Status:
ACTIVE_NOT_RECRUITING
Precision-T: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
Lead Sponsor:
Orca Biosystems, Inc.
Conditions:
Acute Myeloid Leukemia
Acute Lymphoid Leukemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety, tolerability, and efficacy of Orca-T, an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobil...
Eligibility Criteria
Inclusion
- Key
- Recipients must meet all of the following criteria:
- Patients must diagnosed with one of the following histopathologically confirmed diseases, for which a myeloablative hematopoietic stem cell transplant (HCT) is planned:
- A) Acute myeloid, lymphoid, or mixed phenotype/undifferentiated leukemia who are not in CR or CRi (active disease) and/or MDS with \>10% to \<20% bone marrow blast burden (ages 18 to 75 years)
- B) Acute leukemia in CR/CRi or MDS that is DRI intermediate to high risk (ages 66 to 75 years)
- C) BPDCN (ages 18 to 65 years)
- D) Participants aged 18 to 65 who would be eligible for the Phase 3 component of Precision-T except for mild impairments of renal and/or hepatic function as defined by an eGFR of 50 to \<60 mL/min and/or a total bilirubin of \>ULN to ≤2 x ULN and diagnosed with either of the following:
- i. Acute myeloid, lymphoid, or mixed phenotype/undifferentiated leukemia that is in CR/CRi and DRI intermediate to high risk
- a) MDS that is DRI intermediate to high risk
- E) Acute or chronic leukemia in remission that is DRI low risk (ages 18 to 65 years), including the following:
- i. CML in chronic phase but with a history of accelerated phase or blast crisis or who are resistant to or intolerant of more than 1 first- and second-generation tyrosine kinase inhibitors
- ii. Acute myeloid leukemia (AML) with inv(16) without accompanying complex cytogenetics
- Patients must be matched to a 8/8 HLA-matched related or unrelated donor
- Estimated glomerular filtration rate (eGFR) \> 50 mL/minute
- Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA)
- Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%
- Total bilirubin \< 2 times upper limit of normal (ULN) (patients with Gilbert's syndrome may be included where hemolysis has been excluded) and ALT/AST \< 3 times ULN
- Key
Exclusion
- Recipients meeting any of the following exclusion criteria will not be eligible:
- History of prior allogeneic HCT
- Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed.
- Pre-planned donor lymphocyte infusion (DLI)
- Planned pharmaceutical in vivo or ex vivo T cell depletion
- Positive for anti-donor HLA antibodies against an allele in the selected donor
- Karnofsky performance score \< 70%
- Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) \> 4
- Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment
- Seropositive for HIV-1 or -2 antibody, HTLV-1 or -2 antibody, Hepatitis B sAg, or Hepatitis C antibody
- Any uncontrolled autoimmune disease requiring active immunosuppressive treatment
- Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected
- Women who are pregnant or breastfeeding
Key Trial Info
Start Date :
November 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT04013685
Start Date
November 21 2019
End Date
April 1 2027
Last Update
May 2 2025
Active Locations (21)
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1
City of Hope
Duarte, California, United States, 91010
2
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
3
UC Davis
Sacramento, California, United States, 95817
4
Stanford Health Care
Stanford, California, United States, 94305