--- title: International Journal Publication | Team Led by Dr. Kai Hu and Dr. Fan Yang Reports Phase I and Long-Term Follow-Up Data on Low-Dose CD7 CAR-T for Relapsed/Refractory T-Cell Lymphoma url: "https://www.yyhmedical.com/en/news/low-dose-cd7-car-t-t-cell-lymphoma-clinical-study" type: Article inLanguage: en-US category: Medical Advances datePublished: 2026-04-10 --- # International Journal Publication | Team Led by Dr. Kai Hu and Dr. Fan Yang Reports Phase I and Long-Term Follow-Up Data on Low-Dose CD7 CAR-T for Relapsed/Refractory T-Cell Lymphoma > Dr. Kai Hu and Dr. Fan Yang's team published a study in Blood Cancer Journal showing that low-dose CD7 CAR-T maintained high response rates while reducing myelosuppressive toxicity. Summary: Dr. Fan Yang from Dr. Kai Hu's team at Beijing GoBroad Hospital published a study in Blood Cancer Journal reporting Phase I clinical trial data and two-year follow-up results for low-dose CD7 CAR-T cell therapy in 40 patients with relapsed/refractory T-cell lymphoma. The low-dose strategy maintained a high response rate (ORR 92.5%; CR 77.5%) while reducing myelosuppressive toxicity. The study also showed that patients who achieved a response and then proceeded to allogeneic hematopoietic stem cell transplantation (allo-HSCT) had longer survival. The two-year PFS and OS rates were reported as 40.1% and 53.7%, respectively. In recent years, CAR-T cell therapy has become increasingly established in B-cell lymphoma, and clinical research on CD7-targeted CAR-T therapy for relapsed/refractory T-cell lymphoma has also expanded. Early studies have shown high short-term response rates with CD7 CAR-T. At the same time, prolonged post-treatment myelosuppression has been a concern because it can increase the risk of complications such as infection and may prevent some patients from proceeding to allo-HSCT. So how can clinicians preserve the high response rate of CD7 CAR-T while reducing later hematologic toxicity? Recently, Dr. Fan Yang from the Department of Lymphoma and Myeloma at Beijing GoBroad Hospital, working with Dr. Kai Hu's team, published a paper in Blood Cancer Journal titled "Low-dose CD7 chimeric antigen receptor T cells for relapsed/refractory T-cell lymphomas: a single-arm, open-label, phase Ia/Ib study." The paper reports the team's Phase I study and long-term follow-up of low-dose CD7 CAR-T therapy in relapsed/refractory T-cell lymphoma. **Study Background** Dr. Kai Hu explained that relapsed/refractory T-cell lymphoma remains difficult to treat. For many patients, achieving another remission and then proceeding to allo-HSCT is an important route toward longer survival and potential cure. However, these patients are often highly resistant to chemotherapy, may be critically ill, have a high tumor burden, and face complications such as infection. Without an effective way to induce remission, many are not in a condition to undergo allo-HSCT. Preclinical and early clinical studies have demonstrated high initial response rates with CD7 CAR-T, but have also reported prolonged suppression of bone marrow hematopoiesis after treatment. To address this, our team conducted a Phase Ia dose-escalation study followed by a Phase Ib dose-expansion study, lowering the infused dose of CD7 CAR-T cells to explore whether a lower dose could preserve clinical activity while reducing adverse effects. We also report two-year follow-up data from the study. The study enrolled 40 patients with highly complex, refractory disease (median age 32 years; range 18-72). Thirty-five had T-lymphoblastic leukemia/lymphoma and five had mature T-cell lymphoma. Patients had received a median of three prior lines of therapy (range 2-4), and 22 (55%) had previously undergone hematopoietic stem cell transplantation: 17 allo-HSCT and 5 autologous HSCT. Overall, 27.5% had bone marrow blasts above 25%, and 25% had central nervous system involvement. Phase Ia used a 3+3 dose-escalation design with three dose levels: 1 × 10⁴, 5 × 10⁴, and 1 × 10⁵ (±30%) CAR-T cells/kg. No dose-limiting toxicities (DLTs) were observed in the nine Phase Ia patients. In Phase Ib, 31 patients received 1 × 10⁵ (±30%) CAR-T cells/kg as the expansion dose. **Key Findings** **1\. Low-dose CD7 CAR-T showed robust in vivo expansion with manageable adverse events, although cytopenias remained an important concern** CD7 CAR-T cells expanded well in vivo. By flow cytometry (Figure 1A), the median time to peak expansion was day 14 after infusion (range 7-30 days), with a median peripheral-blood count of 82.1 × 10⁶/L (range 0.643-734). CAR transgene copies remained detectable by PCR for up to 396 days (Figure 1B). Among 10 patients with central nervous system involvement, CAR gene copies were detected in the cerebrospinal fluid of 7 patients (Figure 1C). Expansion did not differ significantly according to treatment response or whether the CAR-T cells were autologous or donor-derived. ![ede7d061-8b45-4f82-af29-acd06a47f239.png](https://gaobo-byh-h5.oss-accelerate.aliyuncs.com/images/20260914/26762ecd8a6ed27573fc577a00c8565d_20260914005538.png "26762ecd8a6ed27573fc577a00c8565d_20260914005538.png")Figure 1 Cytokine release syndrome (CRS) occurred in 92.5% of patients, with only two cases of grade 3 CRS. Two patients developed immune effector cell-associated neurotoxicity syndrome (ICANS), one grade 1 and one grade 4. The most common adverse events were hematologic toxicities: grade ≥3 neutropenia occurred in 97.5% (39/40) and grade ≥3 thrombocytopenia in 85% (34/40). In some patients with delayed blood count recovery after donor-derived CD7 CAR-T, infusion of purified donor CD34+ cells successfully supported hematopoietic recovery. Within 30 days, 30% of patients (12/40) developed infections, including 7 grade 3 infections. Among patients who had previously undergone HSCT, acute graft-versus-host disease (aGVHD) occurred in 23.5% (4/17), all grade 1. Chronic GVHD (cGVHD) occurred in 30.8% (4/13), including one case of grade 3 extensive cGVHD. **2\. Low-dose CD7 CAR-T produced high response rates, including in patients with extranodal disease and central nervous system involvement** Across all dose levels, the overall response rate (ORR) was 92.5% (37/40), with a complete response (CR) rate of 77.5% (31/40). In the Phase Ib cohort (n=31), the ORR was 93.5% (29/31) and the CR rate was 80.6% (25/31). All five patients with mature T-cell lymphoma responded: two achieved partial response (PR) and three achieved CR. Among 17 patients who relapsed after HSCT and received donor-derived CAR-T cells, the ORR was 100% (14 CR, 3 PR). Response rates also remained high in patients with extranodal disease (90.6%, 29/32) and those with central nervous system involvement (100%, 6/6). **3\. Bridging to allo-HSCT after remission induced by low-dose CD7 CAR-T was associated with longer survival** With a median follow-up of 30 months (range 14-58 months), median progression-free survival (PFS) and overall survival (OS) among responders were 7.05 months (95% CI: 3.42-NE) and 16.34 months (95% CI: 4.47-NE), respectively. The two-year PFS and OS rates were 40.1% (95% CI: 22.2%-57.5%) and 36.9% (95% CI: 20.0%-53.9%). Among patients who proceeded to allo-HSCT after achieving remission with CD7 CAR-T, the two-year OS rate was 54.1% (95% CI: 26.7%-75.2%), compared with 23.1% (95% CI: 5.6%-47.5%) in those who did not receive allo-HSCT (n=13; P=0.038). Two-year PFS was also 54.1% (95% CI: 26.7%-75.2%) in the allo-HSCT group versus 23.1% (95% CI: 5.6%-47.5%) in the comparison group (P=0.063). Compared with the non-HSCT group, the allo-HSCT group also showed a trend toward a lower two-year cumulative relapse rate (25.5% vs. 64.3%, P=0.149). Among 11 patients who relapsed and underwent repeat assessment of tumor surface antigens, 4 remained CD7-positive, 2 showed low CD7 expression, and 5 had CD7-negative relapse. Antigen escape may therefore be an important mechanism of relapse. ![c839e31d-c5ad-439b-a4b6-4f290825567a.png](https://gaobo-byh-h5.oss-accelerate.aliyuncs.com/images/20260914/4fcd60c9773eadd16f8b4b50d5e7f6ba_20260914005556.png "4fcd60c9773eadd16f8b4b50d5e7f6ba_20260914005556.png")Figure 2 The study suggests that low-dose CD7 CAR-T can produce high response rates in relapsed/refractory T-cell lymphoma with manageable toxicity. For patients who respond, subsequent allo-HSCT may provide an opportunity for improved long-term survival. **Summary and Outlook** Dr. Kai Hu: In relapsed/refractory T-cell lymphoma, a CD7 CAR-T infusion dose of 1 × 10⁵ (±30%) CAR-T cells/kg can produce substantial clinical activity. At the same time, we observed that although short-term response rates are high, consolidation with allo-HSCT after CD7 CAR-T may help reduce relapse and prolong survival. Many questions remain. For example, three patients showed in vivo CD7 CAR-T expansion but did not respond, so the mechanisms of primary CAR-T resistance require further study. The long-term immunologic effects of CD7-targeted depletion on B-cell, T-cell, and NK-cell subsets also remain unclear. In addition, patients with T-cell lymphoma who relapse after allo-HSCT and then receive donor-derived CD7 CAR-T appear to experience more pronounced hematologic toxicity. The optimal supportive-care approach and timing of a possible second transplant in this population require further investigation. The Department of Lymphoma and Myeloma at Beijing GoBroad Hospital has accumulated extensive experience in CAR-T therapy for lymphoma. As real-world use of CAR-T continues to expand, the clinical questions are becoming increasingly complex. Choosing the right timing for CAR-T and developing individualized, precise, full-course management strategies remain major priorities in hematologic oncology. Looking ahead, integrated clinical, pathologic, molecular, and imaging diagnostics may help identify earlier which patients are unlikely to benefit from conventional treatment but may benefit from precision CAR-T strategies. Monitoring approaches such as circulating tumor DNA (ctDNA) may also help detect signs of relapse earlier and create opportunities for earlier intervention, with the goal of extending survival. --- Original (HTML):https://www.yyhmedical.com/en/news/low-dose-cd7-car-t-t-cell-lymphoma-clinical-study This is a clean Markdown mirror for large language models; the original page is authoritative.