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Study of Naive HBI0101 CAR-T Therapy in Relapsed/Refractory Multiple Myeloma | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Study of Naive HBI0101 CAR-T Therapy in 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

NCT07333430•Hadassah Medical Organization

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥18 years of age at the time of signing informed consent.
•2. Voluntarily signed informed consent form.
•3. 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):
•1. Serum M-protein greater or equal to 0.5 g/dL.
•2. Urine M-protein greater or equal to 200 mg/24 h.
•3. 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.
•4. A biopsy-proven evaluable plasmacytoma\*.
•5. Bone marrow plasma cells \> 10% of total bone marrow cells\*.
•6. Non secretory patient will be allowed provided they have measurable disease by PET-CT or bone marrow aspiration, as designated\*.
+11 more criteria

Exclusion Criteria

•1. Contraindication to a study treatment/procedure or is anticipated to receive treatment/procedure that may preclude performance of study procedures.
•2. Known bulky central nervous system disease.
•3. 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.
•4. Inadequate renal function defined by estimated clearance of \<20(ml/min).
•6. 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.
•7. Left ventricular ejection fraction \< 40%.
•8. 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)
•9. 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.
•10. Known human immunodeficiency virus (HIV) positive status.
•11. 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).
+9 more criteria

Locations (1)

Hadassah MO, Jerusalem, 9574869

Jerusalem, Israel

Key Dates

Start Date

January 15, 2026

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2030

Last Updated

January 12, 2026

Enrollment

ESTIMATED participants

Conditions

Relapsed/Refractory Multiple Myeloma (MM)

Interventions

Naive HBI0101 CAR-T

BIOLOGICAL

Contacts

Polina Stepensky, MD

CONTACT

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