Entering 2026, the universal CAR-T track is experiencing a significant rebound in temperature.

In April of this year, Allogene released negative MRD data, which excited the market; Recently, Caribou Biosciences has added fuel to this trend with a median PFS data of 17.1 months, further verifying the strength of generic therapies in terms of durability comparable to autologous CAR-T.

A few years ago, the universal CAR-T was one of the hottest tracks in the CGT field, but with the first batch of clinical data for key projects falling short of expectations, the popularity of this technology field has declined in the past two to three years, and the track has entered a "disillusionment trough", with investment cooling down and a large number of companies leaving.
After undergoing rigorous market washing and screening, now, with a few "perseverers" achieving further breakthroughs, the universal CAR-T has once again entered the "climbing recovery period" - the industry is regaining confidence through the continuous accumulation of clinical data.

Caribou is not an isolated case, and the 2026 EHA has almost become a "runway" for universal CAR-T, with at least 10 related studies on universal CAR-T pipelines published, covering multiple key targets of hematological malignancies such as BCMA, CD19, CD20, CD7, presenting a dense breakthrough trend of multiple pipelines, targets, and indications.

However, with the current explosion of CAR-T in the body, what does the warming of this universal CAR-T mean? When "in-vivo CAR-T" is crowned with the halo of "next-generation disruptive technology", the industry begins to re-examine the position of universal CAR-T - is it a necessary path to the popularization of cell therapy, or a transitional existence before the birth of more advanced technologies? How long will the lifecycle of this type of product last?

01、Data confidence of Visa Cell

Vispacabtagene regedleucel (formerly known as CB-010) under Caribou is a universal CAR-T therapy targeting CD19, indicated for relapsed or refractory B-cell non Hodgkin lymphoma (r/r B-NHL).

It is reported that vispa cel is the first allogeneic CAR-T therapy carrying PD-1 gene knockout in clinical practice. The original intention of designing this genome editing strategy is to enhance the anti-tumor activity of CAR-T cells by limiting their premature exhaustion. The FDA has granted vispa cel three qualifications for advanced regenerative medicine therapy (RMAT), fast track, and orphan drug indications in B-NHL.

The data released this time is based on 27 patients with second-line large B-cell lymphoma (LBCL). All patients received a single dose of 80 million optimized CAR-T cells for treatment. The so-called "optimization" refers to Caribou screening donor cells under the age of 30 with at least two human leukocyte antigen (HLA) alleles that match the patient.

In terms of efficacy, the objective response rate (ORR) of 27 patients was 82%, the complete response rate (CR) was 67%, and the median PFS was 17.1 months. In terms of safety, the overall tolerance is good, and there has been no occurrence of graft-versus-host disease (GvHD) or grade 3 or above immune effector cell associated neurotoxicity syndrome (ICANS).
It should be noted that Caribou has previously disclosed two deaths: one related to vispa cel and died from immune effector cell associated hemophagocytic lymphohistiocytosis like syndrome (HLH like syndrome); Another case died from progressive multifocal leukoencephalopathy (PML), which was assessed to be possibly related to CAR-T therapy.

In terms of key indicators, the median PFS of vispa cel at 17.1 months is comparable to the historical data of autologous CAR-T - Breyanzi at BMS at 14.8 months and Yescarta at Kite, a subsidiary of Gilead, at 14.9 months.

However, Caribou management is also aware that the existing data is not sufficient to prove the superiority of vispa cel. The real betting logic is that as long as the universal therapy can achieve efficacy comparable to the self, combined with the differentiated advantage of spot supply, it is enough to cut its own market share.

Caribou CEO Rachel Haurwitz once stated in an interview that although autologous CAR-T is the "undisputed gold standard treatment," the harsh reality is that only about 25% of second-line LBCL patients ultimately receive this treatment - in other words, three-quarters of patients are left out.

This is precisely the "bullseye" of visco cel - in the key phase III trial design of ANTLER-3, which has reached consensus with the FDA, Caribou specifically targeted another 75% of patients - a group of patients who cannot accept autologous CAR-T due to medical or accessibility issues such as rapid disease progression, difficulty in blood collection, and living far from treatment centers.

Haurwitz pointed out that for these patients, the value of spot therapy is not only the convenience of adding icing on the cake, but also the accessibility of providing timely assistance. Visa cel is expected to eliminate the time lag from prescription to treatment; And Caribou plans to include community hospitals in the Phase III trial center, attempting to bring cell therapy closer to inclusive healthcare.

ANTLER-3 is expected to be conducted in approximately 75 clinical trial centers worldwide, involving around 250 second-line LBCL patients who have not previously received CD19 targeted therapy. Inclusion criteria include unsuitability for transplantation, inability to use autologous CAR-T due to medical conditions or accessibility issues, and urgent need for treatment.

 

02、Universal CAR-T Breakthroughs Across the Entire Line

The efficacy data of vispa cel is just a footnote to the recent increase in the temperature of universal CAR-T therapy. Since 2026, this track is accelerating its breakthrough in clinical progress and indications expansion.

Looking at the world, the fastest progressing universal CAR-T product currently is Wugen's WU-CART-007. This CD7 targeted product has completed Phase I/II research and is currently in the critical Phase II single arm trial (T-RRex) stage. It has obtained FDA breakthrough therapy certification and is scheduled to submit a BLA in 2027. It is expected to become the world's first universal CAR-T for T-cell malignancies to be declared for market.

Allogene Therapeutics released the first batch of data from the Phase II ALPHA3 trial of its universal CAR-T product CEMA CEL in April this year.

In patients with large B-cell lymphoma who still have minimal residual lesions (MRD) after first-line chemotherapy, the conversion rate of MRD to negative in the CEMA cel group on day 45 of treatment was 58.3%, while in the control group it was only 16.7%, with an absolute difference of 41.6 percentage points. In terms of safety, no level of CRS, ICANS, or GvHD was observed, and 10 out of 12 patients completed the infusion in the outpatient department.

On the global track, the "leader" and the "challenger" each hold their own position; On the other side of the ocean, the presence of Chinese companies is also active. At the 2026 EHA and recent academic conferences, Chinese general CAR-T companies demonstrated strong differentiation competitiveness - not only continuing to deepen their cultivation in the field of hematological malignancies, but also seizing the opportunity in the new battlefield of autoimmune diseases.

Keji Pharmaceutical has released the latest data on two core pipelines (CT0596 and CT1190B) in the form of a poster at this year's EHA.

CT0596 is a allogeneic universal CAR-T targeting BCMA, developed based on its own THANK-u Plus platform. A total of 8 patients received treatment, including 6 patients with relapsed/refractory multiple myeloma and 2 patients with relapsed/refractory primary plasma cell leukemia.

As of May 10, 2026, 6 patients achieved strict complete remission or very good partial remission after the first infusion, including 2 pPCL patients who achieved sCR, 4 MM patients who achieved sCR, 1 VGPR, and 1 PR. All patients achieved MRD negative sensitivity of 10 ⁻ 4 weeks after effective infusion.

In terms of safety, all 8 patients reported adverse events (TEAEs) during treatment, mainly hematological toxicity, which is a common adverse event after CAR-T infusion. No grade ≥ 3 CRS, ICANS, or GvHD occurred. No patients withdrew from the trial or died due to adverse events.

The other core pipeline CT1190B targets CD19/CD20 dual targets, also based on the THANK-u Plus platform.

As of May 11th, among the 12 patients with assessable efficacy, the ORR reached 91.7% and the CR rate was 66.7%. Patients who had previously received CAR-T or bispecific antibody therapy also observed remission. At a median follow-up of 6.62 months, 7 out of 11 responders still maintained remission.

Also releasing data in EHA is CTD402, a allogeneic universal CAR-T targeting CD7 under Beiheng Biotechnology. It is achieved by knocking out TCR and HLA class II molecules and combining with Beiheng's proprietary ANSWER ™ Inhibitory ligands enhance the ability to resist host immune rejection.

Among the 7 patients with R/R T-ALL/LBL, the ORR reached 85.7%, and the overall complete response rate was 71.4%, of which 80% were MRD negative. CAR-T cells reached their peak amplification on the 10th day and persisted in 60% of patients for more than 28 days.

In a study of 15 pediatric and adolescent patients, although 26.7% had primary refractory diseases, 60% had extramedullary lesions, and 60% had high-risk molecular features, CTD402 still showed significant efficacy, with an overall CR rate of 80% and 83.3% of remission patients being MRD negative. 66.7% of patients presented with CRS, mainly mild grades 1-2, and no neurotoxicity or severe infection was observed.

Bangyao Biotechnology announced the latest data on its allogeneic universal CAR-T product BRL-303 for autoimmune diseases at the 2026 ASGCT Annual Meeting.

As of March 2025, four young female patients with refractory systemic lupus erythematosus received treatment, all of whom had a history of multiple organ involvement. The baseline SELENA-SLEDAI score ranged from 14 to 26, and within 3 to 6 months after treatment, all subjects had zero scores and PGA scores<1. Symptoms such as arthritis, hair loss, and finger vasculitis/ulcers completely disappeared, anti double stranded DNA antibody levels decreased, proteinuria disappeared, and both serological and clinical remission were achieved. The infusion process was well tolerated, and no severe infections, ICANS, or GvHD were observed.

At the end of May, Qihan Biotechnology also announced that its self-developed universal dual target CAR-T cell product QT-019B has made significant progress in clinical trials for the treatment of refractory systemic lupus erythematosus (rSLE): it has completed Phase I clinical enrollment and is currently undergoing Phase IIa clinical enrollment.

Preliminary results indicate that QT-019B exhibits similar efficacy characteristics in phase I clinical trials as those initiated by previous researchers (IIT). Especially in SLE patients with severe thrombocytopenia (SLE-ITP), QT-019B showed a rapid and good clinical response, with all such patients achieving complete remission. Based on previous IIT research data, such patients are expected to achieve long-term clinical remission.

 

03、The game and differentiation of technological routes

Since 2017, over 15 autologous CAR-T therapies have been approved for market worldwide, bringing revolutionary breakthroughs to the treatment of hematological malignancies.

However, this type of personalized cell therapy relies on the patient's own T cells, with a production cycle of 2-4 weeks, long waiting times for patients, and high costs. In addition, many late stage patients lose treatment opportunities due to severe immune system damage and a lack of healthy T cells available for CAR-T preparation.

Therefore, how to make such medical breakthroughs a hope within reach of more patients is the direction that the current industry and research community are striving for.

The core idea of allogeneic universal CAR-T is to use T cells from healthy donors for gene editing and modification, and then prepare "off the shelf" products. Compared to autologous CAR-T, it can reduce production costs, shorten patient waiting times, and provide treatment for more patients in a single batch.

In addition, in vivo CAR-T, as a more disruptive "universal" solution, is also receiving high attention from the industry. Since 2025, the total transaction volume of this track has exceeded billions of dollars. CAR-T veteran players Novartis, Gilead BMS、 Johnson&Johnson, followed by AbbVie, AstraZeneca, and Eli Lilly, competed to bet.

Essentially, whether it is the explosion of CAR-T in the body or the reheating of universal CAR-T, they all point in the same direction - to break the accessibility dilemma of autologous CAR-T with simpler production and use processes and lower costs, indicating the industry's determination to evolve towards "spot, accessible, and efficient".

There is a game that is not about life and death, but about different paths leading to the same goal.

The viewpoint of Yang Luhan, founder of Qihan Biotechnology, is very representative: universal CAR-T technology has accumulated relatively long and has a lot of clinical data. In vivo CAR-T has rapidly heated up in the past two years, but the development of the track is still relatively early. Therefore, in simple terms, universal CAR-T is a relatively faster to implement technology route, while in vivo CAR-T is a more long-term disruptive technology, and both will work together to promote cell therapy towards a more accessible future.

Based on this judgment, Qihan Biology adopted a dual strategy parallel approach. In addition to the universal CAR-T products QT-019B and QT-019C, it is also planning to deploy in vivo CAR-T in 2024. Currently, it is promoting five in vivo CAR-T products, covering multiple myeloma, severe autoimmune diseases, non Hodgkin lymphoma, and even solid tumors.

Similarly, there is also Keji Pharmaceutical, which is promoting multiple universal CAR-T models while utilizing its independently developed CARvivo platform to create in vivo CAR-T candidate products targeting CD19/CD20. It is expected to launch an IIT trial for R/R B-NHL in 2026.

In fact, compared to the internal competition between different routes of CAR-T, the industry may be more concerned about the competition brought by the dual antibody drug form to CAR-T in the fields of hematological malignancies and self immunity.

Previously, analysts from Leerink Partners stated in a report that the decline in the growth rate of the autologous CAR-T market is directly related to the rapid rise of bispecific antibody therapy, which has been intensively approved and continues to seize market share in the blood tumor treatment market. This type of therapy does not require personalized manufacturing, is more convenient to use, has a shorter treatment cycle, and is gradually gaining favor among doctors and patients.

In other words, the problem facing the CAR-T field is not which technology route replaces which one, but rather that the entire CAR-T family is being "overtaken" by dual antibodies.
Finally, returning to the question raised at the beginning and discussing the lifecycle of a product, instead of deducing it from the iterative logic of the technical roadmap, it is better to return to a more fundamental dimension: what problems it solves, how much it solves, and how well it solves them.

Technology will iterate and routes will diverge, but the industry's pursuit of 'making it accessible and affordable for patients' will not cool down. The current trend of universal CAR-T is, to some extent, a simple footnote to this pursuit - a technology that can truly solve clinical problems will not be neglected by the market for a long time.

Reference materials:

1 Caribou Biosciences Reports Long-Term Vispa-cel Data in Second-line Large B CellLymphoma at EHA 2026
2.FierceBiotech，Caribou boosts case that off-the-shelf CAR-T matches autologous drugs ahead of phase 3
3. Yimaike, allogeneic universal CAR-T, welcomes the moment of comprehensive validation
4. Science and Technology Innovation Board Daily, Medical News ④: When CAR-T therapy moves towards "universalization"
5. Medical Magic Cube Pro, Interview with Yang Luhan from Qihan Biotechnology: Universal and in vivo CAR-T "Double Swords" Launch, Next Generation Cell Therapy Welcomes Breakthrough Moment
6. Archimedes Biotech, Universal+in vivo, CAR-T Dual King Expected to Launch