A New Study Evaluating the Activity of Modular CAR T for mYeloma

NCT04795882 | Recruiting Phase 1 DMC

• 1 other identifier: UCL 129642
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1 rolling 6 trial design evaluating safety of a novel BCMA Chimeric Antigen Receptor (CAR) alone and of CAR T cells engineered to co-express BCMA CAR and a CD19 CAR in patients with relapsed / refractory Multiple Myeloma. The study will assess the feasibility of generating these Advanced Therapy Investigational Products (ATIMPs) and the safety of administering the CAR T cells (either BCMA alone or co-expressed with CD19) in patients with relapsed / refractory multiple myeloma.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Toxicity evaluated by the incidence of grade 3-5 toxicity causally related to the Advanced Therapy Investigational Product (ATIMP)

  The incidence of grade 3-5 toxicity assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and the American Society for Transplantation and Cellular Therapy (ASTCT) Cytokine Release Syndrome (CRS) and Neurotoxicity tool

  28 days

• Feasibility of manufacturing CAR T-cells evaluated by the number of therapeutic products generated

  Feasibility of generation of CAR T cells as evaluated by the number of therapeutic products generated.

  30 days

Study Arms (2)

Cohort 1: BCMA CAR T cells

EXPERIMENTAL

Treatment with Advanced Therapy Investigational Product (ATIMP): BCMA CAR T-cells

Biological: BCMA CAR T cells

Cohort 2: BCMA/CD19 CAR T cells

EXPERIMENTAL

Treatment with Advanced Therapy Investigational Product (ATIMP): BCMA/CD19 CAR T-cells

Biological: BCMA/CD19 CAR T cells

Interventions

BCMA CAR T cells BIOLOGICAL

Infusion with ATIMP: BCMA CAR T-cells

Cohort 1: BCMA CAR T cells

BCMA/CD19 CAR T cells BIOLOGICAL

Infusion with ATIMP: BCMA/CD19 CAR T-cells

Cohort 2: BCMA/CD19 CAR T cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Relapsed/Refractory Multiple Myeloma
• Secretory disease: PP≥5g/L and/or sFLC≥100mg/L of involved light chain with abnormal K:L ratio.
• ≥3 prior lines of therapies (including proteasome inhibitor, IMiD, anti CD38 antibody)
• Refractory to last line of therapy (not achieved at least PR and progressed within 60 days of last dose or achieved at least PR but progressed within 6 months of last dose)
• Has previously received or is not suitable for ASCT
• Eastern Cooperative Oncology Group (ECOG) performance status 0/1
• Creatinine Clearance (CrCl)≥40ml/min, Absolute Neutrophil Count (ANC)≥1x10\^9/L, Platelets (plt)≥50x10\^9/L, Haemoglobin (Hb)≥80 /L, lymphocyte count ≥0.3x10\^9/L
• Patients must weigh \>30 kg
• Agreement to have a pregnancy test, use adequate contraception (if applicable)
• Written informed consent

You may not qualify if:

• Previous diagnosis of systemic light chain amyloidosis
• Prior treatment with investigational or approved gene therapy or cell therapy products
• Stem cell transplant patients only:
• allogeneic stem cell transplant within 12 months prior to registration into the study
• moderate/ severe chronic GVHD (NIH consensus criteria) requiring immunosuppressive therapy and/or systemic steroids
• Oxygen saturation ≤ 90% on air
• Patients with clinically significant, uncontrolled heart disease or a recent (within 6 months) cardiac event
• Left ventricular ejection fraction \< 50% (ECHO or MUGA)
• Corrected QT interval (QTc)\>470 ms on ECG
• Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded)
• History or evidence of deep vein thrombosis or pulmonary embolism requiring ongoing therapeutic anticoagulation at preconditioning
• Chronic renal impairment requiring dialysis
• Patients with significant liver disease: alanine aminotransferase or aspartate aminotransferase ≥3x upper limit normal (ULN), or total bilirubin ≥25umol/L (1.5mg/dL), except in patients with Gilbert's syndrome, or evidence of end-stage liver disease (e.g. ascites, hepatic encephalopathy)
• Patients with any major surgical intervention in the last 3 months, cement augmentation for vertebral collapse is permitted
• Patients with active gastrointestinal bleeding

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospital

London, County (Optional), United Kingdom

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

MCARTY Trial Coordinator

CONTACT

02076799599; ctc.MCARTY@ucl.ac.uk

Lydia Lee

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Rolling 6 trial design

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 12, 2021
• Study Start: April 22, 2022
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)