Multiple Myeloma in RelapsePhase 1NCT07611149

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

A Phase 1 study testing Administration of CAR T-cells at 3 different dose levels in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by Kure Cells, INC.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma in Relapse, Multiple Myeloma, Refractory
What is being tested?: Administration of CAR T-cells at 3 different dose levels
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: No sites listed yet
Study dates: 1 Sep 2026to 30 Dec 2028
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

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:

Show all 39Show fewer

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:
Hepatic:
o Total bilirubin ≤2× institutional upper limit of normal (ULN), except subjects with Gilbert's syndrome
AST and ALT ≤2.5× institutional ULN
Renal:
o Calculated creatinine clearance ≥30 mL/min (Cockcroft-Gault formula)
Cardiac:
o Left ventricular ejection fraction (LVEF) ≥45% by echocardiogram or MUGA
Pulmonary:
o ≤Grade 1 dyspnea
o Oxygen saturation ≥92% on room air
o If PFTs performed: FEV₁ ≥50% predicted and DLCO ≥40% predicted (corrected for hemoglobin)
Prior Therapy Washout:
o ≥2 weeks since last radiation or systemic anti-myeloma therapy (standard agents)
o ≥4 weeks since last investigational therapy
o ≥6 weeks since autologous stem cell transplant
Informed Consent: Ability to understand and willingness to provide written informed consent
Contraception Requirements (for subjects of reproductive potential):
Female subjects:
o Women of childbearing potential must: Have negative serum pregnancy test at screening Agree to use highly effective contraception (failure rate <1% per year) from enrollment through 6 months post-CAR-T infusion
Acceptable methods: bilateral tubal ligation, male partner sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing IUD, copper IUD
Sexual abstinence is acceptable if consistent with subject's preferred lifestyle
Male subjects:
Must agree to use condom plus effective contraception if partner is of childbearing potential
Must refrain from sperm donation from enrollment through 6 months post-CAR-T infusion

Who cannot join

Subjects meeting ANY of the following criteria will be excluded:
Disease-Specific Exclusions:
Active CNS involvement by multiple myeloma
Plasma cell leukemia
History of allogeneic hematopoietic stem cell transplantation
Malignancy Exclusions:

Show all 21Show fewer

o Second active malignancy, except: Non-melanoma skin cancer Carcinoma in situ (cervix, bladder, breast) Stage 1 uterine cancer Localized prostate cancer
Cardiovascular Exclusions:
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
Infectious Disease Exclusions:
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
Active infection requiring systemic therapy 5. Neurological Exclusions:
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
Examples: rheumatoid arthritis, lupus

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

DANIEL Couriel, MD, MS, MBA contact

7343539036

daniel@cellserveglobal.com

Ola Soliman, MD contact

6478650773

olaselkadi@gmail.com

About this study

Official title: A Phase 1, Single-Arm, Open-Label Study to Evaluate the Safety of UF-KURE-BCMA Cells in Patients With Relapsed or Refractory Multiple Myeloma

Read the detailed description

This is a Phase I, single-arm, open-label, dose-escalation study using a 3+3 design that evaluates the safety of UF (ultrafast)- KURE-BCMA for patients with relapsed/refractory multiple myeloma. Eligible patients are adults (≥18 years) with relapsed or refractory multiple myeloma after ≥3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. The study will accrue a total of 12 patients.

The primary objectives of this study are:

To determine the recommended Phase 2 dose (RP2D) of UF-KURE-BCMA
To establish the safety profile and identify dose-limiting toxicities (DLTs)

The secondary objectives:

Manufacturing feasibility
Overall response rate (ORR) per IMWG criteria
Duration of response (DOR)
Progression-free survival (PFS)
Overall survival (OS)

The exploratory objectives include:

CAR-T cell persistence and expansion
Replication-competent lentivirus (RCL) testing
Cytokine profiling
CAR-T cell phenotype characterization
Anti-BCMA CAR antibody development
Spatial multi-omics analysis of the bone marrow microenvironment

The study endpoints include:

Primary Endpoint Incidence of dose-limiting toxicities occurring within 28 days of CAR-T cell infusion Secondary Endpoints

Manufacturing success rate (≥75%)
Treatment-emergent adverse events
ORR, DOR, PFS, and OS per IMWG criteria

The Investigational Product is UF-KURE-BCMA, an autologous CAR-T cells manufactured using an ultra-fast process (approximately 17-20 hours), that targets specifically BCMA, a marker expressed on the surface of the myeloma cell. The study will evaluate 3 different dose levels:

Level -1: 3 × 10⁶ cells (≥50 kg) / 2 × 10⁶ cells (<50 kg)
Level 1 (Starting Dose): 10 × 10⁶ cells (≥50 kg) / 7 × 10⁶ cells (<50 kg)
Level 2: 15 × 10⁶ cells (≥50 kg) / 10 × 10⁶ cells (<50 kg) Prior to the cell infusion, the patients will receive a chemotherapy regimen (lymphodepleting regimen) that includes: Cyclophosphamide 300 mg/m² IV plus fludarabine 30 mg/m² IV, administered daily for 3 days (Days -4 to -2) The study will last 28 days, which is Dose-limiting toxicity (DLT) observation period. The follow-up period is 24 months with a long-term safety follow-up of 15 years.

The study endpoints:

Primary Endpoint Incidence of dose-limiting toxicities occurring within 28 days of CAR-T cell infusion Secondary Endpoints

Manufacturing success rate (≥75%)
Treatment-emergent adverse events
ORR, DOR, PFS, and OS per IMWG criteria

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

Conditions: Multiple Myeloma in Relapse, Multiple Myeloma, Refractory
Being tested: Administration of CAR T-cells at 3 different dose levels
Medical subject headings: Multiple Myeloma

What participants receive

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

Administration of CAR T-cells at 3 different dose levelsBiological
The patients will receive one of 3 dose levels as outlined above.

Study groups in NCT07611149
Study group	Role	What they receive
Lower Dose Level	Active comparator	Lower Dose (Level -1): 3 × 10⁶ cells (≥50 kg)// 2 × 10⁶ cells (<50 kg) Receives: 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) Receives: 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) Receives: Biological: Administration of CAR T-cells at 3 different dose levels

What is being measured

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

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

Secondary outcomes (6)

Manufacturing success rate
Manufacturing success rate is defined as manufacturing process leading to an adequate product per protocol standards. We expect this outcome to occur in ≥75% of the products manufactured.
Measured: 28 days post infusion
Treatment-emergent adverse events
Treatment adverse events related to the administration of CART-cells
Measured: At 24 months
ORR per IMWG criteria
Overall response rate
Measured: At 24 months
DOR
Duration of Response
Measured: At day 24 months
PFS
Progression-Free Survival
Measured: At 24 months
OS
Overall Survival
Measured: At 24 months

Timeline

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

1 Sep 202630 Dec 2028

First posted28 May 2026
Study start1 Sep 2026 (estimated)
Primary completion30 Sep 2028 (estimated)
Study completion30 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Multiple Myeloma in RelapseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Non-randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 12 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07611149
Sponsor's protocol ID: HEM02
Status last verified: May 2026
First submitted: 13 May 2026
Last updated: 28 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 33626253
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.
PubMed 10613347
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.
PubMed 37272512
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.
PubMed 32055000
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.
PubMed 35190680
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.
PubMed 36762851
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.
PubMed 30592986
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.
PubMed 27511158

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Single-Arm, Open-Label Study to Evaluate the Safety of UF-KURE-BCMA Cells in Patients With Relapsed or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT07611149
Acronym / sponsor ID: HEM02
Conditions: Multiple Myeloma in Relapse, Multiple Myeloma, Refractory
Phase: Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 12 participants (estimated)
Lead sponsor: Kure Cells, INCIndustry (pharma, biotech, devices)
Collaborators: CellServe LLC, Roya Clinical
Study start: 1 Sep 2026 (estimated)
Primary completion: 30 Sep 2028 (estimated)
Study completion: 30 Dec 2028 (estimated)
First posted: 28 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The primary objectives of this study are:

To determine the recommended Phase 2 dose (RP2D) of UF-KURE-BCMA
To establish the safety profile and identify dose-limiting toxicities (DLTs)

The secondary objectives:

Manufacturing feasibility
Overall response rate (ORR) per IMWG criteria
Duration of response (DOR)
Progression-free survival (PFS)
Overall survival (OS)

The exploratory objectives include:

CAR-T cell persistence and expansion
Replication-competent lentivirus (RCL) testing
Cytokine profiling
CAR-T cell phenotype characterization
Anti-BCMA CAR antibody development
Spatial multi-omics analysis of the bone marrow microenvironment

The study endpoints include:

Primary Endpoint Incidence of dose-limiting toxicities occurring within 28 days of CAR-T cell infusion Secondary Endpoints

Manufacturing success rate (≥75%)
Treatment-emergent adverse events
ORR, DOR, PFS, and OS per IMWG criteria

Level -1: 3 × 10⁶ cells (≥50 kg) / 2 × 10⁶ cells (<50 kg)
Level 1 (Starting Dose): 10 × 10⁶ cells (≥50 kg) / 7 × 10⁶ cells (<50 kg)
Level 2: 15 × 10⁶ cells (≥50 kg) / 10 × 10⁶ cells (<50 kg) Prior to the cell infusion, the patients will receive a chemotherapy regimen (lymphodepleting regimen) that includes: Cyclophosphamide 300 mg/m² IV plus fludarabine 30 mg/m² IV, administered daily for 3 days (Days -4 to -2) The study will last 28 days, which is Dose-limiting toxicity (DLT) observation period. The follow-up period is 24 months with a long-term safety follow-up of 15 years.

The study endpoints:

Primary Endpoint Incidence of dose-limiting toxicities occurring within 28 days of CAR-T cell infusion Secondary Endpoints

Manufacturing success rate (≥75%)
Treatment-emergent adverse events
ORR, DOR, PFS, and OS per IMWG criteria

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: 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.

Arm	Type	Receives
Lower Dose Level	Active comparator	Biological: Administration of CAR T-cells at 3 different dose levelsLower Dose (Level -1): 3 × 10⁶ cells (≥50 kg)// 2 × 10⁶ cells (<50 kg)
Starting Dose Level	Active comparator	Biological: Administration of CAR T-cells at 3 different dose levelsStarting Dose Level (Level 1) : 10 × 10⁶ cells (≥50 kg) / 7 × 10⁶ cells (<50 kg)
Higher Dose Level	Active comparator	Biological: Administration of CAR T-cells at 3 different dose levelsHigher Dose Level (Level 2): 15 × 10⁶ cells (≥50 kg) / 10 × 10⁶ cells (<50 kg)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (39 listed)

Age: ≥18 years at time of signing informed consent
Diagnosis: Documented multiple myeloma meeting one of the following:
Prior Therapy:
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):

Key exclusion criteria (21 listed)

Disease-Specific Exclusions:
Malignancy Exclusions:
o Second active malignancy, except: Non-melanoma skin cancer Carcinoma in situ (cervix, bladder, breast) Stage 1 uterine cancer Localized prostate cancer
Cardiovascular Exclusions:
Infectious Disease Exclusions:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Administration of CAR T-cells at 3 different dose levelsThe patients will receive one of 3 dose levels as outlined above.	Biological	Higher Dose Level, Lower Dose Level, Starting Dose Level

Primary outcome

Incidence of dose-limiting toxicities (DLT occurring within 28 days of CAR-T cell infusion)
Time frame: Within 28 days of CAR-T cell infusion
DLT

6 secondary outcomes

Manufacturing success rate
Time frame: 28 days post infusion
Treatment-emergent adverse events
Time frame: At 24 months
ORR per IMWG criteria
Time frame: At 24 months
DOR
Time frame: At day 24 months
PFS
Time frame: At 24 months
OS
Time frame: At 24 months

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
Background: PubMed 33626253Munshi 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.
Results publication: PubMed 10613347Hankey 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.
Results publication: PubMed 37272512San-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.
Results publication: PubMed 32055000Shah 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.
Results publication: PubMed 35190680Ghassemi 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.
Results publication: PubMed 36762851Rodriguez-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.
Results publication: PubMed 30592986Lee 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.
Results publication: PubMed 27511158Kumar 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.
U.S. Food and Drug Administration. Guidance for Industry: Long Term Follow-up After Administration of Human Gene Therapy Products. January 2020.Link provided by the sponsor.
International Council for Harmonisation. ICH E6(R2) Good Clinical Practice. November 2016.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

DANIEL Couriel, MD, MS, MBA contact

7343539036

daniel@cellserveglobal.com

Ola Soliman, MD contact

6478650773

olaselkadi@gmail.com

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Administration of CAR T-cells at 3 different dose levels in people with Multiple Myeloma in Relapse and Multiple Myeloma, Refractory, run by Kure Cells, INC.

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 39 inclusion and 21 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: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact DANIEL Couriel, MD, MS, MBA (7343539036, daniel@cellserveglobal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicities (DLT occurring within 28 days of CAR-T cell infusion) (time frame: Within 28 days of CAR-T cell infusion). 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 NCT07611149, which also lists 8 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 28 May 2026.