TerminatedPhase 1

A Study of bbT369 in Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma (NHL)

Stopped: Sponsor Decision

United States15 participantsStarted 2022-01-24

Plain-language summary

This non-randomized, open label, multi-site, first-in-human, Phase 1/2 study CRC-403 will evaluate the safety and efficacy of bbT369 in subjects with relapsed and/or refractory B cell non-Hodgkin's lymphoma (NHL). A long-term follow-up (LTF-01 \[NCT06798298\]) is planned, in which subjects who received bbT369 will be followed for up to 15 years after drug product infusion to evaluate for safety and continued efficacy.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. DLBCL (germinal center B cell \[GCB\] or activated B cell \[ABC\] type or not otherwise specified \[NOS\])
✓. HGBCL (with MYC and BCL2 and/or BCL6 rearrangements or NOS)
✓. PMBCL
✓. FL 3b
✓. DLBCL transformed from FL

What they're measuring

Phase 1: Incidence of safety events including: adverse events (AEs), adverse events of special interest (AESIs), and dose limiting toxicities (DLTs)

Timeframe: Day 1 through Month 24

Trial details

NCT IDNCT05169489

SponsorRegeneron Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-19

View on ClinicalTrials.gov More Diffuse Large B Cell Lymphoma (DLBCL) trials