TerminatedPhase 1

Phase I/II Clinical Study of 1A46 Drug Substance

Stopped: sponsor's Research and Development strategy adjustment

China4 participantsStarted 2023-09-12

Plain-language summary

A phase I/II, first in human, single arm, open label study to evaluate the safety and efficacy of the injection of triple-specific T-cell engager 1A46 in adult subjects with R/R CD20 positive and/or CD19 positive B cell non-Hodgkin's lymphoma (B - NHL)

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Aggressive NHL (aNHL) : MCL, each subtype of DLBCL and FL3b, PMBCL, high level of B cell lymphoma, etc.
✓. Indolent NHL (iNHL) : including FL1-3 a grade, MZL, small lymphocytic lymphoma, etc.
✓. all NHL patients should must: relapsed after or failed to respond to at least two prior systemic treatment regimens, including at least one containing an anti-CD20-directed therapy,, received or be ineligible for autologous SCT , there is no other standard treatment is thought to have clinical benefit

What they're measuring

Dose Limiting Toxicity (DLT) (Phase I)

Timeframe: Up to 4 weeks

Maximum tolerated dose (MTD) (Phase I)

Timeframe: Up to 4 weeks

Recommended phase 2 dose (RP2D) (Phase I)

Timeframe: Up to 48 weeks

Objective response rate (ORR) (Phase II)

Timeframe: Up to 48 weeks

Trial details

NCT IDNCT05987605

SponsorBioRay Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-20

View on ClinicalTrials.gov More Advanced Malignancies trials