Bioheng Therapeutics Presents Promising Phase I Data of Allogeneic Anti-CD19 CAR-T Candidate RD06-03 in Relapsed/Refractory B-ALL at ASCO 2025

Recently, Bioheng Biotech announced at the 2025 American Society of Clinical Oncology（ASCO）At the annual meeting, the latest clinical data of RD06-03, a universal CAR-T cell therapy targeting CD19 for the treatment of R/R B-ALL patients, was presented in the form of an academic poster.

This ASCO conference reported data from a Phase I clinical study initiated by investigators. This single-arm, open-label, dose-escalation design study（NCT06307600）Evaluation of the Safety and Efficacy of RD06-03 in R/R B-ALL Patients. Dose escalation was conducted across four dose levels.（DL1: 0.1×10⁶ CAR⁺T cells/kg; DL2: 0.3×10⁶ CAR⁺T cells/kg; DL3: 0.5×10⁶ CAR⁺T cells/kg; EDL: 0.65×10⁶ CAR⁺T cells/kg）All patients received fludarabine before the infusion of RD06-03.（30 mg/m²/day*3 days)And Cyclophosphamide（500 mg/m²/day*3 Day）Clearing Pre-treatment Regimen.

From March 17, 2024, to October 25, 2024, the center enrolled a total of 6 patients with R/R B-ALL, with a median age of 37.5 years.(Range: 18-63), with a median of 3 prior treatment lines(Range: 2-8+)One patient had previously undergone allogeneic hematopoietic stem cell transplantation. The median percentage of baseline bone marrow tumor cells was 41.9%.(Range: 10%-88.5%)。

No DLT or neurotoxicity was observed at any dose level. CRS occurred in four patients, all of which were mild.（G1，n=4）, median duration 2.5 days(Range: 1-4 days)The most common TEAE was a decrease in blood cell count, which was manageable in severity, and no serious infection-related adverse events occurred.

Among the 5 evaluable patients at DL2 and higher dose levels, the best ORR reached 100%.（5/5）, all patients in remission reached MRD-negative status. As of May 5, 2025, the median follow-up time was 8.5 months.(Duration: 2-11 months), The median DOR was not reached, and the longest DOR was 10.1 months. All patients receiving ≥DL2 dose levels showed CAR-T cell expansion as observed by qPCR, with a median Cmax exceeding 1,000,000 copies/μg gDNA, a median persistence of 28 days, and the longest persistence exceeding 3 months.

Overall, RD06-03 was well-tolerated in R/R B-ALL patients, with significant expansion and high response rates achieved at lower dose levels under standard lymphodepletion regimens. Additionally, as an "off-the-shelf" universal CAR-T cell candidate product without HLA matching requirements, RD06-03 still maintained favorable in vivo persistence characteristics, with CAR-T cells detectable in 50% of patients on Day 30, and the longest persistence exceeding 3 months. TCR/HLA gene editing and ANSWER^®The platform significantly enhances the anti-rejection capability of RD06-03, which is of great significance in the field of universal CAR-T cell therapy research.

Nanjing Bioheng Biotech Co., Ltd. has initiated research on this candidate product in the field of autoimmune diseases in the second quarter of 2024, with early data also showing positive results.

RD06-03 is a universal CAR-T cell candidate product derived from healthy donors, targeting CD19, for the treatment of relapsed or refractory acute B lymphoblastic leukemia, which avoids graft-versus-host disease through genetic modification.（GvHD）Host Anti-Graft Rejection（HvG）, while enhancing anti-tumor activity. RD06-03 can be prepared in a single batch for multiple uses, achieving the goal of "ready-to-use" whenever patients require CAR-T cell therapy.

Nanjing Bioheng Biotech Co., Ltd. is a company focused on allogeneic..."Ready-to-use" AccessA clinical-stage company developing CAR-T therapies. Founded in 2017, the company is committed to developing world-leading allogeneic cell therapy platforms and products to address significant unmet clinical needs in areas such as hematologic malignancies and autoimmune diseases.

Editorial Responsibility | Yong

Proofread by Jiebolian

Exciting Live Broadcast Preview

Press and hold to scan the QR code to participate immediately ↓

Swipe up to view

Recommendation 1

June 4th, 14:00-15:00

Controlled Ice Cryopreservation Technology Provides an Efficient and Safe Precision Cryopreservation Solution for Cell Therapy

Recommendation 2

June 5th, 19:00-20:30

Focus on Biosafety and Quality Control Innovation in AAV Gene Therapy Products

DianDian "Share”、“Like"and"In View", give me a little recharge~"