ClinicalTrials.gg
Not yet recruitingNCT07759102Updated Aug 12, 2026

Allogeneic ORCA-Q Stem Cell Transplant for the Treatment of Relapsed and Refractory High Risk Multiple Myeloma

A Phase 1 interventional study of Allogeneic Defined Hematopoietic Stem Cells/Immune Cells and Allogeneic Defined Hematopoietic Stem Cells/Immune Cells in Recurrent Multiple Myeloma and Refractory Multiple Myeloma, sponsored by University of California, Davis. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by University of California, Davis · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 2,167 studies in Multiple Myeloma with a site in United States — 276 open to participants now, 503 under way, 66 of them phase 3. Multiple Myeloma · United States.

Planned enrollment
1,309th of 1,900
20 · median 36
Started
2026
with 74 others
Phase 1
559 of 2,167
65 open now
Primary completion
2032-09
later than 466 of 498 live
Registered
2,160th of 2,167
by date

Among the 2,167 studies in Multiple Myeloma with a site in United States, this one is the 1,309th largest by planned enrollment of the 1,900 interventional ones, is one of 75 that started in 2026, is one of 559 in phase 1, reaches primary completion later than 466 of the 498 other live ones, and was the 2,160th registered.

By phase

2,167 studies; the count open now beside each. This study's row is marked.

Phase 2751 · 76 open
Phase 1this study559 · 65 open
Phase 1/2294 · 31 open
Phase 3184 · 28 open
No phase178 · 29 open
Observational167 · 41 open
Phase 414 · 4 open
Other kind13 · 1 open
Phase 2/37 · 1 open

By the year they started

First in 1975; this study’s year is marked. 75 started in 2026.

Size and results

Median enrollment 36 across the 1,900 interventional studies, 154 across the 167 observational. Of the 1,537 that completed or were terminated, 725 (47%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 2,167 studies in Multiple Myeloma with a site in United States, or all of them as a file.
02

Study summary

This phase I trial tests the effect of allogeneic Orca-Q stem cell transplant in treating patients with high-risk multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). An allogeneic (donor) transplant uses blood forming stem cells (graft) from a matched donor. When the healthy blood forming (stem) cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease [GVHD]). Orca-Q includes some T cells (a type a white blood cell) that are thought to help prevent some of the known complications as well as help attack the cancer cells. However, Orca-Q removes a specific type of T cell called naive T lymphocytes. Naive T cells may contribute to GVHD and are not thought to be required for the success of the treatment. Removing these cells may help reduce the frequency or severity of GVHD. Giving chemotherapy, such as thiotepa, busulfan, and fludarabine, before a donor stem cell transplant helps kill cancer cells in the body and prepare the body to receive the transplant graft. Giving allogeneic Orca-Q may be safe, tolerable, and/or effective in treating patients with relapsed or refractory (R/R) high-risk multiple myeloma.

Read the detailed description

PRIMARY OBJECTIVE:

I. To evaluate the safety of allogeneic ORCA-Q transplantation in subjects with R/R multiple myeloma with high-risk features.

SECONDARY OBJECTIVES:

I. To evaluate the efficacy of allogeneic ORCA-Q transplantation in subjects with R/R multiple myeloma with high-risk features.

II. To further evaluate the safety of allogeneic ORCA-Q transplantation in subjects with R/R multiple myeloma with high-risk features.

EXPLORATORY OBJECTIVE:

I. To further evaluate the efficacy of allogeneic ORCA-Q transplantation in subjects with R/R multiple myeloma with high-risk features.

OUTLINE:

DONORS: Donors receive granulocyte colony-stimulating factor (G-CSF) or filgrastim subcutaneously (SC) daily (QD) on days -6 to -3 and undergo apheresis on day -2 or -1. Donors may also undergo a second apheresis on day -1 or 0. Additionally, donors undergo blood sample collection at screening.

PATIENTS: Patients receive thiotepa intravenously (IV) over 3 hours on days -7 and -6, busulfan IV over 3 hours on days -5 to -3, fludarabine IV over 30 minutes on days -5 to -2, Orca-Q prime IV on day 0 followed by Orca-Q supplement IV on day 0 or 1 in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo echocardiography or multigated acquisition scan (MUGA) and optional positron emission tomography (PET)/computed tomography (CT) or CT at screening and urine and blood sample collection, as well as bone marrow aspiration and biopsy throughout the study.

After completion of study treatment, patients are followed up on days 1-7, 14, 21, 30, 60, 90, 180, and 365.

03

Conditions studied

  • Recurrent Multiple Myeloma
  • Refractory Multiple Myeloma

Browse trials for

Keywords

  • ORCA-Q
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ability to understand and sign
  • Age ≥ 18 years and ≤ 65 years
  • Patients should be in very good partial response (VGPR) (5% or less plasma cells in the marrow) or better response status at the time of stem cell transplant with no evidence of central nervous system (CNS) disease. Patients in complete response (CR) should have minimal residual disease (MRD) positivity
  • (ECOG) performance status of ≤ 1; or performance status (KPS) of ≥ 70%
  • ≥ 60 days from the last dose of an anti-CD38 antibody before the transplant
  • ≥ 6 months washout period from the last autologous transplant before the allogeneic transplant
  • Related or unrelated donors available as follows:

    • Sibling donor who is a 7/8 mismatched or 8/8 matched for human leukocyte antigen (HLA)-A, -B, -C, -DRB1
    • Matched unrelated donor who is a 7/8 mismatched or 8/8 matched for HLA-A, -B, -C, and -DRB1
  • A diagnosis of defined as:

    • Primary refractory disease or relapse \< 12 months following initial therapy that includes an immunomodulatory agent, proteasome inhibitor, anti-CD38 monoclonal antibody, and
    • Relapse \< 12 months after first autologous stem cell transplant
    • Failing to achieve complete response or relapsing after chimeric antigen receptor (CAR)-T treatment or bispecific antibodies; or indicated but ineligible for either bispecific antibodies or CAR-T cells due to low blood counts
    • No appropriate standard of care therapy per investigator
  • A diagnosis of ultra-high risk multiple myeloma defined as having at least one or more of these criteria:

    • Biallelic TP53 inactivation
    • ≥ 2 HRCAs: del(17p), TP53 mutation, t(4;14), t(14;16), t(14;20), gain(1q), amp(1q), del(1p32)
    • Biallelic del(1p32)
    • High-risk gene expression profile signature
    • Extramedullary disease excluding intramedullary plasmacytoma with extraosseous extension and active CNS disease
    • ≥ 2% circulating plasma cells
  • of ≥ 50 mL/min as estimated by Cockcroft-Gault
  • Total ≤ 1.5 times (ULN) except in subjects with Gilbert's syndrome in whom total bilirubin ≤ 3 times ULN
  • (ALT/serum glutamic pyruvic transaminase [SGPT]) and aspartate aminotransferase (AST/serum glutamic oxaloacetic transaminase [SGOT]) ≤ 3 x the upper limit of normal (ULN) or ≤ 5 x ULN if documented liver involvement by disease
  • Estimated (eGFR) > 50mL/minute. Creatinine clearance of ≥ 30 mL/min is allowed in patients eligible for no tacrolimus
  • Pulmonary function as defined by diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for ) ≥ 50%
  • Cardiac at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram, or radionuclide scan (multigated acquisition scan [MUGA])
  • Corrected diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%
  • Individuals of or those with partners of childbearing potential must agree to use methods of for the duration of study participation or be surgically sterilized
  • Stated ability and willingness to adhere to the study visit schedule and protocol requirements
  • DONOR: Ability to understand and sign informed consent
  • DONOR: Age ≥ 16 and ≤ 35 years at time of enrollment for unrelated donors and Age ≥ 16 and ≤ 50 years for related donors
  • DONOR: Either one of the following scenarios:

    • Sibling donor who is a 7/8 mismatched or 8/8 matched for HLA-A, -B, -C, and -DRB1, all typed using deoxyribonucleic acid (DNA)-based high-resolution methods
    • Unrelated donor who is 7/8 mismatched or 8/8 matched HLA-A, -B, -C, and -DRB1, all typed using DNA-based high-resolution methods
  • DONOR: Willing to donate stem cell mobilized mononuclear cells for up to two consecutive days
  • DONOR: Able to donate within the continental United States at a site that will employ a Spectra Optia Apheresis System for post-mobilization apheresis
  • DONOR: Meets federal eligibility criteria for donors of viable, leukocyte-rich cells or tissues and all relevant Food and Drug Administration (FDA) Guidance for Industry (Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, 2007; Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum [syphilis], 2015; Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products, 2016; Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products [HCT/Ps], 2016)
  • DONOR: Donors determined to be ineligible, based on the results of required testing and/or screening, may nonetheless be included if either applies:

    • The donor is a first-degree blood relative of the recipient
    • Urgent medical need, meaning no comparable human cell product is available, and the recipient is likely to suffer death or serious morbidity without the human cell product, as attested by the investigator
    • Meets any other criteria for donation as specified by standard National Marrow Donor Program (NMDP) guidelines (NMDP donors) or institutional standards (non-NMDP donors)

Exclusion criteria

Exclusion Criteria:

  • Prior hematopoietic cell transplantation (HCT)
  • Planned pharmaceutical in vivo or ex vivo T cell depletion, e.g., post-transplant cyclophosphamide (Cy), peri-transplant anti-thymocyte globulin (ATG), or alemtuzumab
  • Positive anti-donor HLA antibodies against a mismatched allele in the selected donor determined by either:

    • A positive crossmatch test of any titer; or
    • The presence of anti-donor HLA antibody to any HLA locus
  • Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) > 4
  • Uncontrolled bacterial, viral, or fungal infections (currently taking antimicrobial therapy and with no clinical improvement) at time of enrollment
  • Seropositive for -1 or -2, human T-cell lymphotropic virus (HTLV)-1 or -2
  • Documented allergy or documented to iron dextran or bovine, murine, algal or Streptomyces avidinii proteins
  • Concurrent or active disease within 1 year, except non-melanoma skin cancers or any carcinoma in situ that have been curatively resected
  • History of idiopathic or secondary myelofibrosis
  • Individuals who are pregnant or breastfeeding
  • Any condition that would prohibit the understanding or rendering of
  • Any condition that in the opinion of the investigator would interfere with the subject's safety or compliance while on study
  • A diagnosis of polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome
  • DONOR: Evidence of uncontrolled, active infection
  • DONOR: Seropositive for HIV-1 or -2, HTLV-1 or -2
  • DONOR: Positive for (HBV) surface antigen (HBsAg), total anti-hepatitis B core antibody (HBcAb, immunoglobulin [I]gG and IgM), HBV nucleic acid testing (NAT), anti- (HCV) antibody, or HCV NAT
  • DONOR: Aberrant 5RA isoform expression
  • DONOR: Women who are pregnant or breastfeeding
Terms in these criteria, in plain language(23)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

CD4 count

The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Treatment (Orca-Q, thiotepa, busulfan, fludarabine)

    Recipient participants receive thiotepa IV over 3 hours on days -7 and -6, busulfan IV over 3 hours on days -5 to -3, fludarabine IV over 30 minutes on days -5 to -2, Orca-Q prime IV on day 0, followed by Orca-Q supplement IV on day 0 or 1 in the absence of disease progression or unacceptable toxicity.

    Biological: Allogeneic Defined Hematopoietic Stem Cells/Immune Cells · Drug: Busulfan · Biological: Filgrastim · Drug: Fludarabine · Drug: Granulocyte Colony-Stimulating Factor · Drug: Thiotepa

Interventions

  • BiologicalAllogeneic Defined Hematopoietic Stem Cells/Immune Cells

    Drug page: Allogeneic Defined Hematopoietic Stem Cells/Immune Cells

    Given Orca-Q prime IV

    Also known as: Allogeneic Defined HSCs/Immune Cells, Allogeneic Defined Stem and Immune Cells, Orca-Q

  • BiologicalAllogeneic Defined Hematopoietic Stem Cells/Immune Cells

    Drug page: Allogeneic Defined Hematopoietic Stem Cells/Immune Cells

    Given Orca-Q supplement IV

    Also known as: Allogeneic Defined HSCs/Immune Cells, Allogeneic Defined Stem and Immune Cells, Orca-Q

  • Given IV

    Also known as: 1, 4-Bis[methanesulfonoxy]butane, BUS, Busilvex, Bussulfam, Busulfanum, Busulfex, Busulphan, CB 2041, CB-2041, Glyzophrol, GT 41, GT-41, Joacamine, Methanesulfonic Acid Tetramethylene Ester, Methanesulfonic acid, tetramethylene ester, Mielucin, Misulban, Misulfan, Mitosan, Myeleukon, Myeloleukon, Myelosan, Mylecytan, Myleran, Sulfabutin, Tetramethylene Bis(methanesulfonate), Tetramethylene bis[methanesulfonate], WR-19508

  • BiologicalFilgrastim

    Given SC

    Also known as: Filgrastim Biosimilar Filgrastim-sndz, Filgrastim Biosimilar Tbo-filgrastim, Filgrastim XM02, Filgrastim-aafi, Filgrastim-ayow, Filgrastim-sndz, G-CSF, Granix, Neupogen, Neutroval, Nivestim, Nivestym, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor, Releuko, rG-CSF, Tbo-filgrastim, Tevagrastim, XM02, Zarxio

  • Given IV

    Also known as: Fluradosa

  • Given SC

    Also known as: Colony Stimulating Factor 3, Colony-Stimulating Factor (Granulocyte), Colony-Stimulating Factor 3, CSF3, G CSF, G-CSF, GCSF, Granulocyte Colony Stimulating Factor, Pluripoietin

  • Given IV

    Also known as: 1,1',1''-Phosphinothioylidynetrisaziridine, Girostan, N,N', N''-Triethylenethiophosphoramide, Oncotiotepa, SH 105, SH-105, SH105, STEPA, Tepadina, Tepylute, TESPA, Tespamin, Tespamine, Thio-Tepa, Thiofosfamide, Thiofozil, Thiophosphamide, Thiophosphoamide, Thiophosphoramide, Thiotef, Tifosyl, TIO TEF, Tio-tef, Triethylene Thiophosphoramide, Triethylenethiophosphoramide, Tris(1-aziridinyl)phosphine sulfide, TSPA, WR 45312

06

What researchers measure

Primary outcomes

  1. Incidence of primary graft failure without grade II-IV acute graft-versus-host disease (GVHD)

    Frequency and proportions will be obtained.

    Time frame: From date of transplant and up to 30 days post-transplant

Secondary outcomes

  1. Overall survival

    The Kaplan-Meier (KM) method will be used to estimate the median and percentiles for time-to-event endpoints with 95% confidence intervals (CIs).

    Time frame: From transplant to death from any cause, assessed up to day 365 post-transplant

  2. Progression-free survival

    The KM method will be used to estimate the median and percentiles for time-to-event endpoints with 95% CIs.

    Time frame: From transplant to progressive disease or death, assessed up to 365 days post-transplant

  3. Time to relapse

    Time frame: From transplant to disease progression, initiation of new anti-multiple myeloma treatment, or death, whichever occurs first, assessed up to 365 days post-transplant

  4. Non-relapse mortality

    Will be analyzed using the cumulative incidence function to account for the competing risk of disease relapse/progression.

    Time frame: From transplant to death from any cause not including disease progression, assessed up to 365 days post-transplant

  5. Number of treatment-related adverse events (AEs)

    Will be classified by severity and graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0. Frequency and proportions will be obtained.

    Time frame: From date of enrollment up to 100 days post-transplant

  6. Occurrence of grade 3 or 4 treatment-emergent AEs

    Will be classified by severity and graded according to the NCI CTCAE v 6.0. Frequency and proportions will be obtained.

    Time frame: From date of transplant up to 100 days post-transplant

  7. Incidence of acute GVHD

    Time frame: From date of transplant up to 100 days post-transplant

  8. Incidence of chronic GVHD

    Time frame: From date of transplant up to 100 days post-transplant

  9. Incidence of GVHD free, relapse free survival

    The KM method will be used to estimate the median and percentiles for time-to-event endpoints with 95% CIs.

    Time frame: From date of transplant up to 365 days post-transplant

  10. Secondary graft failure rate

    Time frame: Up to day 365 post-transplant

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2032, 72 months later.

Of 201 non-industry phase 1 interventional studies under Multiple Myeloma, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 99. This study's planned 72 months is above that.

Counting every sponsor, half of 413 studies reached it within 50 months; a quarter within 33 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2026
First posted
Aug 12, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Sep 1, 2032
CompletionEst.
Sep 1, 2033
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07759102
Collaborators
National Cancer Institute (NCI), Orca Biosystems, Inc.
Responsible party
Sponsor
First posted
Aug 12, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2032 (estimated)
Completion
Sep 1, 2033 (estimated)
Last update
Aug 12, 2026

Study contacts

Office of Clinical Research
Contact
OCRReferral@health.ucdavis.edu
916-382-6970
Mehrdad Abedi
principal investigator · University of California, Davis

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Allogeneic Defined Hematopoietic Stem Cells/Immune Cells

Start the discussion