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About
This research study involves the study of TriPRIL CAR T Cells for treating people with relapsed or refractory multiple myeloma and to understand the side effects when treated with TriPRIL CAR T Cells.
This research study involves the study drugs:.
Full description
This is a two-part, non-randomized, open label, single-site Phase 1 study of TriPRIL CAR T Cells as a treatment for relapsed or refractory multiple myeloma.
This study consists of 2 parts:
TriPRIL CAR T Cells is an investigational treatment that uses a person's own immune cells, called T cells, to try to kill their cancerous cells. T cells fight infections and can also kill cancer cells in some cases. The U.S. Food and Drug Administration (FDA) has not approved TriPRIL CAR T Cells as a treatment for any disease.This is the first time that TriPRIL CAR T Cells will be given to humans.
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
Participants will receive one infusion of the study treatment and will be followed for up to 2 years.
It is expected that about 18 people will take part in this research study.
Enrollment
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Volunteers
Inclusion criteria
Ability to understand and the willingness to sign a written informed consent document.
Age ≥18 years at the time of signing informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Life expectancy of greater than 12 weeks
Histologically or cytologically confirmed diagnosis of relapsed/refractory multiple myeloma. Documented measurable disease includes at least one or more of the following criteria:
Relapsed/refractory multiple myeloma with at least 3 prior regimens of systemic therapy including proteasome inhibitor, IMiDs and anti-CD38 antibody; or has "triple-refractory" disease following treatment with proteasome inhibitor, IMiD and anti-CD38 antibody, as part of the same or different regimens.
Note: IMWG criteria defines refractory disease as disease progression on or within 60 days of receiving a therapy Note: Induction treatment with or without hematopoietic stem cell transplant and with or without maintenance is considered a single regimen.
Adequate organ and marrow function as defined below:
Resolution of AEs from any prior therapy to ≤ Grade 1 (≤ G2 alopecia and ≤ G2 sensory neuropathy are allowed, cytopenias allowed per eligibility criteria above)
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
The effects of TriPRIL CAR T cells on the developing human fetus are unknown. Male and female participants of childbearing potential must agree to use highly effective methods of birth control prior to study entry, for the duration of study participation, and through 6 months after completion of TriPRIL CAR T cells administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
NOTE: Highly effective contraception methods include:
Total abstinence
Female sterilization (tubal ligation, bilateral oophorectomy, and/or hysterectomy)
Male sterilization, at least 6 months prior to screening
Intrauterine device
Oral, injected, or implanted hormonal contraception AND barrier methods of contraception
Exclusion criteria
Treatment with any of the following therapies as specified below:
Plasma cell leukemia or history of plasma cell leukemia
Patients with extramedullary disease only without meeting criteria for measurable disease as per inclusion criteria above.
No Bispecific T cell engagers withing 6 months of apheresis
No bendamustine within 6 months of apheresis
Patients with solitary plasmacytomas without evidence of other measurable disease
History of allergic reactions attributed to compounds of similar chemical or biologic composition to CAR- T cells
Contraindication to the protocol-specified doses of fludarabine or cyclophosphamide
Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of ≤ G2 alopecia and grade ≤2 sensory neuropathy.
Active bacterial, viral, or fungal infection requiring systemic treatment (isolated fever may not constitute active infection in and of itself, e.g., related to disease)
Symptomatic congestive heart failure
Unstable angina, arrhythmia, or myocardial infarction (MI) within 6 months prior to screening
Significant pulmonary dysfunction
Auto-immune disease requiring immunosuppressive therapy
Pulmonary embolism or DVT within three months of enrollment or uncontrolled thromboembolic events. Therapeutic dosing of anticoagulants (e.g., warfarin, low molecular weight heparin, Factor Xa inhibitors) is allowed for history of DVT or PE if greater than three months from time of enrollment. Prophylactic anticoagulation is allowed.
Recent severe hemorrhage (within the past 60 days)
Seropositive for and with evidence of active hepatitis B or C infection at time of screening, or HIV seropositive
Active central nervous system (CNS) involvement by malignancy. NOTE: subjects who are asymptomatic, stable, and received prior effective treatment for CNS disease may be eligible after discussion with the medical monitor.
Any sign of active or prior CNS pathology including history of epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or CNS bleed, severe brain injury, dementia, cerebellar disease, Parkinson's disease, organic brain syndrome or psychosis.
Active malignancy not related to myeloma that has required therapy in the last 3 years or is not in complete remission. Exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy. Other similar malignant conditions may be discussed with and permitted by the medical monitor.
Females who are pregnant or breastfeeding or females of childbearing potential not using an effective method of birth control
Subjects with any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in study (or full access to medical records) as written including follow up, the interpretation of data or place the subject at unacceptable risk
Participants taking any other medicine concurrently that may interfere with the study (need to consult with the principle investigator)
Primary purpose
Allocation
Interventional model
Masking
18 participants in 2 patient groups
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Central trial contact
Matthew J Frigault, MD
Data sourced from clinicaltrials.gov
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