Myeloablative Conditioning Orca-T & Allogeneic Donor-Derived CD19/CD22-CAR TCells in B-Cell ALL (NCT05507827) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Myeloablative Conditioning Orca-T & Allogeneic Donor-Derived CD19/CD22-CAR TCells in B-Cell ALL
United States22 participantsStarted 2022-08-18
Plain-language summary
To assess the safety of administering allogenic, donor-derived CD19/CD22-CAR T cells that meet established release specifications in adults with B-cell ALL following a myeloablative conditioning regimen and Orca-T to determine if this will augment graft versus leukemia without increasing acute GVHD or graft failure.
Who can participate
Age range18 Years – 65 Years
SexALL
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Patient Inclusion Criteria:
* Subjects in CR must have a history of chemotherapy refractory disease defined as progression or stable disease after one line of chemotherapy, or relapsed disease after achieving prior CR OR must have other high risk ALL features including: CRLF2 rearrangement, Ph-like phenotype, MLL/KMT2a rearrangement, or hypodiploid karyotype.
* Subjects with persistent or relapsed minimal residual disease (MRD) (by flow cytometry, PCR, FISH, or next generation sequencing) require verification of MRD in the peripheral blood or bone marrow on two occasions at least 2 weeks apart.
* Subjects with active ALL (defined as \>=5% bone marrow blasts, circulating blasts, or extramedullary disease) are eligible.
* Age ≥ 18 and ≤ 65 years (i.e., from age 18 to \< 66 years old) at the time of enrollment
* Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2; or Karnofsky ≥ 60%
* CD19 expression is required any time since diagnosis. CD19 expression may be detected by immunohistochemistry or by flow cytometry. The choice of whether to use flow cytometry or immunohistochemistry will be determined by what is the most easily available tissue sample in each subject. In general, immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood and bone marrow samples. Patients receiving prior CD19 CAR T cell or blinatumomab are eligible if there is no documented history of CD19 negativity on the malignant cells.
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What they're measuring
1
Number of patients who received donor CD19/CD22-CAR T cells
Timeframe: 42 days
2
Assessment of the donors safety CD19/CD22-CAR T cells plus the Orca-T graft