Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing HBI0101 CART for Multiple Myeloma, Refractory to Standard Treatment

A Phase II study of HBI0101 (NXC-201) BCMA-CART in Multiple Myeloma and Light-chain Amyloidosis Patients. The goal of the study is to measure the how well it works and safety of HBI0101 CART.

Official registry: https://clinicaltrials.gov/study/NCT06971380 · Polina Stepensky · enrollment listed as 180

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are HBI0101 CART. The registry lists allocation as na. A Phase II study of HBI0101 (NXC-201) BCMA-CART in Multiple Myeloma and Light-chain Amyloidosis Patients.

They plan to enroll about 180 people at Jerusalem. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

A Phase 2 Trial to Study Efficacy and Safety of HBI0101 (NXC-201) CART in Subjects With Multiple Myeloma and Light-Chain Amyloidosis.

Interventions: HBI0101 CART

Primary outcome (registry wording): Clinical response to HBI0101 CART

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Diagnosis of multiple myeloma and/or light-chain amyloidosis with relapsed or refractory disease, with measurable disease at screening visit
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
  • Recovery to ≤ Grade 2 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 3 neuropathy
  • Ability and willingness to adhere to the study visit schedule and all protocol requirements
  • Subjects with relapsed multiple myeloma who have previously undergone allogenic stem cell transplantation must have no evidence of graft versus host disease after cessation of any immunosuppressive therapy for at least one month before recruitment to the study

Public study contact (from the registry)

Polina Stepensky, MD

972-2-6778353

Fainak@hadassah.org.il

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Related recruiting trials in this snapshot

RecruitingPhase 1La Jolla, California
Phase 1: testing Linvoseltamab for Multiple Myeloma

This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after prior therapies and needed to be treated again.

NCT05137054 · Official ClinicalTrials.gov record · Regeneron Pharmaceuticals

FAQ about this NCT record

Is NCT06971380 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06971380?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06971380?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary