

Lead Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07104565

NCT07104565 | Study to Assess the Safety and Tolerability ... This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders. ... Cohort 1 - primary immune ...

2. theglobeandmail.com theglobeandmail.com/investing/markets/markets-news/Tipranks/35739136/incytes-new-study-on-tafasitamab-a-potential-game-changer-for-autoimmune-disorders/

Incyte's New Study on Tafasitamab: A Potential Game- ... This drug is designed to target specific autoimmune blood cell disorders, potentially improving patient outcomes. The study design is ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10651865/

Safety and efficacy of tafasitamab with or without lenalidomide ... The authors' data from 66 patients suggest acceptable safety and encouraging efficacy with 2-year progression-free survival exceeding 74%, thereby forming the ...

4. ashpublications.org ashpublications.org/blood/article/146/Supplement%201/1819/549921/Phase-3-study-inMIND-of-tafasitamab-plus

Phase 3 study (inMIND) of tafasitamab plus lenalidomide and ... The primary analysis from the inMIND (NCT04680052) study demonstrated significant improvement in investigator-assessed PFS in pts with R/R FL ...

5. library.ehaweb.org library.ehaweb.org/eha/2020/eha25th/293691/gilles.salles.long-term.outcomes.from.the.phase.ii.l-mind.study.of.tafasitamab.html

LONG-TERM OUTCOMES FROM THE PHASE II L-MIND ... In this long-term analysis of the L-MIND data, of 81 enrolled patients, 80 received tafasitamab + LEN and were included in the full analysis set for efficacy.

6. ema.europa.eu ema.europa.eu/en/documents/rmp/minjuvi-epar-risk-management-plan_en.pdf

Risk Management Plan for MINJUVI (tafasitamab) The primary safety database for this RMP comprises analysis of the clinical safety data from the. MOR208C203 (L-MIND) study, employing the ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2020/761163Orig1s000MultidisciplineR.pdf

761163Orig1s000 - accessdata.fda.gov The evaluation of safety is based on the primary safety analysis comprising data from the. 81 patients in the pivotal MOR208C203 study, and ...

8. onclive.com onclive.com/view/dr-abdulhaq-on-the-safety-profile-of-tafasitamab-in-dlbcl

Dr. Abdulhaq on the Safety Profile of Tafasitamab in DLBCL Adverse events are expected with a monoclonal antibody, such as allergic reactions, but otherwise, it was well tolerated, and those events ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38843478/

Fostamatinib effectiveness and safety for immune ... Fostamatinib was shown to be effective with good safety profile in patients with primary and secondary ITP across a wide age spectrum in this real-world study.