JSP191 for Myelodysplastic Syndrome

No longer recruiting at 1 trial location

Overseen By Harold Pestana

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jasper Therapeutics, Inc.

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 32 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called JSP191 for individuals with myelodysplastic syndrome (MDS), specifically those with low-risk types experiencing symptoms such as frequent low blood cell counts. The main goal is to determine if JSP191 is safe and well-tolerated as a second-line therapy, used after other treatments have failed. Participants will receive varying doses of JSP191 to identify the optimal amount. Suitable candidates have MDS and symptoms like low blood counts. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the JSP191 trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

Is there any evidence suggesting that JSP191 is likely to be safe for humans?

Research shows that JSP191 is generally safe for people. In earlier studies, 24 patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) received JSP191 without experiencing serious side effects, suggesting it is well tolerated.

In another study, 17 patients with MDS or AML also took JSP191 and reported no severe side effects. These findings support the idea that JSP191 does not cause serious harm.

While these results are encouraging, it's important to remember that JSP191 remains in the early stages of testing. Although safety information is limited, current evidence suggests it is safe for people to use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for Myelodysplastic Syndrome (MDS) involve chemotherapy or hypomethylating agents, which aim to control the disease and manage symptoms. However, JSP191 is unique because it targets CD117, a receptor on certain blood-forming stem cells, potentially clearing out abnormal cells more effectively. This novel mechanism could offer a more targeted approach compared to traditional therapies. Researchers are excited about JSP191 as it might provide a new avenue for treatment, especially for patients who don't respond well to existing options.

What evidence suggests that JSP191 might be an effective treatment for Myelodysplastic Syndrome?

Research has shown that JSP191, the investigational treatment in this trial, offers promising results for treating myelodysplastic syndrome (MDS). In a previous study, JSP191 helped all 17 participants produce healthy blood cells, indicating recovery. The treatment also reduced leftover cancer cells in 12 out of 15 participants. Additionally, JSP191 was well-tolerated, with no severe side effects reported. These early findings suggest that JSP191 could serve as an effective backup treatment for MDS. ^{1 2 3 5 6}

Who Is on the Research Team?

Medical Director

Principal Investigator

Jasper Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults over 18 with low to intermediate-risk Myelodysplastic Syndrome (MDS) who have symptoms like anemia or bleeding. Women able to have children must use effective birth control, and men too, during the study and for 3 months after. Participants need to understand and agree to the study's requirements.

Inclusion Criteria

I am a man who is either surgically sterile or willing to use contraception.

Women of childbearing potential (WOCBP) must agree to use a specified form of contraception

I have low blood counts causing symptoms.

Exclusion Criteria

I am pregnant or nursing and do not want to stop breastfeeding.

I have had a stem cell transplant before.

I have a history of HIV or active hepatitis B or C.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JSP191 on Day 1 of each 8-week cycle for 4 consecutive cycles

32 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JSP191

Trial Overview

The trial is testing JSP191 (Briquilimab) as a second-line treatment for MDS. It's in Phase 1, which means it's early in testing and focuses on how safe it is and what doses are tolerable when given to people.

How Is the Trial Designed?

Group I: JSP191 Experimental Treatment 1 Intervention

This study will explore up to 5 ascending dose levels (Cohorts 1, 2, 3, 4, and 5) and subjects will receive JSP191 on Day 1 on each 8-week cycle for 4 consecutive cycles.

Who Is Running the Clinical Trial?

Jasper Therapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

310+

Published Research Related to This Trial

Recent advancements in high-throughput genomic analysis have led to the identification of novel gene targets associated with myelodysplastic syndromes (MDS), enhancing our understanding of their pathogenesis.

Understanding these genetic alterations is crucial as they can inform clinical relevance and potential therapeutic strategies for MDS, which is characterized by ineffective blood cell production and a risk of progressing to acute myeloid leukemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genome-wide analysis of myelodysplastic syndromes. Sanada, M., Ogawa, S.[2019]

Myelodysplastic syndromes (MDS) are linked to a variety of genetic mutations that affect blood cell production and can lead to acute myeloid leukemia, with most patients having 2-4 driver mutations at diagnosis.

Specific mutations, like SF3B1, are associated with better outcomes, while others, such as TP53 and RUNX1, indicate poorer survival and higher disease progression risk, highlighting the importance of genetic profiling in MDS for prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Genetics of Myelodysplastic Syndromes: Clinical Relevance. Chiereghin, C., Travaglino, E., Zampini, M., et al.[2022]

In a study of 90 MDS patients and 143 healthy volunteers, specific genetic variants (TET2rs2454206 G/A, TET2rs12498609 G/C, and ASXL1rs3746609 A/G) were found to be associated with a lower prevalence of Myelodysplastic Syndromes (MDS) among individuals, suggesting a potential protective effect.

The TET2rs2454206 G/A genotype was linked to higher serum LDH levels, while the TET2rs12498609 G/C genotype was associated with a higher frequency of mutated SRSF2 and lower rates of anemia, indicating that these genetic markers may influence certain laboratory features in MDS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TET2 rs2454206, TET2 rs12498609 and ASXL1 rs3746609 single nucleotide polymorphisms in patients with myelodysplastic syndromes. Hu, J., Xu, J., Tian, T., et al.[2021]

In a study of 123 patients with myelodysplastic syndrome characterized by the deletion of the long arm of chromosome 5, the mutation pattern revealed that TP53 mutations were significantly more common in this group compared to other myelodysplastic syndrome subtypes, indicating a unique genetic profile.

SF3B1 mutations, while frequent and associated with worse prognosis in this specific cohort, showed similar outcomes to other myelodysplastic syndrome subtypes, suggesting that genetic factors may influence disease progression differently in patients with isolated chromosome 5 deletions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular analysis of myelodysplastic syndrome with isolated deletion of the long arm of chromosome 5 reveals a specific spectrum of molecular mutations with prognostic impact: a study on 123 patients and 27 genes. Meggendorfer, M., Haferlach, C., Kern, W., et al.[2018]

Myelodysplastic syndromes (MDS) in children are rare and can be linked to inherited bone marrow failure syndromes, complicating diagnosis and treatment; recent genetic mutations associated with MDS have been identified, including GATA2 and ETV6.

Allogeneic hematopoietic stem cell transplantation (HSCT) is the preferred treatment for most childhood MDS cases, especially for those with excess blasts or therapy-related MDS, with new methods improving safety by using HLA-haploidentical donors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Myelodysplastic syndromes in children. Galaverna, F., Ruggeri, A., Locatelli, F.[2019]

There have been no new drug approvals for myelodysplastic syndromes (MDS) in 13 years, highlighting a significant gap in treatment advancements since decitabine was approved in 2006.

Emerging therapies like luspatercept and imetelstat show promise for treating symptomatic anemia in lower-risk MDS patients, and future treatments are expected to be more personalized based on genetic and biomarker analyses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving therapies for lower-risk myelodysplastic syndromes. Bewersdorf, JP., Zeidan, AM.[2020]

Myelodysplastic syndromes (MDS) present significant clinical challenges due to their complex molecular landscape, which complicates the development of effective therapies and patient recruitment for clinical trials.

Recent research highlights potential therapeutic advances targeting pathways such as TGF-β, STAT3, and Hedgehog signaling, which may lead to improved patient outcomes in survival and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging Therapies for the Myelodysplastic Syndromes. Canaani, J.[2023]

Immunosuppressive therapy (IST) using antithymocyte globulin (ATG) and cyclosporine A (CSA) showed a 42% overall hematologic improvement in 66 low-risk myelodysplastic syndrome (MDS) patients, with better responses observed when treatment was initiated within 2 years of diagnosis.

Combining CSA with ATG resulted in a higher response rate (51%) compared to ATG alone (27%), and factors such as karyotype quality and timing of treatment significantly influenced patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunosuppressive Therapy: Exploring an Underutilized Treatment Option for Myelodysplastic Syndrome. Haider, M., Al Ali, N., Padron, E., et al.[2021]

In a phase II study involving 18 patients with higher-risk myelodysplastic syndrome and related conditions, dasatinib (100 mg/day) showed limited efficacy, with only 3 patients responding positively and 10 experiencing disease progression.

The treatment was found to be safe, with toxicities consistent with previous reports, indicating that while dasatinib may not be highly effective for this patient group, it does not pose significant safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II pilot study of oral dasatinib in patients with higher-risk myelodysplastic syndrome (MDS) who failed conventional therapy. Duong, VH., Jaglal, MV., Zhang, L., et al.[2015]

Recent advancements in identifying over 25 recurrent mutations in myelodysplastic syndromes (MDS) through massively parallel sequencing can enhance patient care by informing diagnosis and treatment decisions.

Some of these mutations provide prognostic information that is independent of traditional clinical risk factors, suggesting that incorporating genetic testing could lead to better risk stratification and improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New strategies in myelodysplastic syndromes: application of molecular diagnostics to clinical practice. Tothova, Z., Steensma, DP., Ebert, BL.[2021]

In a study of 28 children with myelodysplastic syndrome (MDS), common symptoms included anemia (96%), bleeding (68%), and fever (68%), with a notable 11% of cases progressing to acute leukemia within one to two months.

Multi-drug combination chemotherapy was effective in achieving partial or complete remission in 4 out of 8 cases, suggesting it may help slow disease progression in pediatric MDS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical analysis of 28 cases of pediatric myelodysplastic syndrome]. Xi, WB., Wang, D., Liu, YF.[2013]

Luspatercept-aamt, approved by the FDA in April 2020, effectively promotes erythroid maturation and demonstrated significant efficacy in the MEDALIST trial, achieving transfusion independence in patients with refractory myelodysplastic syndromes.

Decitabine/cedazuridine, approved in July 2020, acts as a nucleoside metabolic inhibitor and showed comparable safety and efficacy to IV decitabine in the ASCERTAIN study, making it a viable treatment option for patients with intermediate or high-risk myelodysplastic syndromes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel agents for myelodysplastic syndromes. Xu, K., Hansen, E.[2022]

Luspatercept has recently been approved as a targeted therapy for treating anemia in myelodysplastic syndromes (MDS) patients who do not respond to erythropoiesis stimulating agents, marking a significant advancement in treatment options.

Ongoing research is focused on developing new targeted therapies that address myeloid lineage signaling pathways and the immune microenvironment, which could enhance treatment strategies for MDS as current options are limited after treatment failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting the Myeloid Lineages and the Immune Microenvironment in Myelodysplastic Syndromes: Novel and Evolving Therapeutic Strategies. Chung, C.[2022]

Recent breakthroughs in understanding myelodysplastic syndromes (MDS) include insights into the molecular genetics of the 5q- syndrome, which could lead to better-targeted therapies.

Evidence presented at the Annual Meeting of the American Society of Hematology indicates that hypomethylating agents provide a survival advantage for patients with high-risk MDS, highlighting their potential efficacy in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meeting report: myelodysplastic syndromes at ASH 2007. Itzykson, R., Gardin, C., Fenaux, P.[2018]

Citations

1.

ir.jaspertherapeutics.com

ir.jaspertherapeutics.com/news-releases/news-release-details/jasper-therapeutics-announces-jsp191-phase-1b-mdsaml-late

Jasper Therapeutics Announces JSP191 Phase 1b MDS ...

Furthermore, this regimen achieved engraftment with neutrophil recovery in all 17 of 17 subjects and clearance of MRD in 12 of 15 subjects ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04429191

JSP191 Antibody Conditioning Regimen in MDS/AML ...

This is a Phase 1a/b study to evaluate the safety and tolerability of an antibody conditioning regimen known as JSP191, in combination with low dose radiation ...

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.7035

Early results of phase 1 study of JSP191, an anti-CD117 ...

These early results are the first to demonstrate that JSP191/TBI/Flu is safe, well-tolerated, and capable of clearing MDS/AML MRD in older adults undergoing ...

4.

ir.jaspertx.com

ir.jaspertx.com/news-releases/news-release-details/jasper-therapeutics-announces-updated-data-phase-1-clinical

News Release Details

JSP191 is well tolerated with no treatment-related severe adverse events in 24 patients with myelodysplastic syndrome (MDS) or acute myeloid ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6509544/

Anti-CD117 antibody depletes normal and myelodysplastic ...

Depletion of low-risk MDS cells was sustained as determined by analyses performed at 12 weeks after AMG 191 treatment (Figure 2C). Taken together, these data ...

6.

withpower.com

withpower.com/trial/phase-1-preleukemia-5-2023-21ca8

JSP191 for Myelodysplastic Syndrome · Info for Participants

The provided research does not contain specific safety data for JSP191 or AMG 191 in the treatment of Myelodysplastic Syndrome. The studies focus on other ...