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TriPRIL CAR T Cells in Multiple Myeloma

ConditionsMultiple MyelomaMultiple Myeloma in RelapseRefractory Multiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarcela V. Maus, M.D.,Ph.D.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • TriPRIL CAR T Cells

    Drug

    Intravenous infusion

  • Cyclophosphamide

    Drug

    Intravenous infusion

  • Fludarabine

    Drug

    Intravenous infusion

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: TriPRIL CAR T Cells-Dose EscalationExperimental treatment 3 interventions
Group B: TriPRIL CAR T Cells-Dose ExpansionExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs)

Study-related adverse events (AEs) will be listed and tabulated by type and study cohort. The rate of AEs in all infused patients, both within study cohorts and overall, will be calculated and reported with exact 95% confidence intervals. A separate safety analysis will report similar information within patients infused at the target dose of 1x108 or 3x108 TriPRIL CAR T cells.

Time frame
Week 24 post dosing, and every three months until two years.
2

Incidence of Dose Limiting Toxicity (DLT)

Dose-limiting toxicities will be listed and tabulated by type and study cohort.

Time frame
Week 24 post dosing, and every three months until two years.

Secondary outcomes

1

Overall Response Rate (ORR)

Data will be listed, tabulated, and presented descriptively using Kaplan Meier plots.

Time frame
1 month, 6 months, 12 months, and 24 after CAR T cell treatment.
2

Overall Survival (OS)

Data will be listed, tabulated, and presented descriptively using Kaplan Meier plots.

Time frame
1 month, 6 months, 12 months and 24 months after CAR T cell treatment.
3

Progression Free Survival (PFS)

Data will be listed, tabulated, and presented descriptively using Kaplan Meier plots.

Time frame
1 month, 6 months, 12 months and 24 months after CAR T cell treatment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marcela V. Maus, M.D.,Ph.D.

Lead sponsor

Massachusetts General Hospital

Sponsor institution

Source ClinicalTrials.gov
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