Study of Naive HBI0101 CAR-T Therapy in Relapsed/Refractory Multiple Myeloma

NCT07333430 | Recruiting Phase 1 DMC

• 1 other identifier: Naive HBI0101-1 CAR-T
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsed/Refractory Multiple Myeloma (MM)

Keywords

Multiple Myeloma (MM)

Outcome Measures

Primary Outcomes (2)

• Determine the Maximum Tolerated Dose (MTD)

  MTD will be determined by dose limiting toxicities

  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.

  24 Months after infusion

Secondary Outcomes (6)

• Evaluate clinical response to Naïve HBI0101 CART

  24 Months after infusion

• Evaluate Overall Survival in participants treated with Naïve HBI0101 CART

  24 Months after infusion

• Evaluate Progression-Free Survival in participants treated with Naïve HBI0101 CART

  24 Months after infusion

• Evaluate Duration of Response in participants treated with Naïve HBI0101 CART

  24 Months after infusion

• Evaluate proportion of MRD negative subjects in participants treated with Naïve HBI0101 CART.

  24 Months after infusion

Study Arms (1)

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) .

Biological: Naive HBI0101 CAR-T

Interventions

Naive HBI0101 CAR-T BIOLOGICAL

Naïve HBI0101 CART is defined as autologous T cells transduced ex-vivo with anti-BCMA CAR retroviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA. The Naïve HBI0101 CART is provided cryopreserved.

CAR-T Naïve BCMA

Eligibility Criteria

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

You may qualify if:

• ≥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.
• 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

You may not qualify if:

• 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).
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah MO, Jerusalem, 9574869

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Polina Stepensky, MD

CONTACT

972-2-6778353; Fainak@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Polina Stepensky, Director Department of Bone Marrow Transplantation and Cancer Immunotherapy, Hadassah Medical Organization

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 12, 2026

Record last verified: 2025-12

Locations

IL (1)