ClinicalTrials.gg
RecruitingNCT07336472Updated Sep 25, 2026

A Study of IBI3003 in Subjects With Relapsed or Refractory Multiple Myeloma

A Phase 1/2 interventional study of IBI3003 in Multiple Myeloma, sponsored by Fortvita Biologics (USA)Inc.. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Fortvita Biologics (USA)Inc. (part of Innovent Biologics, Inc.) · Phase 1/2, Interventional, and Treatment

Updated Sep 25, 2026Now RecruitingFirst site in United States+4 moreGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
360
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This is a phase 1/2 multicenter, open-label, first-in-human study of IBI3003. It includes a phase 1 dose escalation and expansion section to identify maximum tolerated dose(MTD)/recommended Phase 2 Dose(RP2D) of IBI3003, plans to enroll 54\~360 subjects, and a phase 2 stage to explore efficacy, safety and tolerability of IBI3003 at RP2D in multiple myeloma

02

Conditions studied

  • Multiple Myeloma

Browse trials for

03

In context

Multiple Myeloma

3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.

This study's planned enrollment of 360 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Fortvita Biologics (USA)Inc. is the lead sponsor of 5 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Participants in Parts 1 \& 2 must satisfy all of the following criteria to be enrolled in the study:

  1. Age ≥18 years.
  2. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria.

    Multiple myeloma is defined as clonal bone marrow plasma cells ≥10% or -proven bony or extramedullary plasmacytoma, and any one or more of the following myelomadefining events:

    • Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: Hypercalcemia: serum calcium >0.25 mmol/L (>1 mg/dL) higher than the or corrected serum calcium >2.75 mmol/L (>11 mg/dL) Renal insufficiency: \<40 mL/min or serum creatinine >177 μmol/L (>2 mg/dL) Anemia: value of >2 g/dL below the lower limit of normal, or a hemoglobin value \<10 g/dL Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT
    • Any one or more of the following biomarkers of :

    Clonal bone marrow plasma cell percentage ≥60% Involved: uninvolved serum free light chain ratio ≥100 (involved FLC level must be

    ≥100 mg/L) >1 focal lesions on MRI studies (at least 5 mm in size)

  3. measurable multiple myeloma (R/R MM) following prior treatment with ≥3 lines of systemic anti-myeloma therapy that include at least a proteasome inhibitor (PI), an immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy, and with limited or no therapeutic options that are likely to offer a favorable risk/benefit profile; participants must be relapsed or refractory to their last anti-myeloma regimen.
  4. (ECOG) Performance Status score of 0 or 1
  5. At least one of the following indicators:

    • Serum M-protein ≥5 g/L (for IgA and IgD subtypes, quantitative immunoglobin measurements could be used as substitutions for M-protein)
    • Urine M-protein ≥200 mg/24h
    • Serum free light chain (FLC) test: affected FLC level ≥100 mg/L and abnormal serum FLC ratio (\<0.26 or >1.65)
  6. Adequate hematologic, hepatic, renal and cardiac function:

    • Blood count: ≥1.0×10\^9/L, hemoglobin ≥70 g/L, and count ≥50×10\^9/L (values must be achieved without growth factors or blood transfusions within 7 days prior to first dose)
    • Hepatic function: (AST) and alanine aminotransferase (ALT) both ≤2.5× upper limit of normal (ULN) and total (TBIL) ≤1.5×ULN
    • Renal function: calculated creatinine ≥30 mL/min by the Cockcroft-Gault Equation
    • Cardiac function: (LVEF) ≥50%
  7. ≥3 months.
  8. Women of and fertile men who are sexually active must agree to use a highly effective method of (\<1% / year failure rate) during the study and for 90 days after the last dose level of study drug. Contraception must be consistent with local regulations or standards regarding the use of birth control methods by participants participating in clinical trials. Women and men must agree not to donate or bank eggs (ova, oocytes) or sperm, respectively, during the study and for 90 days after the last dose level of study drug.
  9. Participants with the ability to understand and give written for participation in this trial, including all evaluations and procedures as specified by this protocol.
  10. Willing and able to adhere to the complete schedule of assessments and all prohibitions and restrictions specified in this protocol

Exclusion criteria

Exclusion Criteria

Participants who meet any of the following criteria will be disqualified from entering the study:

  1. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
  2. Active amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, or solitary plasmacytoma, or smoldering multiple myeloma (MM) as defined by the IMWG criteria.
  3. Spinal cord compression that results in limited self-care at present or within 6 months prior to , or that is expected to cause such limitations during Study participation.
  4. History of primary immunodeficiency.
  5. Current or previous other within 3 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy.
  6. hematopoietic stem cell transplantation within the last 6 months, or autologous stem cell transplantation within the last 3 months prior to the first administration of the study drug.
  7. History of organ transplantation.
  8. Active .
  9. Thromboembolism or cerebrovascular events (e.g., myocardial infarction, unstable angina, , cerebrovascular accident, deep vein thrombosis [unless associated with complications of central venous access], or pulmonary embolism) within 6 months prior to the first dose of study drug.
  10. Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation.
  11. Known allergies, , or intolerance to IBI3003 or its (refer to Investigator's Brochure).
  12. Prior toxicities that have not resolved to ≤Grade 1 prior to study treatment administration except for stable chronic toxicities (≤Grade 2) not expected to resolve (e.g., stable Grade 2 peripheral neurotoxicity)
  13. Prior antitumor therapy as follows, prior to the first dose of study drug:

    • Gene modified adoptive cell therapy (e.g., chimeric antigen receptor modified T cells, natural killer cells) within 8 weeks.
    • Targeted therapy, epigenetic therapy, or treatment with an drug or an invasive investigational medical device within 14 days or at least 5 half-lives, whichever is longer.
    • Antibody treatment (e.g., monoclonal antibody, bispecific antibody) for multiple myeloma within 21 days.
    • Cytotoxic therapy (including antibody-drug conjugates) within 14 days.
    • Proteasome inhibitor therapy within 14 days Immunomodulatory agent therapy within 7 days.
    • Radiotherapy within 21 days. However, if the radiation field covered ≤5% of the bone marrow reserve, the participant is eligible irrespective of the end date of radiotherapy.
    • Cancer vaccine received within 3 months.
  14. Use of therapy within 28 days of the start date of study treatment.

    Immunosuppressive therapy includes, but is not limited to, cyclosporine A, tacrolimus, and mycophenolate mofetil, but does not include given as part of an antimyeloma regimen. Participants receiving corticosteroids must be at a dose level ≤10 mg/day of prednisone equivalent for at least 7 days prior to the start of study treatment administration.

  15. Live or administered within 4 weeks prior to start of study treatment, or anticipated need for live or live attenuated vaccine during the study.
  16. Uncontrolled diseases, including:

    • Uncontrolled infection or infection requiring systemic antibiotics, antivirals or antifungals within one week prior to first administration of the study drug;
    • Known (HIV) infection, or HIV positive (HIV 1/2 Ab positive);
    • For participants in mainland China, acute or chronic active (HBsAg positive and/or HBcAb positive with HBV DNA titer ≥104 copies/mL or ≥2000 IU/mL) or C ( Ab positive with HCV RNA>103 copies/mL). For participants outside of mainland China, active, latent or incompletely treated infection with HBV or HCV;
    • Failed to complete anti-tuberculosis therapy at any point prior to C1D1; active tuberculosis infection, or still on anti-tuberculosis therapy;
    • Active syphilis infection requiring treatment;
    • Symptomatic congestive heart failure Grade II-IV ( [NYHA]), symptomatic or uncontrolled arrhythmias, (calculate using the Fridericia formula) >480 ms, or personal or family history of congenital long/short QT syndrome;
    • Uncontrollable hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg);
    • Active diseases, including but not limited to inflammatory bowel disease, autoimmune hepatitis, demyelinating lesions, extensive dermatitis, immunerelated interstitial pneumonia, or Grave's disease requiring antithyroid medication control (vitiligo, or hypothyroidism requiring hormone replacement therapy, type I diabetes requiring only insulin replacement therapy and no other systemic therapy in the past 2 years are eligible); Presence of clinically uncontrolled pleural/peritoneal effusions (participants who do not require regular drainage or who do not demonstrate significant re-accumulation of effusion for at least 72 hours after the most recent drainage can enroll).
  17. Major surgery within 2 weeks prior to the first dose of study treatment, not fully recovered from any prior surgery, or has non-minor surgery anticipated during the time the participant is expected to receive study drug or within 2 weeks after the last dose of study drug administration.
  18. Participating in any other interventional clinical research except an observational (noninterventional) study or the survival follow-up phase of an interventional study.
  19. Currently pregnant or breastfeeding.
  20. Any condition that would, in the Investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
  21. Inability to comprehend or unwilling to sign the ICF
Terms in these criteria, in plain language(32)

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.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

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.

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.

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).

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.

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.

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.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

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.

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.

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.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

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.

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.

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.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

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.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

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.

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.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

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.

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.

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
360 participants (estimated)

Study arms

  • Experimental
    IBI3003

    Participants will receive IBI3003 treatment until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal of consent for study participation, or end of the study or for a maximum of 24 months, whichever occurs first.

    Drug: IBI3003

Interventions

  • Participants will receive IBI3003 treatment until death, disease progression, intolerable toxicity, start of a new anticancer treatment, withdrawal of consent for study participation, or end of the study or for a maximum of 24 months, whichever occurs first.

06

What researchers measure

Primary outcomes

  1. Adverse events (AEs)

    Number of patients who Experienced related AEs from the first dose until 30 days after the last dose

    Time frame: Up to 30 days post last dose

  2. Dose limiting toxicities (DLTs)

    To evaluate the safety and tolerability of IBI3003

    Time frame: Up to 28 days post first dose

  3. ORR

    To evaluate the preliminary efficacy of IBI3003 in the specified participant population.

    Time frame: up to 24 months

  4. To determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3003

    To determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3003

    Time frame: up to 24 months

Secondary outcomes

  1. Incidence and characterization of anti-drug antibody (ADA).

    To evaluate the immunogenicity of IBI3003

    Time frame: up to 24 months

  2. Preliminary efficacy including objective response rate (ORR)

    objective response rate. To evaluate the preliminary efficacy of IBI3003 in the specified participant population.

    Time frame: up to 24 months

  3. To evaluate minimal residual disease (MRD) negativity rates. MRD negativity rate.

    To evaluate minimal residual disease (MRD) negativity rates.

    Time frame: up to 24 months

  4. efficacy estimates sCRR

    stringent complete response rate. To evaluate other efficacy estimates of IBI3003 in the participant population.

    Time frame: up to 24 months

  5. Incidence of TEAEs

    To evaluate the safety of IBI3003 in the participant population.

    Time frame: up to 24 months

  6. half-life (T1/2)

    To characterize the pharmacokinetic (PK) profile of IBI3003.

    Time frame: up to 24 months

  7. time to maximum concentration (Tmax)

    time to peak concentration. To characterize the pharmacokinetic (PK) profile of IBI3003.

    Time frame: up to 24 months

  8. maximum concentration (Cmax)

    up to 24 months

    Time frame: peak plasma concentration. To characterize the pharmacokinetic (PK) profile of IBI3003.

  9. area under the curve (AUC)

    area under the curve. To characterize the pharmacokinetic (PK) profile of IBI3003.

    Time frame: up to 24 months

  10. complete response rate (CRR)

    To evaluate the preliminary efficacy of IBI3003 in the specified participant population.

    Time frame: up to 24 months

  11. very good partial response rate (VGPRR)

    To evaluate the preliminary efficacy of IBI3003 in the specified participant population.

    Time frame: up to 24 months

  12. duration of response (DoR)

    To evaluate the preliminary efficacy of IBI3003 in the specified participant population.

    Time frame: up to 24 months

  13. disease control rate (DCR)

    To evaluate the preliminary efficacy of IBI3003 in the specified participant population.

    Time frame: up to 24 months

  14. time to response (TTR)

    up to 24 months

    Time frame: To evaluate the preliminary efficacy of IBI3003 in the specified participant population.

  15. progression free survival (PFS).

    To evaluate the preliminary efficacy of IBI3003 in the specified participant population.

    Time frame: up to 24 months

  16. SAEs

    serious adverse events (SAEs) Adverse events will be assessed by investigator(s) To evaluate the safety of IBI3003 in the participant population.

    Time frame: up to 24 months

  17. changes in laboratory parameters

    To evaluate the safety of IBI3003 in the participant population.

    Time frame: up to 24 months

  18. physical examination findings

    A complete physical examination will include: general appearance, respiratory, cardiovascular, abdomen, skin, head and neck (including ears, eyes, nose, and pharynx), lymph nodes, thyroid, musculoskeletal (including spine and extremities), genital/anal, and neurological assessments, if indicated. Clinically significant abnormal findings at screening will be recorded as medical history or AE based on the investigator's analysis and judgment.To evaluate the safety of IBI3003 in the participant population.

    Time frame: up to 24 months

  19. vital signs

    Collection of vital signs will include temperature in ℃, measurement tool is physiological parameter.To evaluate the safety of IBI3003 in the participant population.

    Time frame: up to 24 months

07

Study locations

4 of 6 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar 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 Jun 2027, 9 months later.

Of 98 industry-sponsored phase 1/2 interventional studies under Multiple Myeloma, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 90. This study's planned 9 months is below that.

Counting every sponsor, half of 201 studies reached it within 65 months; a quarter within 44 and three quarters within 92.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 25, 2026: start Apr 2026 → Sep 2026 and primary completion Dec 2027 → Jun 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

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

Registered
Jan 8, 2026
First posted
Jan 13, 2026
StartEst.
Sep 30, 2026was Apr 2026
Primary completionEst.
Jun 30, 2027was Dec 2027
CompletionEst.
Sep 30, 2028
Last update
Sep 25, 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.
Status
Not yet recruiting→Recruiting
changed Sep 25, 2026
Sites
6 sites added — first site in United States
Show 6 added (6 United States)
  • Honor Health · Scottsdale, United States
  • City of Hope - Duarte · Duarte, United States
  • City of Hope - Lennar · Irvine, United States
  • Emory · Atlanta, United States
  • Memorial Sloan Kettering · New York, United States
  • MD Anderson · Houston, United States
Sep 25, 2026
Start date
Apr 1, 2026→Sep 30, 2026
Sep 25, 2026
Primary completion
Dec 31, 2027→Jun 30, 2027
Sep 25, 2026
Contact
Study contact changed: a•••@fortvitabio.com · •••4296→c•••@fortvitabio.com · •••0985. See the current contact
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Not yet recruiting→Recruiting
    6 sites added — first site in United States
    Show 6 added (6 United States)
    • Honor Health · Scottsdale, United States
    • City of Hope - Duarte · Duarte, United States
    • City of Hope - Lennar · Irvine, United States
    • Emory · Atlanta, United States
    • Memorial Sloan Kettering · New York, United States
    • MD Anderson · Houston, United States
    Start date Apr 1, 2026→Sep 30, 2026
    Primary completion Dec 31, 2027→Jun 30, 2027
    Contact Study contact changed: a•••@fortvitabio.com · •••4296→c•••@fortvitabio.com · •••0985. See the current contact
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07336472
Responsible party
Sponsor
First posted
Jan 13, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Sep 30, 2028 (estimated)
Last update
Sep 25, 2026

Study contacts

Fortvita Biologics CT.gov Call Center
Contact
ct.govNotifications@fortvitabio.com
650-370-0985

Oversight

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

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Studies of the drug tested here: GPRC5D/BCMA/CD3-targeting T-cell Engager IBI3003

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