Trial studying safety and effects for Hematologic Malignancy
Official title Feasibility and Safety of Collecting and Combining Autologous Hematopoietic Stem Cells With Chimeric Antigen Receptor (CAR) T-Cell Therapy in Subjects With Relapsed/Refractory Hematological Malignancies
ClinicalTrials.gov ID: NCT05887167
What this study is testing
What is Autologous Hematopoietic Stem Cells Added to Planned CAR T?
An investigational therapy being studied for patients with relapsed or refractory hematologic malignancies.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see if it is possible to collect enough stem cells from at least half of the participants and whether the combined treatment causes serious side effects in the first two months after therapy.
- Who it's for
- It is looking for adults with relapsed or refractory blood cancers such as large B‑cell lymphoma, acute lymphoblastic leukemia, mantle cell lymphoma, multiple myeloma, or diffuse large B‑cell lymphoma.
- What's involved
- Participants will give a stem cell sample, receive CAR T‑cell therapy, and then be monitored for side effects and response to treatment. They will have regular medical visits and tests to track safety and effectiveness.
- Time commitment
- The study lasts about two months after treatment, with several clinic visits and tests during that period.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Age 18 - 85 years.
- Histologically proven hematological malignancy according to the World Health Organization 2016 classification criteria for which a commercially...
- 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...
You likely can't join if
- 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...
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months...
- 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...
See the full eligibility 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.
- 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.
- people 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.
- 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.
- 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.
- people 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.