Relapsed/Refractory Multiple Myeloma (MM)Phase 1NCT07333430
Study of Naive HBI0101 CAR-T Therapy in Relapsed/Refractory Multiple Myeloma
A Phase 1 study testing Naive HBI0101 CAR-T in people with Relapsed/Refractory Multiple Myeloma (MM), run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
A Phase 1a/1b Open-Label Study with Dose Escalation and Expansion Phases to Evaluate Safety and Preliminary Efficacy of Naïve HBI0101 CART Therapy for the Treatment of Relapsed/Refractory Multiple Myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma (MM)
- What is being tested?
- Naive HBI0101 CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 7 Jan 2026to 1 Dec 2030
- 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
- ≥18 years of age at the time of signing informed consent.
- Voluntarily signed informed consent form.
- Diagnosis of relapsed/refractory multiple myeloma (Parts 1a and 1b), with measurable disease at screening visit as follows:
- Multiple Myeloma (at least one of the criteria below):
- Serum M-protein greater or equal to 0.5 g/dL.
- Urine M-protein greater or equal to 200 mg/24 h.
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- Serum free light chain (FLC) assay: involved FLC level greater or equal to 3 mg/dL (30 mg/L) provided serum FLC ratio is abnormal.
- A biopsy-proven evaluable plasmacytoma*.
- Bone marrow plasma cells > 10% of total bone marrow cells*.
- Non secretory patient will be allowed provided they have measurable disease by PET-CT or bone marrow aspiration, as designated*.
- Results pre-dating the Screening visit by up to 28 days may be used to establish eligibility.
- R/R MM subjects must have been exposed to at least three prior lines of therapy including the following agents:
- proteasome inhibitor
- immunomodulatory (IMiDs) agent
- anti-CD38 antibody
- For part 1a: At least one of the following risk factors: a. Extra-medullary disease (EMD) - defined as a MM lesion that is not connected to a bone. b. previous exposure to an anti-BCMA therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
- Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study.
- Recovery to ≤ Grade 2 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 3 neuropathy, and toxicities that are irreversible and not expected to interfere with study treatment or pose safety concerns, per investigator judgement.
- Ability and willingness to adhere to the study visit schedule and all protocol requirements.
- For subjects with relapsed multiple myeloma who have previously undergone allogenic stem cell transplantation: no evidence of graft versus host disease after cessation of any immunosuppressive therapy for at least one month before recruitment to the study.
Who cannot join
- Contraindication to a study treatment/procedure or is anticipated to receive treatment/procedure that may preclude performance of study procedures.
- Known bulky central nervous system disease.
- Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN) and/or direct bilirubin > 4x ULN.
- Inadequate renal function defined by estimated clearance of <20(ml/min).
- International ratio (INR) or partial thromboplastin time (PTT) > 2 x ULN, unless on a stable dose of anticoagulant for a thromboembolic event (provided this event is not an exclusion criteria).
- Inadequate bone marrow function defined by absolute neutrophil count (ANC) < 1000 cells/mm3, platelet count < 30,000 mm3, or hemoglobin < 8 g/dL. Subjects with absolute lymphocyte count < 300 cells/mm3 may be excluded (due to potential challenges with producing CART), per investigator judgement.
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- Left ventricular ejection fraction < 40%.
- Ongoing treatment with chronic immunosuppressant such as cyclosporine or systemic steroids (physiological replacement doses of steroids are allowed up to 12 mg/m2/d hydrocortisone or equivalent)
- Significant co-morbid condition or disease which in the judgment of the Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions.
- Known human immunodeficiency virus (HIV) positive status.
- Active Hepatitis B active infection (defined as HBS-antigen and HBV DNA positive) or Hepatitis C active infection (defined as anti-HCV and HCV RNA positive).
- Active CMV infection.
- Known history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within 3 months.
- Chronic atrial fibrillation with uncontrolled heart rate.
- Second primary malignancy that has required therapy in the last 2 years or is not in complete remission. This exclusion criterion does not exclude the following subjects: successfully treated non- metastatic basal cell or squamous cell skin carcinoma, or prostate cancer under control with hormonal therapy
- Subjects who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation and who meet any of the following criteria:
- Have been on a stable dose of anticoagulation for < 1 month (except for acute line insertion induced thrombosis.
- Have had a Grade 2, 3, or 4 hemorrhage in the last 30 days
- Are experiencing continued symptoms from their venous thromboembolic event (e.g. continued dyspnea or oxygen requirement).
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Hadassah MO, Jerusalem, 9574869
Jerusalem
Polina Stepensky, MD, +97226776679, Fainak@haddasah.org.il
Polina Stepensky, MD
About this study
Official title: A Phase 1a/1b Open-Label Study With Dose Escalation and Expansion Phases to Evaluate Safety and Preliminary Efficacy of Naïve HBI0101 CART Therapy for the Treatment of Relapsed/Refractory Multiple Myeloma
A Phase 1a/1b Open-Label Study with Dose Escalation and Expansion Phases to Evaluate Safety and Preliminary Efficacy of Naïve HBI0101 CART Therapy for the Treatment of Relapsed/Refractory Multiple Myeloma.
- Being tested
- Naive HBI0101 CAR-T
- Keywords
- Multiple Myeloma (MM)
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naive HBI0101 CAR-TBiological
Naive HBI0101 CAR-T is an autologous anti-BCMA CAR-T-cell product manufactured using a CD62L-based magnetic enrichment strategy to generate CAR-T cells enriched in naïve and early-memory T-cell populations. Peripheral blood mononuclear cells (PBMCs) collected by leukapheresis undergo magnetic selection for CD62L-expressing cells prior to T-cell activation, retroviral transduction with a chimeric antigen receptor (CAR) targeting human B-cell maturation antigen (BCMA), and ex vivo expansion. The final CAR-T-cell product is cryopreserved before administration.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T Naïve BCMA | Experimental | The dose escalation phase (Part 1a) will follow a 3+3 design and include up to 3 dose level cohorts. Eligible participants for Cohorts 1, 2, and 3 will receive a single (low, medium or high) dose of 80 × 106 ± 30%, 160 × 106 ± 25% and 240 × 106 ± 20% Naïve HBI0101 CART.
The expansion phase (Part 1b) will receive up to Maximum Tolerated Dose (MTD) . Receives: Biological: Naive HBI0101 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the Maximum Tolerated Dose (MTD)
MTD will be determined by dose limiting toxicities
Measured: 21 days after infusion
Evaluate safety of Naïve HBI0101 CART in Parts 1a and 1b
Incidence of Serious Adverse Events and Adverse Events of Special Interest related to study treatment.
Measured: 24 Months after infusion
Secondary outcomes (6)
Evaluate clinical response to Naïve HBI0101 CART
Overall response rate- Percentage of participants who achieved at least partial response
Measured: 24 Months after infusion
Evaluate Overall Survival in participants treated with Naïve HBI0101 CART
Measured: 24 Months after infusion
Evaluate Progression-Free Survival in participants treated with Naïve HBI0101 CART
Measured: 24 Months after infusion
Evaluate Duration of Response in participants treated with Naïve HBI0101 CART
Measured: 24 Months after infusion
Evaluate proportion of MRD negative subjects in participants treated with Naïve HBI0101 CART.
Measured: 24 Months after infusion
Evaluate persistence of Naïve HBI0101 CART in treated participants
Quantification of Naïve HBI0101 CART in the blood
Measured: 24 Months after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start7 Jan 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple Myeloma (MM)Studies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Polina Stepensky, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333430
- Sponsor's protocol ID
- Naive HBI0101-1 CAR-T
- Status last verified
- Oct 2026
- First submitted
- 30 Dec 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Open-Label Study With Dose Escalation and Expansion Phases to Evaluate Safety and Preliminary Efficacy of Naïve HBI0101 CART Therapy for the Treatment of Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07333430
- Acronym / sponsor ID
- Naive HBI0101-1 CAR-T
- Keywords
- Multiple Myeloma (MM)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 12 Jan 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.
A Phase 1a/1b Open-Label Study with Dose Escalation and Expansion Phases to Evaluate Safety and Preliminary Efficacy of Naïve HBI0101 CART Therapy for the Treatment of Relapsed/Refractory Multiple Myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T Naïve BCMA | Experimental | Biological: Naive HBI0101 CAR-TThe dose escalation phase (Part 1a) will follow a 3+3 design and include up to 3 dose level cohorts. Eligible participants for Cohorts 1, 2, and 3 will receive a single (low, medium or high) dose of 80 × 106 ± 30%, 160 × 106 ± 25% and 240 × 106 ± 20% Naïve HBI0101 CART. The expansion phase (Part 1b) will receive up to Maximum Tolerated Dose (MTD) . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- ≥18 years of age at the time of signing informed consent.
- Voluntarily signed informed consent form.
- Diagnosis of relapsed/refractory multiple myeloma (Parts 1a and 1b), with measurable disease at screening visit as follows:
- R/R MM subjects must have been exposed to at least three prior lines of therapy including the following agents:
- For part 1a: At least one of the following risk factors: a. Extra-medullary disease (EMD) - defined as a MM lesion that is not connected to a bone. b. previous exposure to an anti-BCMA therapy.
Key exclusion criteria (20 listed)
- Contraindication to a study treatment/procedure or is anticipated to receive treatment/procedure that may preclude performance of study procedures.
- Known bulky central nervous system disease.
- Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN) and/or direct bilirubin > 4x ULN.
- Inadequate renal function defined by estimated clearance of <20(ml/min).
- International ratio (INR) or partial thromboplastin time (PTT) > 2 x ULN, unless on a stable dose of anticoagulant for a thromboembolic event (provided this event is not an exclusion criteria).
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 |
|---|---|---|
| Naive HBI0101 CAR-TNaive HBI0101 CAR-T is an autologous anti-BCMA CAR-T-cell product manufactured using a CD62L-based magnetic enrichment strategy to generate CAR-T cells enriched in naïve and early-memory T-cell populations. Peripheral blood mononuclear cells (PBMCs) collected by leukapheresis undergo magnetic selection for CD62L-expressing cells prior to T-cell activation, retroviral transduction with a chimeric antigen receptor (CAR) targeting human B-cell maturation antigen (BCMA), and ex vivo expansion. The final CAR-T-cell product is cryopreserved before administration. | Biological | CAR-T Naïve BCMA |
Primary outcome
Determine the Maximum Tolerated Dose (MTD)
Time frame: 21 days after infusion
MTD will be determined by dose limiting toxicities
Evaluate safety of Naïve HBI0101 CART in Parts 1a and 1b
Time frame: 24 Months after infusion
Incidence of Serious Adverse Events and Adverse Events of Special Interest related to study treatment.
6 secondary outcomes
Evaluate clinical response to Naïve HBI0101 CART
Time frame: 24 Months after infusion
Evaluate Overall Survival in participants treated with Naïve HBI0101 CART
Time frame: 24 Months after infusion
Evaluate Progression-Free Survival in participants treated with Naïve HBI0101 CART
Time frame: 24 Months after infusion
Evaluate Duration of Response in participants treated with Naïve HBI0101 CART
Time frame: 24 Months after infusion
Evaluate proportion of MRD negative subjects in participants treated with Naïve HBI0101 CART.
Time frame: 24 Months after infusion
Evaluate persistence of Naïve HBI0101 CART in treated participants
Time frame: 24 Months after infusion
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 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naive HBI0101 CAR-T in people with Relapsed/Refractory Multiple Myeloma (MM), run by Hadassah Medical Organization at 1 site in Israel.
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 21 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Polina Stepensky, MD (972-2-6778353, Fainak@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the Maximum Tolerated Dose (MTD) (time frame: 21 days after infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.