Combining stem cell collection with CAR T-cell therapy for blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the feasibility and safety of collecting autologous hematopoietic stem cells (HSCs) to be used alongside CAR T-cell therapy in patients with relapsed or refractory hematological malignancies. It will assess whether at least 50% of enrolled patients can successfully provide the target dose of HSCs and monitor the safety of the combined treatment by tracking the incidence of cytokine release syndrome and neurotoxicity. The study will enroll 20 subjects and follow an open-label, single-center design to gather preliminary data on the effectiveness and safety of this approach.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Joshua Sasine, MD, PhD — Cedars-Sinai Medical Center
• Study coordinator: Clinical Trial Recruitment Navigator
• Email: GroupCancerTrialInformation@cshs.org
• Phone: 310-423-5842

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.