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Relapsed and Refractory Multiple MyelomaPhase 1NCT04155749

Study of Anitocabtagene-autoleucel in Participants With Relapsed Refractory Multiple Myeloma

A Phase 1 study testing anitocabtagene-autoleucel in people with Relapsed and Refractory Multiple Myeloma, run by Kite, A Gilead Company at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed and Refractory Multiple Myeloma
What is being tested?
anitocabtagene-autoleucel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
4 sitesUnited States
Study dates
23 Dec 2019to May 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Advanced Cellular Therapeutics Facility, DCAM 0800A

    Chicago, Illinois, 60637

  • Froedtert Hospital/Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Official title: Master Protocol for the Phase 1 Study of Cell Therapies for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, Including Long-term Safety Follow-up

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

Being tested
anitocabtagene-autoleucel
Keywords
BCMA, Myeloma, Chimeric
Medical subject headings
Recurrence, Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anitocabtagene-autoleucelDrug

    Chimeric Antigen Receptor T cells

Study groups in NCT04155749
Study groupRoleWhat they receive
ARM 1ExperimentalPhase 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
Receives: Drug: anitocabtagene-autoleucel

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 24 months

  2. Establish the RP2D of the investigational agent

    Measured: 24 months

Secondary outcomes (5)

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

    Measured: 24 months

  2. Overall Response Rate (ORR) by IMWG Consensus Criteria

    Measured: 24 months

  3. PK Parameter for Anitocabtagene-Autoleucel: Cmax

    Cmax is defined as the maximum observed concentration of drug.

    Measured: Day 1 up to 24 months

  4. PK Parameter for Anitocabtagene-autoleucel: Tmax

    Tmax is defined as the time (observed time point) of Cmax.

    Measured: Day 1 up to 24 months

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

    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

    Measured: Day 1 up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2019
  2. Study start23 Dec 2019
  3. Primary completion3 Oct 2024
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04155749
Sponsor's protocol ID
ARC-101-ARM1
Status last verified
Feb 2026
First submitted
17 Oct 2019
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Frigault MJ, Dhakal B, Jakubowiak AJ, Raje N, Banerjee K, Mu CJ, Hart KC, Shachar S, Andrews LP, Cheung LS, Griffin FM, Witter AR, Hyde M, Pham C, Gandra N, Shakya T, Rajan B, Cortesio C, Haile ST, Nowyhed H, Nair-Gupta P, Mitra P, Chan RJ, Kostic A, Heery CR, Rosenblatt J, Bishop MR. Phase 1 Study of Anito-cel, a d-Domain BCMA CAR T Cell for Refractory or Recurrent Myeloma. N Engl J Med. 2026 Sep 24;395(12):1180-1192. doi: 10.1056/NEJMoa2603527.

    PubMed 42777241

  • 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.

    PubMed 35737298

  • 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.

    PubMed 35468618

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing anitocabtagene-autoleucel in people with Relapsed and Refractory Multiple Myeloma, run by Kite, A Gilead Company at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (TEAEs), including DLT(s) (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04155749, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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