A Phase I Trial of Donor- Derived 19-28z CAR T Cells Following Allogeneic Transplant for the Treatment of CD19 Malignancies
NCT ID: NCT04556266
Last Updated: 2025-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2021-07-01
2022-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort -1
Cohorts of 3-6 patients each will be treated with escalating doses of consolidative modified T cells at Day 30 (+/- 5 days) post allo-HSCT
Total T-Cell Dose: 1 x 10\^4 cells/kg
CAR T-Cell Infusion
Dose Level -1: 1 x 10\^4 cells/kg Dose Level 1: 1 x 10\^5 cells/kg Dose Level 2: 2 x 10\^5 cells/kg Dose Level 3: 4 x 10\^5 cells/kg
Cohort 1
Cohorts of 3-6 patients each will be treated with escalating doses of consolidative modified T cells at Day 30 (+/- 5 days) post allo-HSCT
Total T-Cell Dose: 1 x 10\^5 cells/kg
CAR T-Cell Infusion
Dose Level -1: 1 x 10\^4 cells/kg Dose Level 1: 1 x 10\^5 cells/kg Dose Level 2: 2 x 10\^5 cells/kg Dose Level 3: 4 x 10\^5 cells/kg
Cohort II
Cohorts of 3-6 patients each will be treated with escalating doses of consolidative modified T cells at Day 30 (+/- 5 days) post allo-HSCT
Total T-Cell Dose: 2 x 10\^5 cells/kg
CAR T-Cell Infusion
Dose Level -1: 1 x 10\^4 cells/kg Dose Level 1: 1 x 10\^5 cells/kg Dose Level 2: 2 x 10\^5 cells/kg Dose Level 3: 4 x 10\^5 cells/kg
Cohort III
Cohorts of 3-6 patients each will be treated with escalating doses of consolidative modified T cells at Day 30 (+/- 5 days) post allo-HSCT
Total T-Cell Dose: 4 x 10\^5 cells/kg
CAR T-Cell Infusion
Dose Level -1: 1 x 10\^4 cells/kg Dose Level 1: 1 x 10\^5 cells/kg Dose Level 2: 2 x 10\^5 cells/kg Dose Level 3: 4 x 10\^5 cells/kg
Interventions
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CAR T-Cell Infusion
Dose Level -1: 1 x 10\^4 cells/kg Dose Level 1: 1 x 10\^5 cells/kg Dose Level 2: 2 x 10\^5 cells/kg Dose Level 3: 4 x 10\^5 cells/kg
Eligibility Criteria
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Inclusion Criteria
1. ALL in second remission or greater (≥ CR2)
* Please refer to section 3.0 for more discussion of ALL in CR1 versus CR2
2. CLL
1. High risk in any remission status as defined by 17p deletion or Richter's transformation, or
2. All other patients eligible after at least 2 lines of standard or investigational chemotherapy
3. B-NHL
1. Refractory or stable disease to last line of therapy per ICML 2014. Patients should have at least 2 lines of prior therapy.
2. Relapsed disease in patients who are not candidates for autologous transplant
4. Patient's age is ≥ 18 and ≤ 60.
5. KPS ≥ 70%
6. Patients must have CD19 expression (by any detection method) demonstrated on their malignant cells at the time of enrollment on the protocol.
7. Patients relapsed after prior CD19 CAR T cell or blinatumomab are eligible for enrollment as long as CD19 expression is still prese on the malignant cells.
8. Patients who have a matched related donor willing to donate HSC for allograft and PBMC for CAR T cell generation
9. Patients must have adequate organ function measured by:
1. Cardiac: asymptomatic or if symptomatic then LVEF at rest must be \> 50%
2. Hepatic: \< 3x ULN ALT and \< 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
3. Renal: serum creatinine \<1.3 mg/dl or if serum creatinine is outside the normal range, then CrCl \> 60 ml/min (measured or calculated/estimated)
4. Pulmonary: asymptomatic or if symptomatic, DLCO \> 50% of predicted (corrected for hemoglobin)
5. Negative serum pregnancy test for women of child-bearing potential is required
Exclusion Criteria
2. Patients who have undergone a prior allogeneic or autologous stem cell transplant within the previous six months.
3. Pregnant or breast feeding
4. HIV infection
5. Progressive disease at time of transplant
6. Patients with known autoimmune disease.
7. Patients with active or clinically significant neurological disorders, such as seizure disorders.
18 Years
60 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Miguel-Angel Perales, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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17-331
Identifier Type: -
Identifier Source: org_study_id
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