Collecting and Combining Autologous Hematopoietic Stem Cells With (CAR) T-Cell Therapy in Hematological Malignancies

What is the Purpose of this Study?

The purpose of this study is to assess the impact of adding blood stem cells to CAR T-cell therapy in an effort to improve cancer treatment. CAR T-cell therapy is a type of treatment in which a patient's T-cells (a type of immune cell) are changed in the laboratory so that they attack cancer cells. T-cells are taken from a patient’s blood, and the gene for a special receptor that binds to a certain protein on the patient’s cancer cells is added to the T-cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of CAR T-cells are grown in the laboratory and given to the patient by infusion. CAR T-cell therapy requires chemotherapy prior to treatment. Participants in this study are patients who are eligible to receive one of the current CAR T-cell therapies approved by the U.S. Food and Drug Administration (FDA) for relapsed or refractory B-cell acute lymphoblastic leukemia, non-Hodgkin lymphoma, or multiple myeloma. The FDA has approved CAR T-cell therapy for the treatment of certain cancers, but its use in this study is considered to be investigational. During this study, more CAR T-cell therapies may become FDA-approved and available for use.


Eligibility

  • Age 18 - 85 years.
  • Histologically proven hematological malignancy according to the World Health Organization 2016 classification criteria for which a commercially available, FDA-approved CAR T product exists.
  • Relapsed or refractory disease, defined by the following:
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Where can I participate?

Cedars-Sinai Cancer at SOCC : Amy Oppenheim

More about this Clinical Trial

What is the full name of this clinical trial?

CSMC: A Phase 1 Single-arm, Open-label Study to Evaluate the Feasibility and Safety of Collecting and Combining Autologous Hematopoietic Stem Cells with Chimeric Antigen Receptor T-Cell Therapy in Subjects with Relapsed/Refractory Hematological Malignancies

Study Details
Disease Type/Condition

Hodgkin's Lymphoma, Leukemia, not otherwise specified, Leukemia, other, Lymphoid Leukemia, Multiple Myeloma, Myeloid and Monocytic Leukemia, Other Hematopoietic

Principal Investigator

Sasine, Joshua

Co-Investigators

Akil Merchant, David Oveisi, Hannah Lee, Justin Darrah, Leslie Ballas, Noah Merin, Robert Vescio, Ronald Paquette

Age Group

Adult

Phase

I

IRB Number

STUDY00002743

ClinicalTrials.gov ID

NCT05887167

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Amy Oppenheim

Phone
+1 310-423-3713
Email
amy.oppenheim@cshs.org
Study Detail
Disease Type/Condition

Hodgkin's Lymphoma, Leukemia, not otherwise specified, Leukemia, other, Lymphoid Leukemia, Multiple Myeloma, Myeloid and Monocytic Leukemia, Other Hematopoietic

Principal Investigator

Sasine, Joshua

Age Group

Adult

Phase

I

IRB Number

IIT2022-04-SASINE-CAR-T

ClinicalTrials.gov ID

NCT05887167

Key Eligibility
ClinicalTrials.gov

Contact
Name

Amy Oppenheim

Phone
+1 310-423-3713
Email
amy.oppenheim@cshs.org