NCT04155749

Brief Summary

Master protocol for cell therapy, Phase 1 proof-of-concept studies in relapsed and refractory multiple myeloma and includes long-term safety follow-up.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
12mo left

Started Dec 2019

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Dec 2019May 2027

First Submitted

Initial submission to the registry

October 17, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 23, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2024

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Expected
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

4.8 years

First QC Date

October 17, 2019

Last Update Submit

February 9, 2026

Conditions

Relapsed and Refractory Multiple Myeloma

Keywords

BCMAMyelomaChimeric

Outcome Measures

Primary Outcomes (2)

  • Incidence of treatment-emergent adverse events (TEAEs), including DLT(s)

    24 months

  • Establish the RP2D of the investigational agent

    24 months

Secondary Outcomes (5)

  • Best overall response (BOR) by International Myeloma Working Group (IMWG) Consensus Criteria

    24 months

  • Overall Response Rate (ORR) by IMWG Consensus Criteria

    24 months

  • PK Parameter for Anitocabtagene-Autoleucel: Cmax

    Day 1 up to 24 months

  • PK Parameter for Anitocabtagene-autoleucel: Tmax

    Day 1 up to 24 months

  • PK Parameter for Anitocabtagene-Autoleucel: Area under the curve (AUC)

    Day 1 up to 24 months

Study Arms (1)

ARM 1

EXPERIMENTAL

Phase I study of BCMA-specific CAR-modified T-cell therapy using alternative binding domain, for the treatment of patients with relapsed and refractory multiple myeloma

Drug: anitocabtagene-autoleucel

Interventions

anitocabtagene-autoleucelDRUG

Chimeric Antigen Receptor T cells

ARM 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Relapsed and refractory Multiple Myeloma treated with at least 3 prior regimens of system therapy including Proteosome Inhibitor (PI), immunomodulatory drugs (IMiD), and anti-CD38 antibody (CD38mab); or has "triple-refractory" disease
  • Documented measurable disease
  • Adequate organ function
  • Life expectancy \> 12 weeks, Eastern Cooperative Group Performance Status 0-1

You may not qualify if:

  • Plasma Cell Leukemia or History of Plasma Cell Leukemia
  • Patients with a history of severe hypersensitivity to DMSO should be excluded
  • Contraindication to fludarabine or cyclophosphamide
  • Severe uncontrolled intercurrent illness (e.g., infection) or laboratory abnormalities
  • Active central nervous system disease involvement by malignancy or active CNS pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Advanced Cellular Therapeutics Facility, DCAM 0800A

Chicago, Illinois, 60637, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Froedtert Hospital/Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

  • Buonato JM, Edwards JP, Zaritskaya L, Witter AR, Gupta A, LaFleur DW, Tice DA, Richman LK, Hilbert DM. Preclinical Efficacy of BCMA-Directed CAR T Cells Incorporating a Novel D Domain Antigen Recognition Domain. Mol Cancer Ther. 2022 Jul 5;21(7):1171-1183. doi: 10.1158/1535-7163.MCT-21-0552.

    PMID: 35737298DERIVED

  • Frigault MJ, Bishop MR, Rosenblatt J, O'Donnell EK, Raje N, Cook D, Yee AJ, Logan E, Avigan DE, Jakubowiak A, Shaw K, Daley H, Nikiforow S, Griffin F, Cornwell C, Shen A, Heery C, Maus MV. Phase 1 study of CART-ddBCMA for the treatment of subjects with relapsed and refractory multiple myeloma. Blood Adv. 2023 Mar 14;7(5):768-777. doi: 10.1182/bloodadvances.2022007210.

    PMID: 35468618DERIVED

Related Links

MeSH Terms

Conditions

RecurrenceMultiple MyelomaNeoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Arcellx, Inc.

    Arcellx, Inc.

    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

October 17, 2019

First Posted

November 7, 2019

Study Start

December 23, 2019

Primary Completion

October 3, 2024

Study Completion (Estimated)

May 1, 2027

Last Updated

February 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(4)