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Engineered immune cells take aim at multiple myeloma from the start

NCT ID NCT07652138

Disease control Sponsor: The First Affiliated Hospital of Soochow University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests a new treatment called RN1201 for people newly diagnosed with multiple myeloma, a type of blood cancer. RN1201 uses specially engineered immune cells from a healthy donor to target and kill cancer cells. Participants receive a single infusion of these cells after a short course of chemotherapy. The main goal is to check the safety of this approach and to see how well it controls the cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RN1201 (allogeneic CAR-T cells targeting BCMA and CD19)
What this could lead to
If successful, this could offer a powerful one-time cell therapy for newly diagnosed multiple myeloma, potentially reducing or eliminating the need for ongoing treatment.
What could go wrong
This is a very early, small Phase 1 trial focused on safety, so effectiveness is not yet known. CAR-T therapies can cause serious side effects like cytokine release syndrome and neurological issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Willingness to participate in the trial and provide written informed consent. * 2\. Diagnosis of multiple myeloma (MM) per the 2017 revised WHO criteria. * 3\. BCMA-positive multiple myeloma documented at screening or in prior medical records. * 4\. Aged 18 - 70 years, any gender. * 5\. Life expectancy of at least 12 weeks. * 6\. Serum total bilirubin \< twice the upper limit of normal (ULN); serum creatinine within normal range; * 7\. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< three times ULN. * 8\. ECOG performance status score of 0 - 2. * 9\. Left ventricular ejection fraction (LVEF) ≥50% with no pericardial effusion. * 10\. Ability to adhere to the study visit schedule and protocol requirements. Exclusion Criteria: 1. Patients with serious active infections. * 2\. Subjects with acquired or congenital immunodeficiency. * 3\. Subjects with Class III/IV heart failure per NYHA criteria. * 4\. Subjects with epilepsy or other central nervous system diseases. * 5\. Subjects with a history of primary cancer, except: 1. Resected non-melanoma (e.g., basal cell carcinoma) 2. Cured carcinoma in situ (e.g., cervical, bladder, breast cancer) * 6\. Systemic high-dose steroid use within 2 weeks before treatment. * 7\. Pregnant, breastfeeding women, or those planning pregnancy in 6 months. * 8\. Participation in other clinical trials within one month. * 9\. Major surgery within 14 days before the first study drug dose. * 10\. Any condition the investigator deems may raise subject risks or affect trial results.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myloma Newly diagnosed multiple myeloma (NDMM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.