JSP191 for Myelodysplastic Syndrome

No longer recruiting at 1 trial location
DH
ML
HP
Overseen ByHarold Pestana
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Jasper Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12356

Who Is on the Research Team?

MD

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.
See 3 more

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.
See 3 more

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?
1Treatment groups
Experimental Treatment
Group I: JSP191Experimental Treatment1 Intervention

Find a Clinic Near You

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

Citations

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 ...
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 ...
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 ...
News Release DetailsJSP191 is well tolerated with no treatment-related severe adverse events in 24 patients with myelodysplastic syndrome (MDS) or acute myeloid ...
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 ...
JSP191 for Myelodysplastic Syndrome · Info for ParticipantsThe provided research does not contain specific safety data for JSP191 or AMG 191 in the treatment of Myelodysplastic Syndrome. The studies focus on other ...
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