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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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

• 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.

Locations
Other Locations
Israel
Hadassah MO, Jerusalem, 9574869
RECRUITING
Jerusalem
Contact Information
Primary
Polina Stepensky, MD
Fainak@hadassah.org.il
972-2-6778353
Time Frame
Start Date: 2026-01-15
Estimated Completion Date: 2030-12-01
Participants
Target number of participants: 60
Treatments
Experimental: CAR-T Naïve BCMA
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) .
Related Therapeutic Areas
Sponsors
Leads: Hadassah Medical Organization

This content was sourced from clinicaltrials.gov