Adoptive Cell Therapy for B-Cell Cancers in Patients After Stem Cell Transplantation

Inclusion Criteria

• •Recipient
• •1. Patients must have received allogeneic HSCT for B-cell malignancies (BCL), specifically Hodgkin s and non-Hodgkin s lymphomas, chronic lymphocytic leukemias, non T-cell acute lymphoblastic leukemia (B-cell ALL), or multiple myeloma, and must have persistent disease that has failed to respond after a minimum of four weeks to:
• •2. Donor Engraftment Status: Patients must have had evidence of stable or increasing donor engraftment over the preceding three months and at least 50% donor chimerism in the bone marrow, whole blood and/or circulating CD3+ lymphoid pool.
• •3. A trial of withdrawal of immunosuppressive therapy, including trials that are discontinued due to development of GVHD
• •4. Receiving at least one DLI with a minimum T cell dose of 1 x 10(7) CD3+ cells/kg.
• •* Patients who have persistent cancer after treatment with an alternative donor alloHSCT (e.g., haploidentical, matched unrelated, umbilical cord blood) or any patient for whom a donor cell product is unavailable and/or timely donor collection is not feasible may be included without failing DLI.
• •* Presence of bone marrow involvement with tumor and/or at least one resectable lymph node or other tumor focus that is a minimum of 1.5 cm(3) (estimated size from which at least 1.0 x 106 TNC/kg can be generated):
• •5. Resectable defined on a case-by-case basis, in collaboration with the Surgical Consult Service.
• •6. For surgical tumor resection, the expected procedure must be associated with minimal morbidity and minimal hospitalization.
• •7. In addition to a resectable lesion, there must be at least one other site of disease that permits monitoring for response to therapy.
• •8. Patients must be 18 75 years of age.
• •9. ECOG performance status less than or equal to 2 (Karnofsky performance status greater than or equal to 60%).
• •10. Life expectancy \> 3 months.
• •11. Minimal to no clinical evidence (Grade 0 to 1) of acute GVHD or limited-stage chronic GVHD while off of systemic immunosuppressive therapy for at least four weeks. Subjects who require continued prophylaxis with steroid-sparing agents, e.g.,cyclosporine, or whose disease is controlled with local therapy, e.g., topical steroids or budesonide, will be eligible for enrollment.
• •12. Provision for a Durable Power of Attorney.
• •13. Ability to give informed consent.
• •1.4 Eligibility of Recipients is not contingent upon enrollment of the donor.
• •Donor
• •Note: Donor enrollment is not required to meet the primary objectives of this protocol and will not affect eligibility of recipients.
• •1. Donor must be the same individual whose cells were used as the source for the patient s original stem cell transplant
• •2. Adequate venous access for peripheral apheresis, or consent to use a temporary central venous catheter for apheresis.
• •3. Donors must be HIV negative, hepatitis B surface antigen negative, and hepatitis C antibody negative.