CART-BCMA Cells for Multiple Myeloma

Phase 1

Completed

• Conditions: Multiple Myeloma
• Interventions: Biological: CART-BCMA

• Registration Number: NCT02546167
• Lead Sponsor: University of Pennsylvania

Brief Summary

Open-label, single-center, pilot study to assess the safety and feasibility of infusion of autologous T cells expressing BCMA (B-cell maturation antigen)-specific chimeric antigen receptors with tandem TCR and 4-1BB costimulatory domains (referred to as CART-BCMA ) in adult patients with multiple myeloma (MM). CART-BCMA cells will be given as a split dose intravenous infusion over 3 days. The duration of active intervention and monitoring is approximately 2 years.

Detailed Description

At entry subjects will undergo routine laboratory and imaging assessment of their multiple myeloma. Eligible subjects will undergo steady-state apheresis to obtain large numbers of peripheral blood mononuclear cells (PBMC) for CART-BCMA manufacturing. Cryopreserved historical apheresis products collected from the patient prior to study entry are usable for CART-BCMA manufacturing if collected at an appropriately certified apheresis center and the product meets adequate mononuclear cell yields. If a historical apheresis product is not available, an apheresis procedure will be scheduled for cell procurement after study entry. The T cells will be purified from the PBMC, transduced with TCRζ/4-1BB lentiviral vector, expanded in vitro and then frozen for future administration. The number of subjects who have inadequate T cell collections, expansion or manufacturing compared to the number of subjects who have CAR T cells successfully manufactured will be recorded; feasibility of product manufacturing is not expected to be problematic in this patient population.

Study Timeline

• Study Start: 2015-09-03
• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-10
• Primary Completion: 2019-08-21
• Study Completion: 2020-07-27
• Status Verified: 2020-08
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	CART-BCMA	will receive 1-5x10\^7 CART-BCMA cells given as a split dose infusion over 3 days.
Cohort 3	CART-BCMA	Cyclophosphamide infusion prior to 1-5x10\^8 CART BCMA cells given as a split dose infusion over 3 days.
Cohort 2	CART-BCMA	Cyclophosphamide infusion prior to 1-5x10\^7 CART BCMA cells given as a split dose infusion over 3 days.

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	2 years	Study related adverse events (defined as ≥ Grade 3 signs/symptoms according to CTCAE 4.03, laboratory toxicities, and clinical events) that are "possibly", "probably", or "definitely" related to study treatment any time from the first day of study treatment until end of study visit.

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States