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NCT07200089 · ClinicalTrials.gov registry record · Phase 1

Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel)

A Phase 1 study, sponsored by Washington University School of Medicine.

Recruiting
Registry status
Phase 1
Development phase
52
Enrollment target

NCT07200089: Recruiting Phase 1 study, sponsored by Washington University School of Medicine.

NCT07200089 is a Phase 1 study that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07200089, a Phase 1 study, is actively recruiting participants, sponsored by Washington University School of Medicine.

RECRUITING
Registry status
Phase 1
Development phase
52 participants
Enrollment target

Study Summary

CAR-T cell therapy is an emerging treatment modality in relapsed and refractory multiple myeloma (MM). CAR-T therapy in MM relies on directing autologous T-cells to detect and clear myeloma cells expressing B-cell Maturation Antigen (BCMA). While BCMA CAR-T cell-treated patients achieve an excellent overall response rate, their response is often not durable. NT-I7 promotes CAR-T cell expansion and efficacy in pre-clinical lymphoma models. In patients receiving CD19-directed CAR-T therapy for lymphoma, NT-I7 augmented CAR-T expansion while being safe and tolerable. The impact of NT-I7 on BCMA CAR-T cells in multiple myeloma is unknown. This is a two-stage, multicenter, phase IB study, with a dose escalation stage leading into a two-arm, double blind, placebo-controlled, randomized dose expansion stage testing the safety and toxicity of adding NT-I7 to BCMA CAR-T therapy in patients with relapsed and refractory multiple myeloma. The hypothesis is that NT-I7 will promote CAR-T expansion and persistence which will enhance clearance of MM, while maintaining a favorable safety and toxicity profile. Patients receiving standard of care BCMA CAR-T (cilta-cel) will be randomized to either NT-I7 or placebo. Correlative studies will evaluate CAR-T cell expansion, persistence, immune-phenotype, function and correlate with clinical outcomes.

Primary Outcome

Graded per CTCAE v 5.0.

Interventions

  • DRUG Placebo
  • DRUG NT-I7

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2026-06-05
Est. Completion 2028-12-31
Phase Phase 1

What NCT07200089 shows while recruiting

NCT07200089 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT07200089 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07200089 about?

NCT07200089 is a clinical study titled "Recombinant Human IL-7 (NT-I7) in Relapsed/Refractory Multiple Myeloma Following BCMA CAR-T Therapy (Cilta-cel)". CAR-T cell therapy is an emerging treatment modality in relapsed and refractory multiple myeloma (MM). CAR-T therapy in MM relies on directing autologous T-cells to detect and clear myeloma cells expressing B-cell Maturation Antigen (BCMA). While BCMA CAR-T cell-treated patients achieve an excellent...

What is the current status of trial NCT07200089?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2026-06-05. Estimated completion is 2028-12-31.

What interventions are being tested in trial NCT07200089?

The interventions under investigation include: Placebo (DRUG), NT-I7 (DRUG).

Who is sponsoring clinical trial NCT07200089?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07200089's enrollment target sits among peer trials

52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07200089, the US trial registry maintained by the National Library of Medicine. NCT07200089 (small enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.