Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma

NCT03448978 | Terminated Phase 1 FDA Drug

• 1 other identifier: 241-59-88
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

This Phase I study will test the safety and anti-myeloma activity of ascending doses of Descartes-08 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.

Conditions

Multiple Myeloma

Keywords

Descartes-08; CAR T Cell; CART; CAR-T; CAR T-Cell; Multiple Myeloma; BCMA; B-cell maturation antigen; B cell maturation antigen

Outcome Measures

Primary Outcomes (1)

• Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Incidence (number) of Treatment-Emergent Adverse Events \[Safety and Tolerability\]. Descriptive statistics by incidence rate, body system classification, severity, and causality \[per protocol definitions\]

  2 weeks

Secondary Outcomes (1)

• Treatment response

  1, 3, 6, 9 and 12 months

Study Arms (1)

Descartes-08 plus fludarabine/cyclophosphamide pretreat

EXPERIMENTAL

Autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor

Biological: Descartes-08; Drug: Fludarabine; Drug: Cyclophosphamide

Interventions

Descartes-08 BIOLOGICAL

autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor

Also known as: CAR-T cells

Descartes-08 plus fludarabine/cyclophosphamide pretreat

Fludarabine DRUG

intravenous fludarabine

Descartes-08 plus fludarabine/cyclophosphamide pretreat

Cyclophosphamide DRUG

intravenous cyclophosphamide

Descartes-08 plus fludarabine/cyclophosphamide pretreat

Eligibility Criteria

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

You may qualify if:

• Multiple myeloma that is double-refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) after at least 2 prior lines of therapy OR have failed at least 3 prior lines of therapy
• Measurable disease activity as indicated by serum or urine M-protein, serum free light chain, biopsy-proven plasmacytoma, \>5% bone marrow plasma cells.
• Adequate vital organ function as indicated by ANC (\>1000/uL), platelet count (\>50,000/uL), hemoglobin (\>8 g/dL), serum ALT and AST (each \<3.0 x upper limit of normal), total bilirubin (\<2 mg/dL), creatinine clearance (\>30 mL/min), and cardiac ejection fraction (\>45%)

You may not qualify if:

• Active plasma cell leukemia
• Pregnant or lactating
• Active, uncontrolled infection
• Active and severe auto-immune disease
• Active arrhythmia, or obstructive or restrictive pulmonary disease
• Central nervous system disease

Sponsors & Collaborators

• Cartesian Therapeutics: lead

Study Sites (3)

The Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Virgina Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Immunotherapy, Adoptive; fludarabine; Cyclophosphamide

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

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Metin Kurtoglu, MD, PhD

  Cartesian Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: February 28, 2018
• Study Start: March 8, 2018
• Primary Completion: April 19, 2021
• Study Completion: June 3, 2021
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)