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:

Inclusion Criteria:

* 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:
* Disease progression after last regimen, or
* Refractory disease: failure to achieve a partial response (PR) or complete remission (CR) to the last regimen
* At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy for the malignancy at the time the subject is planned for leukapheresis.
* Toxicities due to prior therapy must be stable or recovered to ≤ Grade 1 with the exception of alopecia.
* Subjects with an active uncontrolled infection should not start CAR T treatment until the infection has resolved.
* Eastern cooperative oncology group (ECOG) performance status 0 - 2.
* Adequate hematologic, hepatic, and cardiac function
* Serum pregnancy test for women of childbearing potential (WOCBP) at Screening.
* Willing to comply to research specimen collection as specified in the protocol.
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Autologous hematopoietic cell transplant intent or execution within 8 weeks of planned CAR T infusion.
* History of allogeneic cell transplantation within 8 weeks of planned CAR T infusion.
* Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management at time of screening.
* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment.
* History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, or any autoimmune disease with CNS involvement.
* Doses of corticosteroids of greater than or equal to 5 mg/day of prednisone or equivalent doses of other corticosteroids and other immunosuppressive drugs are not allowed prior to enrollment. A washout period of 10 days prior to leukapheresis and 10 days prior to anti-CD19 CAR T cell administration is required.
* Any medical condition likely to interfere with assessment of feasibility or safety of study treatment.
* Live vaccine ≤ 6 weeks prior to planned start of conditioning regimen.
* History of severe immediate hypersensitivity reaction to any of the agents used in this study.
* Current pregnancy or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
* Subjects of both sexes who are not willing to practice birth control from the time of consent through 6 months after the completion of conditioning chemotherapy. Females who have undergone surgical sterilization or who have been postmenopausal for at least 1 year are not considered to be of childbearing potential.
* In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.
* Patients with obvious myeloid clonal hematopoiesis on the screening bone marrow biopsy will be excluded based on the risk of developing myeloid neoplasms with aHSC infusion.

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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Emilie Douine-Barthelemy, Emilie Douine-Barthelemy, Emilie Douine-Barthelemy

More about this Clinical Trial

What is the full name of this clinical trial?

IIT2022-04-SASINE-CAR-T: 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 Lymphoma, Leukemia, not otherwise specified, Leukemia, other, Lymphoid Leukemia, Multiple Myeloma, Myeloid and Monocytic Leukemia, Non-Hodgkin Lymphoma, Other Hematopoietic

Principal Investigator

Sasine, Joshua

Co-Investigators

Akil Merchant, David Oveisi, Hannah Lee, Hitomi Hosoya, Justin Darrah, Lawrence Liu, Leslie Ballas, Noah Merin, Ronald Paquette

Age Group

Adult

Phase

IRB Number

STUDY00002743

ClinicalTrials.gov ID

NCT05887167

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

Email

[email protected]