Table 1.
Summary of Open and Planned Clinical Trials with CD19-Targeted Chimeric T Cell
| Cell Source | Patient Population | Trial Design | Accompanying Lymphodepleting Cytotoxic Therapy |
Trial Status |
Trial Site |
|---|---|---|---|---|---|
| Autologous T cells |
Relapsed or refractory CLL | Phase I dose-escalation trial | Cy | Open | US, New York |
| Autologous T cells |
Relapsed or refractory, or MRD+ ALL |
Phase I dose-escalation trial | Cy | Open | US, New York |
| Autologous T cells |
MRD+ or residual disease following frontline CLL therapy |
Phase I dose escalation trial; consolidation therapy following upfront chemotherapy |
Cy | Open | US, New York |
| Autologous T cells |
Relapsed or refractory low- intermediate grade NHL & CLL |
Phase I dose escalation trial | None | Open | US, Texas |
| Autologous T cells |
Relapsed or refractory B-cell leukemia/lymphoma (ALL, CLL, FL, MCL, DLBCL) |
Phase I dose escalation trial | None | Open | US, Pennsylvania |
| Autologous T cells |
Relapsed or refractory FL | Phase I | Fludarabine + rituximab |
Open | US, California |
| Autologous T cells |
CD19-expressing B cell malignancy of any type |
Phase I | Fludarabine + Cy | Open | US, NIH |
| Autologous T cells |
Relapsed or refractory low- intermediate grade NHL & CLL |
Phase I; modified T cell infusion following autologous-HSCT |
Autologous HSCT regimen (carmustine, etoposide, cytarabine, melphalan, rituximab) |
Open | US, Texas |
| Donor-derived EBV-specific T cells |
MRD+ or relapsed ALL following allo-HSCT |
Phase I dose escalation trial | Cy | Open | US, New York |
| Donor-derived multivirus- specific T cells |
Relapsed B-ALL following allo-HSCT |
Phase I dose-escalation trial | None | Open | US, Texas |
| Donor-derived T cells |
Relapsed B-cell leukemia/lymphoma following allo-HSCT |
Phase I dose-escalation trial | N/A | Open | US, NIH |
| UCB-derived T cells |
Relapsed or refractory ALL, NHL, SLL, CLL |
N/A | N/A | Pending | US, Texas |
| Autologous T cells |
High-risk, intermediate- grade NHL |
Phase I/II trial; modified T cell infusion following auto- HSCT |
N/A | Pending | US, California |
| Donor-derived EBV-specific T cells |
High-risk or relapsed B-ALL after allo-HSCT |
Phase I | N/A | Pending | Europe (France, Germany, Italy, UK) |
CLL: chronic lymphocytic leukemia; Cy: cyclophosphamide; MRD: minimal residual disease; ALL: acute lymphocytic leukemia; NHL: non-Hodgkin’s lymphoma; FL: follicular lymphoma; MCL: mantle cell lymphoma; DLBCL: diffuse large B cell lymphoma; HSCT: hematopoietic stem cell transplant; SLL: small lymphocytic lymphoma