Know Cancer

or
forgot password

A Phase 1 Dose Escalation Study of Infusion of ex Vivo cd3/cd28 Costimulated Umbilical Cord Blood-derived t Cells in Adults Undergoing Transplantation for Advanced Hematologic Malignancies


Phase 1
21 Years
50 Years
Open (Enrolling)
Both
CML, AML, MDS, ALL, NHL, Multiple Myeloma, Hodgkin's Disease

Thank you

Trial Information

A Phase 1 Dose Escalation Study of Infusion of ex Vivo cd3/cd28 Costimulated Umbilical Cord Blood-derived t Cells in Adults Undergoing Transplantation for Advanced Hematologic Malignancies


The main study intervention includes CD3/CD28 ex vivo costimulated T cells derived from a
thawed umbilical cord blood unit, co-infused following a myeloablative conditioning regimen.

Activated T cells are T cells that have been activated in the laboratory by exposure to 2
compounds or molecules called CD3 and CD28; when T cells are exposed to both of these
compounds at the same time, they become activated or "stimulated" and may be more effective
in fighting infections, cancer cells, and promoting the recovery of red cells, white cells,
and platelets after transplantation. At the Hospital of the University of Pennsylvania,
activated T cells are prepared at the Clinical Cell and Vaccine Production Facility, also
known as the CVPF.

Inclusion Criteria


Inclusion Criteria.

- Relapsed or persistent advanced hematologic malignancy; incurable with standard
chemotherapy and eligible for allogeneic HSCT, including:

- CHRONIC MYELOGENOUS LEUKEMIA (CML). Subjects in accelerated or blast phase or
subjects in chronic phase with inadequate response to Imatinib or intolerant to
Imatinib.

- ACUTE MYELOGENOUS LEUKEMIA (AML). Subject with high risk disease in first complete
remission (CR). High risk disease includes the following cytogenetic abnormalities:
monosomy 7, deletion 5, trisomy 8, inversion 3, t(3;3), t(6;9), or t(6;11). Subjects
with complex cytogenetic abnormalities (more than 3 chromosomal abnormalities).

- ACUTE MYELOGENOUS LEUKEMIA (AML). Subjects with diagnosis of AML after receiving
chemotherapy, radiation therapy or biopsy showing myelodysplastic syndrome.

- ACUTE MYELOGENOUS LEUKEMIA (AML). Subjects with persistent AML after 2 cycles of
standard induction chemotherapy.

- ACUTE MYELOGENOUS LEUKEMIA (AML). Subjects in first complete remission.

- MYELODYSPLASTIC SYNDROME (MDS). Subjects with intermediate or high risk disease based
upon International Prognostic Scoring System.

- ACUTE LYMPHOBLASTIC LEUKEMIA (ALL). Subjects with Philadelphia Chromosome (have
t(9;22) cytogenetic abnormality) or molecular documentation for BCR-ABL
translocation.

- ACUTE LYMPHOBLASTIC LEUKEMIA (ALL). Subjects with primary refractory disease or
subjects in 1st complete remission.

- NHL or HODKIN'S DISEASE. Subjects who relapse following autologous Stem Cell
Transplant.

- INDOLENT NHL. Subjects with progressive disease following > 2 regimens.

- MULTIPLE MYELOMA. Subjects who relapse following following autologous Stem Cell
Transplant.

- Adults age 21-50.

- Expected survival 4 weeks.

- Subjects with no suitable related or unrelated donor for Stem Cell Transplant.

- Subject has suitable Umbilical Cord Blood (UCB) unit available.

- Subject has: Ejection fraction > 45%; DLCO.45% predicted; Creatinine < 2; Total
bilirubin < 2X normal; Transaminases < 2X normal.

- Subject is capable of giving informed consent.

Exclusion Criteria:

- Subject is pregnant or lactating.

- Subject has an uncontrolled infection.

- Subject has an active or untreated disease involving the central nervous system.

- Subject has an active or uncontrolled medical condition that would preclude
participation in the protocol.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose limiting toxicity (DLT) is defined as grade 4 acute GVHD within the first 90 days following infusion.

Outcome Time Frame:

90 Days post Transplant

Safety Issue:

Yes

Principal Investigator

David Porter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pennsylvania

Authority:

United States: Food and Drug Administration

Study ID:

UPCC 02707

NCT ID:

NCT00891592

Start Date:

January 2009

Completion Date:

January 2013

Related Keywords:

  • CML
  • AML
  • MDS
  • ALL
  • NHL
  • Multiple Myeloma
  • Hodgkin's Disease
  • AML
  • MDS
  • ALL
  • NHL
  • Multiple Myeloma
  • Hodgkin's
  • Hodgkin Disease
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms

Name

Location

University of PennsylvaniaPhiladelphia, Pennsylvania  19104