Orca-T for Blood Cancer

Recruiting at 3 trial locations

Overseen By Chief Medical Officer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Orca Biosystems, Inc.

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Prior alloHCT, Uncontrolled infections, 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

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Orca-T for individuals with certain blood cancers undergoing a donor stem cell transplant. The goal is to determine if Orca-T is safe and effective, as it uses special immune and stem cells from the donor to combat the cancer. Suitable candidates for this trial have specific types of leukemia or myelodysplastic syndrome and are planning a less intensive stem cell transplant. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the Orca-T trial?

The trial requires that you stop taking corticosteroids or other immunosuppressive therapies, except for topical corticosteroids or oral doses less than or equal to 10 mg/day. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that Orca-T is likely to be safe for humans?

Research has shown that Orca-T is generally safe for patients with blood cancers. Studies have found it to be a well-tolerated cell therapy for those needing a stem cell transplant. In one study, 94% of patients who received Orca-T remained alive after one year, indicating its effectiveness and safety compared to other treatments.

Orca-T also reduces chronic graft-versus-host disease (cGVHD), a common issue after transplants where donor cells attack the patient's body. This suggests that Orca-T may lead to fewer complications. While more research is needed, these findings are promising for the safety of Orca-T in treating blood cancer patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for blood cancer, which often involve chemotherapy and radiation, Orca-T is a cutting-edge therapy combining reduced-intensity conditioning (RIC) or non-myeloablative (NMA) conditioning with a targeted cell therapy approach. Researchers are excited about Orca-T because it uses engineered T cells designed to enhance immune response while minimizing the severe side effects typically associated with traditional treatments. This novel method has the potential to offer a more effective and less toxic alternative, which might improve outcomes and quality of life for patients with blood cancer.

What evidence suggests that Orca-T might be an effective treatment for blood cancer?

Studies have shown that Orca-T, the treatment tested in this trial, can significantly improve survival rates for people with blood cancers. One study found that patients who received Orca-T had a 94% chance of being alive after one year, compared to 83% for those who underwent a standard stem cell transplant from a donor. Orca-T also extended the time patients lived without developing chronic GVHD, a condition that can occur after a transplant. Specifically, after three years, 86% of patients with various blood cancers remained alive with Orca-T, compared to 67% in another group. These results suggest that Orca-T is a promising treatment option for blood cancer patients undergoing stem cell transplants. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with certain blood disorders and cancers, like acute myeloid leukemia or myelodysplastic syndrome. Participants will undergo a stem cell transplant and must meet specific health criteria not detailed here.

Inclusion Criteria

Diffusing capacity of the lung for carbon monoxide (adjusted for hemoglobin) ≥40%

Negative serum or urine β-HCG test in women of childbearing potential

ALT/AST <5 times the upper limit of normal (ULN)

Exclusion Criteria

HCT-Specific Comorbidity Index (HCT-CI) ≥6 for RIC cohort only

Known allergy or hypersensitivity to or intolerance of tacrolimus

Documented allergy or hypersensitivity to iron dextran or certain proteins

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning and Transplantation

Participants undergo reduced intensity or non-myeloablative conditioning followed by Orca-T transplantation

4 weeks

Multiple visits for conditioning and transplantation

Post-Transplant Monitoring

Participants are monitored for engraftment, GVHD, and other safety outcomes

4 weeks

Weekly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular visits for long-term follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Orca-T

Trial Overview The study tests Orca-T, an immunotherapy made from a donor's blood cells, in patients receiving less intense stem cell transplants to treat various hematologic conditions.

How Is the Trial Designed?

Group I: Orca-T Experimental Treatment 1 Intervention

Participants will receive \[RIC or NMA conditioning\] + Orca-T + single-agent tacrolimus based on eligibility and investigator's choice of conditioning regimen.

Who Is Running the Clinical Trial?

Orca Biosystems, Inc.

Lead Sponsor

Trials

8

Recruited

750+

Citations

1. orcabio.com orcabio.com/orca-bio-announces-positive-results-from-the-pivotal-phase-3-study-of-investigational-orca-t-compared-to-allogeneic-stem-cell-transplant-for-the-treatment-of-hematologic-malignancies/

Press release Patients in the Orca-T group achieved an estimated overall survival (OS) of 94% compared to 83% in the alloHSCT arm at one year. "Today, ...

2. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/3560/502299/Phase-1-Trial-Results-for-Patients-with-Advanced

Phase 1 Trial Results for Patients with Advanced Hematologic ... Conclusions: These early results demonstrate that Orca-T is a safe and feasible transplant strategy in the RIC setting for patients with ...

3. onclive.com onclive.com/view/orca-t-delivers-major-gains-beyond-conventional-prophylaxis-in-hematologic-malignancies

Orca-T Delivers Major Gains Beyond Conventional ... Orca-T showed superior chronic GVHD-free survival and overall survival compared with conventional prophylaxis in the Precision-T trial. Long- ...

4. orcabio.com orcabio.com/orca-bio-presents-three-year-survival-data-with-orca-t-in-patients-with-hematological-malignancies-at-the-66th-ash-annual-meeting/

Orca Bio Presents Three-Year Survival Data with Orca-T® ... Three-year overall survival with Orca-T allogeneic T-cell immunotherapy was 86% for patients with AML, ALL and MDS compared to 67% in a non-randomized ...

5. astctjournal.org astctjournal.org/article/S2666-6367(25)00453-1/fulltext

Phase 1 Trial Results for Patients with Advanced ... Conclusions. These early results demonstrate that an Orca-T is a safe and feasible alternative to conventional HSCT-RIC, with robust and early donor myeloid and ...

6. orcabio.com orcabio.com/orca-bio-to-present-new-clinical-data-on-its-high-precision-cell-therapies-at-the-67th-american-society-of-hematology-annual-meeting/

Orca Bio to Present New Clinical Data on Its High- ... Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including ...

7. cancernetwork.com cancernetwork.com/view/orca-t-displays-cgvhd-free-survival-benefit-in-hematologic-malignancies

Orca-T Displays cGVHD-Free Survival Benefit in ... Additionally, the estimated 1-year overall survival (OS) in the Orca-T group was 94% (95% CI, 86%-97%) vs 83% (95% CI, 73%-90%) with alloHSCT ( ...