RecruitingEarly phase 1interventionalRules rewrite

Early phase 1: testing IASO206 injection for Relapsed/Refractory Multiple Myeloma (RRMM)

This study is an open-label, single-arm early exploratory clinical study, aiming to measure the safety, tolerability and preliminary how well it works of IASO206 Injection(In Vivo CAR-T) in Patients with Relapsed/Refractory Multiple Myeloma

Official registry: https://clinicaltrials.gov/study/NCT07322159 · Institute of Hematology & Blood Diseases Hospital, China · enrollment listed as 18

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched 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 IASO206 injection. The registry lists allocation as na. This study is an open-label, single-arm early exploratory clinical study, aiming to measure the safety, tolerability and preliminary how well it works of IASO206 Injection(In Vivo CAR-T) in Patients with Relapsed/Refractory Multiple Myeloma

They plan to enroll about 18 people at Tianjin. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

An Exploratory Study of Safety and Efficacy of IASO206 in Patients With Relapsed/Refractory Multiple Myeloma

Interventions: IASO206 injection

Primary outcome (registry wording): The incidence and severity of adverse events（AEs）

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
18 to 75 years old, male or female;
Presence of measurable lesions during screening according to any of the following criteria:
Serum monoclonal protein (M-protein) level: ≥5 g/L f；
Urine M protein level ≥200 mg/24 hours;
Light chain multiple myeloma without measurable lesions in serum or urine: the affected serum free light chain ≥100 mg/L with abnormal serum κ/λ free light chain ratio;
BCMA expression on MM cells determined by flow cytometry or pathology immunohistochemistry;
Expected survival time ≥12 weeks;

Who the registry excludes

Patients with suspected or confirmed central nervous system involvement by plasma cell neoplasms;
Multiple myeloma patients with plasma cell leukemia;
Patients with amyloidosis;
Patients who have received autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks before enrollment, or have a history of allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
Patients who have received previous BCMA-targeted therapy;
Patients who have received plasma cell-targeted cellular therapy within 3 months before the screening period, or in whom received cellular therapy products can still be detected in peripheral blood;
Patients who have received other anti-tumor treatments requires an appropriate washout period：

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

1 listed

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, China (recruiting)

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FAQ about this NCT record

Is NCT07322159 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 NCT07322159?

Early phase 1. 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 NCT07322159?

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