Clinical Trial Results

Shanghai – September 25, 2026 -- IASO Biotechnology reported an 88.9% objective response rate for its dual-targeted CAR-T therapy RD140 in a first-in-human Phase 1 trial of nine heavily pretreated multiple myeloma and plasma cell leukemia patients, with the response rate reaching 100% in the higher-dose cohort.

RD140 achieves 88.9% MRD negativity in high-risk relapsed patients

The investigator-initiated trial (NCT06655519), led by Professor Jin Lu of Peking University People's Hospital, enrolled patients who had failed at least three prior lines of therapy, including two who had previously received BCMA-targeted treatment. All nine patients were triple-class exposed, and six were penta-exposed. As of the May 6, 2026 data cutoff, with a median follow-up of 6.05 months, 88.9% of patients achieved MRD negativity at the 10−5 threshold, with six reaching this benchmark as early as day 28. Median progression-free survival has not been reached.

Raritan, N.J. – September 25, 2026 -- Half of patients with early-line relapsed or refractory multiple myeloma treated with a single infusion of Johnson & Johnson's CARVYKTI® (ciltacabtagene autoleucel) remained alive and progression-free for at least five years without maintenance therapy, according to new long-term data from the Phase 2 CARTITUDE-2 study.

Half of patients reach five-year progression-free survival without maintenance

In the initial subgroup of cohort A (N=20), 10 of 20 patients treated with a single CARVYKTI® infusion remained progression-free at a median follow-up of 60.7 months. Median progression-free survival reached 60.5 months, and the results were presented at the International Myeloma Society Annual Meeting (Abstract #PA-288). Cohort A enrolled patients who had received one to three prior lines of therapy, were exposed to a proteasome inhibitor, and were refractory to lenalidomide.

Rockville, Md. – September 24, 2026 -- REGENXBIO Inc. (Nasdaq: RGNX) reported that 60% of Dose Level 3 participants with three-year follow-up data in its Phase II ALTITUDE study achieved a greater-than-2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS) after a single in-office treatment with investigational gene therapy sura-vec, with no vision-threatening events recorded among responders.

Three-year data confirm durable DRSS improvement without repeat injections

In long-term follow-up as of August 17, 2026, six of ten Dose Level 3 participants with non-proliferative diabetic retinopathy (NPDR) who reached the three-year visit sustained a greater-than-2-step DRSS improvement without additional diabetic retinopathy treatment. The suprachoroidal delivery used Dose Level 3 (1.0x10^12 GC/eye) combined with short-course prophylactic topical steroids.

Dover, Del. – September 24, 2026 -- Clywedog Therapeutics, Inc. reported that its investigational menin inhibitor balomenib produced a placebo-adjusted mean HbA1c reduction of 0.77% at Week 12 (p0.01) and 0.70% at Week 16 (p0.05) in a Phase 1b trial, effects recorded three months after the drug's final dose following just three weeks of treatment.

Boston – September 23, 2026 -- CSA Medical, Inc. announced publication in the American Journal of Respiratory and Critical Care Medicine of pivotal SPRAY-CB trial results showing its RejuvenAir System reduced severe COPD exacerbation rates by 38.4% versus a sham control.

Trial enrolled 210 patients across the US and UK despite optimal medical therapy

The randomized, blinded, sham-controlled SPRAY-CB trial (NCT03893370) tested Metered CryoSpray (MCS) therapy in patients with moderate-to-severe COPD and symptomatic chronic bronchitis who remained highly symptomatic despite receiving standard-of-care medication.

Suzhou, China – September 23, 2026 -- Innovent Biologics (HKEX: 01801) will present late-breaking Phase 3 data for its CLDN18.2-targeting antibody-drug conjugate IBI343/TAK-921 at the 2026 European Society for Medical Oncology (ESMO) Annual Meeting in Madrid, running October 23-27.

Phase 3 gastric cancer trial secures late-breaking oral slot

Results from the registrational G-HOPE-001 study, comparing Arcotatug Tavetecan against treatment of physician's choice in previously treated advanced gastric or gastroesophageal junction adenocarcinoma, will be delivered as a late-breaking abstract (LBA77) during the October 23 proffered paper session. Dr. Kohei Shitara of Chiba, Japan, will present the first interim analysis of the randomized, open-label trial.

New Taipei City – September 23, 2026 -- Caliway Biopharmaceuticals (TWSE: 6919) said on September 21 that its Phase 2 CBL-0202DD trial of CBL-514 met its primary efficacy endpoint, delivering statistically significant pain reduction in patients with Dercum's Disease compared with placebo, in both the Full Analysis Set (FAS) and Per-Protocol (PP) populations.

CBL-514 Cuts Pain Scores by 3.1 Points at Week 20 Versus Placebo

In the FAS population, patients treated with CBL-514 achieved a mean pain-score reduction of 3.1 points at Week 20, versus 1.9 points for placebo (p=0.005). In the PP population, the same 3.1-point reduction was measured against a 1.4-point placebo response (p=0.0002).

Hong Kong – September 21, 2026 -- Akeso, Inc. (9926.HK) will present nearly 30 clinical studies of its bispecific antibodies at the European Society for Medical Oncology (ESMO) Congress in Madrid on October 23-27, 2026, including a Late-Breaking Abstract selected for the Presidential Symposium.

Phase III biliary tract cancer trial secures Presidential Symposium slot

Overall survival results from the Phase III HARMONi-GI1 trial, comparing ivonescimab plus chemotherapy against durvalumab plus chemotherapy as a first-line treatment for advanced biliary tract cancer, will be delivered as a late-breaking oral presentation (LBA8) on October 25 at 16:30-18:15 in Madrid. The presentation will be given by Jian Zhou of Shanghai during Presidential Symposium II.

Beijing – September 21, 2026 -- T-MAXIMUM Pharmaceutical reported that two of three evaluable patients with refractory brain metastases from lung cancer achieved partial responses with roughly 80% tumor shrinkage after treatment with its allogeneic B7-H3-targeted CAR-T therapy, MT027, according to early data presented at the IASLC World Conference on Lung Cancer (WCLC 2026) in Seoul.

Two of three evaluable patients hit 80% tumor shrinkage in dose-escalation trial

In the prospective, investigator-initiated trial (ChiCTR2500107346), five patients with heavily pretreated, guideline-exhausted brain metastases completed treatment. Of the three with measurable disease, two achieved partial responses and one achieved stable disease. As of the company's September 2026 follow-up, the two responders have survived more than 11 and 13 months, respectively, since their first MT027 dose, and all three evaluable patients remain alive.

Las Vegas – September 21, 2026 -- Concept Medical's MagicTouch sirolimus-coated balloon will face fresh scrutiny at VIVA 2026 as researchers unveil new subgroup data from the SirPAD randomized trial covering 597 patients treated for femoropopliteal peripheral artery disease without tissue loss.

SirPAD enrolled 1,252 patients to compare drug-coated and uncoated balloon angioplasty

The academic, investigator-initiated trial randomized 1,252 patients with symptomatic infrainguinal peripheral artery disease to angioplasty using either the MagicTouch PTA sirolimus-coated balloon or an uncoated balloon. Primary results, published in the New England Journal of Medicine, showed the sirolimus-coated balloon arm was both non-inferior and superior to the uncoated balloon on major adverse limb events (MALE) at one year.