Neoplasms

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Multiple Myeloma

Neoplasms, Plasma Cell

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Antineoplastic Agents

Antirheumatic Agents

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Cyclophosphamide

Fludarabine

Fludarabine phosphate

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Antineoplastic Agents, Alkylating

Alkylating Agents

Prior to receiving TriPRIL CAR T Cells, participants will undergo two preparatory processes:

* Leukapheresis: On day -8 white blood cells will be collected.
* Lymphodepletion: On days, -5, -4. -3 participants will receive 3 days of chemotherapy to decrease the number of lymphocytes

TriPRIL CAR T Cells will be administered intravenously on day 0 using a 3+3 dose escalation design

Prior to receiving TriPRIL CAR T Cells, participants will undergo two preparatory processes:

* Leukapheresis: On day -8 white blood cells will be collected.
* Lymphodepletion: On days, -5, -4. -3 participants will receive 3 days of chemotherapy to decrease the number of lymphocytes

TriPRIL CAR T Cells will be administered intravenously on day 0 using the respective dose (at or below the Maximum Tolerated Dose-MTD), as determined during the dose escalation part.

TriPRIL CAR T Cells

Matthew J Frigault, MD

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

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.

TriPRIL CAR T Cells in Multiple Myeloma

A Phase I Clinical Trial With TriPRIL CAR T Cells for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

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.

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

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

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

Sponsor Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
TriPRIL CAR T Cells in Multiple Myeloma	NCT05020444	Multiple Myelom... Multiple Myelom... Refractory Mult...	TriPRIL CAR T C... Cyclophosphamid... Fludarabine	18 Years -	Massachusetts General Hospital
TriPRIL CAR T Cells in Multiple Myeloma	NCT05020444	Multiple Myelom... Multiple Myelom... Refractory Mult...	TriPRIL CAR T C... Cyclophosphamid... Fludarabine	18 Years -	Massachusetts General Hospital

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