Study to Evaluate the Safety of UF-KURE-BCMA CAR T-Cells in Advanced Myeloma

NCT07611149 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HEM02
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to evaluate the safety of a new type of CAR T-cell, UF-KURE-BCMA, for the treatment of patients with advanced multiple myeloma that has not responded to other therapies. The main question is whether the use of these new CAR T-cells is safe for patients with this condition. Secondarily, the study will also look at the response of myeloma to this therapy.

Conditions

Multiple Myeloma, Refractory; Multiple Myeloma in Relapse

Outcome Measures

Primary Outcomes (1)

• Incidence of dose-limiting toxicities (DLT occurring within 28 days of CAR-T cell infusion)

  DLT

  Within 28 days of CAR-T cell infusion

Secondary Outcomes (6)

• Manufacturing success rate

  28 days post infusion

• Treatment-emergent adverse events

  At 24 months

• ORR per IMWG criteria

  At 24 months

• DOR

  At day 24 months

• PFS

  At 24 months

Study Arms (3)

Lower Dose Level

ACTIVE COMPARATOR

Lower Dose (Level -1): 3 × 10⁶ cells (≥50 kg)// 2 × 10⁶ cells (\<50 kg)

Biological: Administration of CAR T-cells at 3 different dose levels

Starting Dose Level

ACTIVE COMPARATOR

Starting Dose Level (Level 1) : 10 × 10⁶ cells (≥50 kg) / 7 × 10⁶ cells (\<50 kg)

Biological: Administration of CAR T-cells at 3 different dose levels

Higher Dose Level

ACTIVE COMPARATOR

Higher Dose Level (Level 2): 15 × 10⁶ cells (≥50 kg) / 10 × 10⁶ cells (\<50 kg)

Biological: Administration of CAR T-cells at 3 different dose levels

Interventions

Administration of CAR T-cells at 3 different dose levels BIOLOGICAL

The patients will receive one of 3 dose levels as outlined above.

Higher Dose Level; Lower Dose Level; Starting Dose Level

Eligibility Criteria

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

You may qualify if:

• Subjects must meet ALL of the following criteria to be eligible for study enrollment:
• Age: ≥18 years at time of signing informed consent
• Diagnosis: Documented multiple myeloma meeting one of the following:
• Relapsed disease: Progression after achieving at least minimal response (MR) to prior therapy
• Refractory disease: Non-responsive or progressive disease while on therapy or within 60 days of last treatment (in subjects who achieved ≥MR on prior therapy)
• Prior Therapy:
• Received ≥3 prior lines of anti-myeloma therapy
• Prior therapy must include:
• At least one proteasome inhibitor At least one immunomodulatory drug (e.g., lenalidomide, pomalidomide, thalidomide) At least one anti-CD38 monoclonal antibody (e.g., daratumumab, isatuximab) o Prior anti-BCMA CAR-T therapy is permitted if subject achieved PFS ≥6 months post-infusion
• Measurable Disease: At least one of the following at screening (for response assessment eligibility):
• Serum M-protein ≥0.5 g/dL by protein electrophoresis (SPEP)
• Urine M-protein ≥200 mg/24 hours by protein electrophoresis (UPEP)
• Serum free light chain (FLC) difference ≥10 mg/dL with abnormal FLC ratio Note: Subjects with non-measurable disease may enroll for safety assessment
• Performance Status: ECOG Performance Status 0-2 (see Appendix A)
• Organ Function: Adequate organ function as defined by:

You may not qualify if:

• Subjects meeting ANY of the following criteria will be excluded:
• Active CNS involvement by multiple myeloma
• Plasma cell leukemia
• History of allogeneic hematopoietic stem cell transplantation
• o Second active malignancy, except: Non-melanoma skin cancer Carcinoma in situ (cervix, bladder, breast) Stage 1 uterine cancer Localized prostate cancer
• New York Heart Association (NYHA) Class IV congestive heart failure
• Unstable angina pectoris
• Clinically significant cardiac arrhythmias
• Myocardial infarction, stroke, or TIA within 6 months of enrollment
• Known HIV infection or AIDS-related illness
• Active hepatitis B or C infection:
• Positive HBsAg, or Positive anti-HBc or anti-HCV with detectable viral nucleic acid by PCR
• History of clinically relevant CNS pathology including:
• Epilepsy or seizure disorders Paresis, aphasia Uncontrolled cerebrovascular disease Severe brain injury Dementia Parkinson's disease 6. Autoimmune Disease:
• Active autoimmune disease requiring systemic immunosuppression \>15 mg/day prednisone equivalent within past 6 months

Sponsors & Collaborators

• Kure Cells, INC: lead
• CellServe LLC: collaborator
• Roya Clinical: collaborator

Related Publications (8)

• Munshi NC, Anderson LD Jr, Shah N, Madduri D, Berdeja J, Lonial S, Raje N, Lin Y, Siegel D, Oriol A, Moreau P, Yakoub-Agha I, Delforge M, Cavo M, Einsele H, Goldschmidt H, Weisel K, Rambaldi A, Reece D, Petrocca F, Massaro M, Connarn JN, Kaiser S, Patel P, Huang L, Campbell TB, Hege K, San-Miguel J. Idecabtagene Vicleucel in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2021 Feb 25;384(8):705-716. doi: 10.1056/NEJMoa2024850.

  PMID: 33626253 BACKGROUND

• Hankey BF, Ries LA, Edwards BK. The surveillance, epidemiology, and end results program: a national resource. Cancer Epidemiol Biomarkers Prev. 1999 Dec;8(12):1117-21. No abstract available.

  PMID: 10613347 RESULT

• San-Miguel J, Dhakal B, Yong K, Spencer A, Anguille S, Mateos MV, Fernandez de Larrea C, Martinez-Lopez J, Moreau P, Touzeau C, Leleu X, Avivi I, Cavo M, Ishida T, Kim SJ, Roeloffzen W, van de Donk NWCJ, Dytfeld D, Sidana S, Costa LJ, Oriol A, Popat R, Khan AM, Cohen YC, Ho PJ, Griffin J, Lendvai N, Lonardi C, Slaughter A, Schecter JM, Jackson CC, Connors K, Li K, Zudaire E, Chen D, Gilbert J, Yeh TM, Nagle S, Florendo E, Pacaud L, Patel N, Harrison SJ, Einsele H. Cilta-cel or Standard Care in Lenalidomide-Refractory Multiple Myeloma. N Engl J Med. 2023 Jul 27;389(4):335-347. doi: 10.1056/NEJMoa2303379. Epub 2023 Jun 5.

  PMID: 37272512 RESULT

• Shah N, Chari A, Scott E, Mezzi K, Usmani SZ. B-cell maturation antigen (BCMA) in multiple myeloma: rationale for targeting and current therapeutic approaches. Leukemia. 2020 Apr;34(4):985-1005. doi: 10.1038/s41375-020-0734-z. Epub 2020 Feb 13.

  PMID: 32055000 RESULT

• Ghassemi S, Durgin JS, Nunez-Cruz S, Patel J, Leferovich J, Pinzone M, Shen F, Cummins KD, Plesa G, Cantu VA, Reddy S, Bushman FD, Gill SI, O'Doherty U, O'Connor RS, Milone MC. Rapid manufacturing of non-activated potent CAR T cells. Nat Biomed Eng. 2022 Feb;6(2):118-128. doi: 10.1038/s41551-021-00842-6. Epub 2022 Feb 21.

  PMID: 35190680 RESULT

• Rodriguez-Otero P, Ailawadhi S, Arnulf B, Patel K, Cavo M, Nooka AK, Manier S, Callander N, Costa LJ, Vij R, Bahlis NJ, Moreau P, Solomon SR, Delforge M, Berdeja J, Truppel-Hartmann A, Yang Z, Favre-Kontula L, Wu F, Piasecki J, Cook M, Giralt S. Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma. N Engl J Med. 2023 Mar 16;388(11):1002-1014. doi: 10.1056/NEJMoa2213614. Epub 2023 Feb 10.

  PMID: 36762851 RESULT

• Lee DW, Santomasso BD, Locke FL, Ghobadi A, Turtle CJ, Brudno JN, Maus MV, Park JH, Mead E, Pavletic S, Go WY, Eldjerou L, Gardner RA, Frey N, Curran KJ, Peggs K, Pasquini M, DiPersio JF, van den Brink MRM, Komanduri KV, Grupp SA, Neelapu SS. ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Biol Blood Marrow Transplant. 2019 Apr;25(4):625-638. doi: 10.1016/j.bbmt.2018.12.758. Epub 2018 Dec 25.

  PMID: 30592986 RESULT

• Kumar S, Paiva B, Anderson KC, Durie B, Landgren O, Moreau P, Munshi N, Lonial S, Blade J, Mateos MV, Dimopoulos M, Kastritis E, Boccadoro M, Orlowski R, Goldschmidt H, Spencer A, Hou J, Chng WJ, Usmani SZ, Zamagni E, Shimizu K, Jagannath S, Johnsen HE, Terpos E, Reiman A, Kyle RA, Sonneveld P, Richardson PG, McCarthy P, Ludwig H, Chen W, Cavo M, Harousseau JL, Lentzsch S, Hillengass J, Palumbo A, Orfao A, Rajkumar SV, Miguel JS, Avet-Loiseau H. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol. 2016 Aug;17(8):e328-e346. doi: 10.1016/S1470-2045(16)30206-6.

  PMID: 27511158 RESULT

Related Links

• U.S. Food and Drug Administration. Guidance for Industry: Long Term Follow-up After Administration of Human Gene Therapy Products. January 2020.
• International Council for Harmonisation. ICH E6(R2) Good Clinical Practice. November 2016.

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

DANIEL Couriel, MD, MS, MBA

CONTACT

7343539036; daniel@cellserveglobal.com

Ola Soliman, MD

CONTACT

6478650773; olaselkadi@gmail.com

Study Design

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

Model Details: A standard 3+3 dose-escalation design will be used to evaluate 3 dose levels. Safety and efficacy will be summarized using descriptive statistics. Time-to-event endpoints will be analyzed using the Kaplan-Meier method.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: May 28, 2026

Record last verified: 2026-05