OncoMatch/Clinical Trials/NCT05418088
Genetically Engineered Cells (Anti-CD19/CD20/CD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies
Is NCT05418088 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Anti-CD19/CD20/CD22 CAR T-Cells and Cyclophosphamide for recurrent acute lymphoblastic leukemia.
Treatment: Anti-CD19/CD20/CD22 CAR T-Cells · Cyclophosphamide · Fludarabine Phosphate — This phase I trial tests the safety, side effects and best infusion dose of genetically engineered cells called anti-CD19/CD20/CD22 chimeric antigen receptor (CAR) T-cells following a short course of chemotherapy with cyclophosphamide and fludarabine in treating patients with lymphoid cancers (malignancies) that have come back (recurrent) or do not respond to treatment (refractory). Lymphoid malignancies eligible for this trial are: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and B-prolymphocytic leukemia (B-PLL). T-cells (a type of white blood cell) form part of the body's immune system. CAR-T is a type of cell therapy that is used with gene-based therapies. CAR T-cells are made by taking a patient's own T-cells and genetically modifying them with a virus so that they are recognized by a group of proteins called CD19/CD20/CD22 which are found on the surface of cancer cells. Anti-CD19/CD20/CD22 CAR T-cells can recognize CD19/CD20/CD22, bind to the cancer cells and kill them. Giving combination chemotherapy helps prepare the body before CAR T-cell therapy. Giving CAR-T after cyclophosphamide and fludarabine may kill more tumor cells.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive by immunohistochemistry or flow cytometry
The patient's lymphoid malignancy must be positive for at least one target antigen (CD19 and/or CD20 and/or CD22), either by immunohistochemistry or flow cytometry analysis on the last biopsy available or peripheral blood for circulating disease.
Required: CD20 positive by immunohistochemistry or flow cytometry
The patient's lymphoid malignancy must be positive for at least one target antigen (CD19 and/or CD20 and/or CD22), either by immunohistochemistry or flow cytometry analysis on the last biopsy available or peripheral blood for circulating disease.
Required: CD22 positive by immunohistochemistry or flow cytometry
The patient's lymphoid malignancy must be positive for at least one target antigen (CD19 and/or CD20 and/or CD22), either by immunohistochemistry or flow cytometry analysis on the last biopsy available or peripheral blood for circulating disease.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BTK inhibitor — for CLL
Subjects with relapsed/refractory CLL after at least 2 prior lines of appropriate therapy and must have previously received an approved BTK inhibitor and venetoclax
Must have received: BCL2 inhibitor (venetoclax) — for CLL
Subjects with relapsed/refractory CLL after at least 2 prior lines of appropriate therapy and must have previously received an approved BTK inhibitor and venetoclax
Must have received: autologous stem cell transplant — for high-grade B-cell lymphoma
Subjects with refractory high-grade B-cell lymphoma who relapse within 12 months of autologous stem cell transplant
Must have received: allogeneic stem cell transplant — for relapsed/refractory B-prolymphocytic leukemia
Subjects with relapsed/refractory B-prolymphocytic leukemia who received at least 1-2 prior lines of appropriate therapy and who have failed or are ineligible for allogeneic stem cell transplant
Must have received: allogeneic stem cell transplant — for relapsed/refractory acute B-lymphoblastic leukemia
Subjects with relapsed/refractory acute B-lymphoblastic leukemia who received at least 2 prior lines of appropriate therapy or who have failed or are ineligible for allogeneic stem cell transplant.
Cannot have received: autologous stem cell transplant
Exception: within 6 weeks of planned CAR-T cell infusion
Autologous transplant within 6 weeks of planned CAR-T cell infusion
Cannot have received: allogeneic stem cell transplant
Exception: within 2 months of planned CAR-T cell infusion
Allogeneic stem cell transplant or donor lymphocyte infusion within 2 months of planned CAR-T cell infusion and patients must be off immunosuppressive agents.
Cannot have received: donor lymphocyte infusion
Exception: within 2 months of planned CAR-T cell infusion
Allogeneic stem cell transplant or donor lymphocyte infusion within 2 months of planned CAR-T cell infusion and patients must be off immunosuppressive agents.
Cannot have received: investigational agent
Exception: within 28 days prior to lymphocyte collection
A minimum of 28 days must have elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection
Cannot have received: live vaccine
Exception: within 28 days prior to lymphodepleting chemotherapy
Live vaccines given in 28 days prior to lymphodepleting chemotherapy
Lab requirements
Blood counts
Absolute lymphocyte count > 100/uL
Kidney function
Creatinine clearance >= 50 ml/min calculated by Cockcroft-Gault formula, or by Schwartz formula for patients < 18 years
Liver function
Total bilirubin <= 1.5 times the institutional upper limit of normal for age; AST <= 3 X institutional upper limit of normal for age; ALT <= 3 X institutional upper limit of normal for age
Cardiac function
Left ventricular ejection fraction >= 40% in the most recent echocardiogram
Total bilirubin <= 1.5 times the institutional upper limit of normal for age; AST <= 3 X institutional upper limit of normal for age; ALT <= 3 X institutional upper limit of normal for age; Creatinine clearance >= 50 ml/min calculated by Cockcroft-Gault formula, or by Schwartz formula for patients < 18 years; Absolute lymphocyte count > 100/uL; Left ventricular ejection fraction >= 40% in the most recent echocardiogram
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Nationwide Children's Hospital · Columbus, Ohio
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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