Actively Recruiting
Study of Naive HBI0101 CAR-T Therapy in Relapsed/Refractory Multiple Myeloma
Led by Hadassah Medical Organization · Updated on 2026-01-12
60
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of Naive HBI0101 CAR-T Therapy in Relapsed/Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age at the time of signing informed consent.
- Voluntarily signed informed consent form.
- Diagnosis of relapsed or refractory multiple myeloma with measurable disease at screening defined by at least one of: serum M-protein 20.5 g/dL; urine M-protein 200 mg/24 h; serum free light chain level 3 mg/dL with abnormal ratio; biopsy-proven evaluable plasmacytoma; bone marrow plasma cells >10%; or measurable disease by PET-CT or bone marrow aspiration for non-secretory patients.
- Exposure to at least three prior lines of therapy including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody.
- For part 1a: presence of at least one risk factor including extra-medullary disease or previous anti-BCMA therapy.
- ECOG performance status between 0 and 2.
- Women of child-bearing potential must have a negative pregnancy test before treatment and agree to use effective birth control; all sexually active participants must agree to use birth control during the study.
- Recovery to Grade 2 or baseline of any non-hematologic toxicities from prior treatments, excluding alopecia and Grade 3 neuropathy, with no safety concerns per investigator.
- Ability and willingness to follow study visit schedule and protocol requirements.
- For subjects with prior allogenic stem cell transplant, no graft versus host disease after stopping immunosuppressive therapy for at least one month before recruitment.
You will not qualify if you...
- Contraindication to study treatment or anticipated treatments that prevent study procedures.
- Known bulky central nervous system disease.
- Liver function tests AST and/or ALT >2.5 times upper limit of normal or direct bilirubin >4 times upper limit.
- Renal function with clearance <20 ml/min.
- INR or PTT >2 times upper limit unless on stable anticoagulant for thromboembolic event.
- Bone marrow function with ANC <1000 cells/mm3, platelets <30,000/mm3, or hemoglobin <8 g/dL; absolute lymphocyte count <300 cells/mm3 may exclude.
- Left ventricular ejection fraction below 40%.
- Ongoing treatment with chronic immunosuppressants such as cyclosporine or systemic steroids (physiological steroid replacement doses allowed).
- Significant comorbid conditions or diseases posing undue risk or interfering with the study.
- Known HIV positive status.
- Active infections with Hepatitis B, Hepatitis C, or CMV.
- History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia needing medication or mechanical control within 3 months.
- Chronic atrial fibrillation with uncontrolled heart rate.
- Second primary malignancy requiring therapy in last 2 years or not in remission, except controlled basal cell or squamous cell skin carcinoma or prostate cancer under hormonal therapy.
- Venous thromboembolic event requiring anticoagulation with unstable anticoagulant use, recent significant hemorrhage, or ongoing symptoms.
- Pregnant or lactating women.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hadassah MO, Jerusalem, 9574869
Jerusalem, Israel
Actively Recruiting
Research Team
P
Polina Stepensky, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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