TriPRIL CAR T Cells in Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Jan 1, 2028
  • participants needed
    18
  • sponsor
    Marcela V. Maus, M.D.,Ph.D.
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Updated on 24 November 2025
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Summary

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:.

  • TriPRIL CAR T Cells
  • Fludarabine and Cyclophosphamide: Standardly used chemotherapy drugs as part of lymphodepleting process

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:

  • Part A (Dose Escalation) : The investigators are looking to find the highest dose of the study intervention that can be administered safely without severe or unmanageable side effects, not everyone who participates in this research study will receive the same dose of the study intervention. The dose given will depend on the number of participants who have been enrolled prior and how well the dose was tolerated Once determined, this highest dose will then be used in the dose expansion part of the study.
  • Part B (Expansion Cohort):Participants will be treated at the respective dose as determined during Part A (Dose Escalation).

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.

Details
Condition Multiple Myeloma, Multiple Myeloma in Relapse, Refractory Multiple Myeloma
Age 18years or above
Clinical Study IdentifierNCT05020444
SponsorMarcela V. Maus, M.D.,Ph.D.
Last Modified on24 November 2025

Eligibility

 Yes No Not Sure

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
Serum M-protein ≥1.0 g/dL
Urine M-protein ≥200 mg/24 hours
Involved serum free light chain ≥100 mg/L with abnormal κ/λ ratio
Bone marrow plasma cells ≥30%
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
O2 saturation ≥92% on room air while awake
LVEF ≥40% by ECHO or MUGA scan
ANC ≥1.0k/μl, PLT ≥50k/μl, (NOTE: Platelet transfusion not allowed within 7 days; growth factor neupogen not allowed within 7 days, neulasta within 14 days)
Creatinine clearance ≥30 mL/min and not on dialysis
AST/ALT <3 x ULN
Direct bilirubin <1.5 x ULN (allow x 3 ULN for Gilbert's syndrome)
PTT, PT/INR <1.5 x ULN, unless on a stable dose of anti-coagulant for a thromboembolic event (Patients with any history of thromboembolic stroke; or history or Grade 2 or greater hemorrhage within 60 days are excluded)
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
Willing to comply with and able to tolerate study procedures, including Long-term Safety Follow-up lasting up to 15 years per FDA guidance

Exclusion Criteria

Treatment with any of the following therapies as specified below
Any prior systemic treatment for multiple myeloma within the 14 days prior to scheduled leukapheresis unless discussed with the medical monitor
Receiving high-dose (e.g., >10 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to leukapheresis
Autologous stem cell transplantation within 3 months prior to leukapheresis
Any prior allogeneic stem cell transplantation
Other CAR-T cell therapy within 6 months of leukapheresis
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
Subjects with a history of hepatitis B but have received antiviral therapy and have non-detectable viral DNA for 6 months are eligible
Subjects seropositive because of hepatitis B virus vaccine with no signs or active infection are eligible
Subjects who had hepatitis C but have received antiviral therapy and show no detectable HCV viral RNA for 6 months are eligible
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)
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