CAR T-cell Therapy

Subjects with Acute Leukemia or Myelodysplasic Syndrome, Myelofibrosis, or BPDCN for Chronic Myeloid Leukemia

Memorial Sloan Kettering Cancer Center, New York, NY

Targeting 6 different conditionsOrca-T (formerly TregGraft)Phase 1RecruitingResearch Sponsored by Orca Biosystems, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Blastic Plasmacytoid Dendritic Cell Neoplasm [Ages 18-65]

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up365 days

Awards & highlights

No Placebo-Only Group

Study Summary

This trial will test a new type of transplant that may be safer and more effective than the current standard.

Eligible Conditions

Chronic Myeloid Leukemia
Myelodysplastic Syndrome
Acute Leukemia
Acute Lymphoblastic Leukemia
Blastic Plasmacytoid Dendritic Cell Neoplasm
Acute Myeloid Leukemia

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You have a rare type of cancer called Blastic Plasmacytoid Dendritic Cell Neoplasm and you are between the ages of 18 and 65.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 365 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~365 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

TregGraft (Orca-T), with single agent GVHD prophylaxis

Secondary outcome measures

1 year graft-versus-host-disease-free and relapse-free survival (GRFS)

1-year overall survival (OS)

incidence and severity of acute and chronic graft vs host disease (GvHD)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Subjects with Acute Leukemia or Myelodysplasic Syndrome, Myelofibrosis, or BPDCNExperimental Treatment1 Intervention

This is a non-randomized, single-arm study. All enrolled subjects will receive an allogeneic HCT with the Orca-T product.

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

Orca Biosystems, Inc.Lead Sponsor

5 Previous Clinical Trials

442 Total Patients Enrolled

Media Library

Orca-T (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04013685 — Phase 1

Chronic Myeloid Leukemia Research Study Groups: Subjects with Acute Leukemia or Myelodysplasic Syndrome, Myelofibrosis, or BPDCN

Chronic Myeloid Leukemia Clinical Trial 2023: Orca-T Highlights & Side Effects. Trial Name: NCT04013685 — Phase 1

Orca-T (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04013685 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are applicants over the age of 45 being considered for participation in this research?

"The recruitment criteria for this trial require that prospective participants are at least 18 years of age and not yet 75."

Answered by AI

Is enrollment still available for this research endeavor?

"Affirmative. The public-facing clinicaltrials.gov page states that this investigation is still open for recruitment of participants, with the initial post having been published on November 21st 2019 and last updated October 18th 2022. This trial requires 255 patients to be enrolled from 14 different sites."

Answered by AI

What are the risk profiles associated with TregGraft (Orca-T) treatment?

"Considering the limited data on safety and efficacy, our team at Power has assigned TregGraft (Orca-T) a score of 1."

Answered by AI

How many sites are involved in carrying out this experiment?

"14 sites are currently enrolling for this trial, including University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center in Miami, Weill Cornell Medicine - New York-Presbyterian Hospital in New York, and Winship Cancer Institute - Emory University in Atlanta. Other locations may also be available."

Answered by AI

Do any particular demographics make for ideal study candidates in this trial?

"This clinical trial, which is recruiting 255 participants between 18-75 years of age that have myelodysplastic syndromes (MDS), has particular criteria for enrolment. These include having acute myeloid, lymphoid or mixed phenotype leukemia that isn't in CR/CRi (Ages 18-65); being categorized as DRI very high risk with the same condition(Ages 18-65); Myelofibrosis sufferers(18-65) and Blastic Plasmacytoid Dendritic Cell Neoplasms patients (18- 65). Furthermore, those aged 66 to 75 must possess"

Answered by AI

How many participants have been selected to take part in this trial?

"To satisfy the study's requirements, 255 participants who meet the stated inclusion criteria must enroll. These individuals can seek enrollment in medical facilities such as University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center located in Florida, or Weill Cornell Medicine - New York-Presbyterian Hospital found in Georgia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Engineered Donor Grafts (Orca-T) in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

2019. "A Study of Engineered Donor Grafts (Orca-T) in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04013685.