CTD-402 / Nanjing Bioheng Biotech - LARVOL DELTA

A single-arm, open-label, multi-center, phase 1b/2 Study to evaluate the safety, efficacy, and cellular pharmacokinetic profile of CTD402 in participants with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) and lymphoblastic lymphoma (T-LBL) (TENACITY-01) (ASH 2025) - P=N/A, P1, P1/2, P2 | "Prior to the infusion ofCTD402, participants will undergo standard lymphodepletion consisting of fludarabine (30mg/m2 x 3days) and cyclophosphamide (500mg/m2 x 3 days) on days -5 to Day -2 with a 2-day rest period beforeinfusion of CTD402 on Day 0.In the Phase 1b portion of the study, the dose of CTD402 may be escalated to 800 x 106 cells or de-escalated to a dose of 200 x 106 cells based on review of safety data by the Safety Review Committee.Key eligibility criteria include participants age 12 and older diagnosed with R/R T-ALL/LBL, defined as thepresence of 5% bone marrow blasts or evidence of extramedullary disease, with one of the following: R/Rdisease after ≥ 2 lines of systemic therapy, first relapse ≤ 12 months of first remission, or any relapseafter HSCT. Keysecondary and exploratory objectives include MRD negativity and percentage of patients undergoingHSCT while in remission. Safety and response data will be evaluated by an independent..."

Clinical • P1/2 data • PK/PD data • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Lymphoblastic Lymphoma • Lymphoma • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • FCGR2A • FCGR2B • HEY1 • IL2RG

CTD402, allogeneic anti-CD7 CAR t-cell, in relapsed or refractory (R/R) t-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL) - report of clinical outcomes at the recommended phase 2 dose (RP2D) (ASH 2025) - P=N/A, P1, P2 | "Hereinwe present the data of a cohort of these pts treated at the RP2D.MethodsThe RP2D of CTD402 is 400 million (M) cells administered on day (D) 0 following standardlymphodepleting chemotherapy (sLD)consisting of fludarabine (30 mg/m²/day) and cyclophosphamide(500 mg/m²/day) from days -5 to -3; this is the starting dosing regimen on the ongoing global clinical study(NCT# 07070219).ResultsUp to a data cutoff June 30th, 2025, 41 R/R T-ALL/LBL (27 ALL, 13 LBL, 1 MPAL) pts, median age 27 years(range 10-56), were treated at the RP2D. This program advances an "off-the-shelf" ready atpoint of care CAR-T cell therapy in heavily pre-treated patients with R/R T-ALL/LBL. A global Phase 1b/2study is ongoing and currently enrolling patients (NCT# 07070219)."

CAR T-Cell Therapy • Clinical • Clinical data • P2 data • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Lymphoblastic Lymphoma • Lymphoma • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • CD7 • IFNG • NOTCH1

CD7-targeted universal CAR T-cell therapy in relapsed or refractory (R/R) acute myeloid leukemia (AML): Clinical results from CTD401/402 studies (ASH 2025) - P1, P2 | "(NCT04538599, NCT05902845,NCT05895994, NCT05454241) In these investigator-initiated trials, eligible CD7+ R/R AML patients received lymphodepletionwith fludarabine (25-30mg/m2) and cyclophosphamide (400-850mg/m2) for 3-5 days, with/withoutetoposide (100mg/m2) for 3 or 5 days...One developed Grade 2ICANS after CTD402 redosing due to absent expansion following initial infusion... CTD401/402 were well tolerated up to 1×10⁹ CAR⁺ T cells with no DLTs. Among patients withhigh CD7 expression, best overall response rate reached 62.5%, supporting CD7 as a viable target in amolecularly defined AML subset. Subsequent HSCT/HCB may be crucial for sustaining remission afterCAR T-cell therapy, and in selected AML patients, CD7-directed CAR T cells may allow foregoing/reductionof myeloablation, enabling potentially curative transplantation with reduced toxicity as we havepreviously published (NEJM 2024)."

CAR T-Cell Therapy • Clinical • IO biomarker • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Leukopenia • Neutropenia • Thrombocytopenia • CD123 • CD33 • CD7 • IL3RA

A Phase I, open-label study of CTD402, a universal CD7-targeting CAR T-cell therapy, in patients with relapsed/refractory severe aplastic anemia (ASH 2025) - P1 | "The standard of care for patients ineligiblefor or without a matched sibling donor for hematopoietic stem cell transplantation (HSCT) isimmunosuppressive therapy (IST) with anti-thymocyte globulin (ATG), cyclosporine (CsA), and a TPO-receptor agonist (TPO-RA)...Key exclusion criteria include pancytopenia from other causes (e.g.,hypoplastic MDS), prior allogeneic HSCT or CAR T-cell therapy, significant cardiovascular, hepatic or renaldysfunction, and active, uncontrolled infections.Study Treatment: Eligible patients will receive a standard lymphodepletion (sLD) regimen of fludarabine(25 mg/m²/day) and cyclophosphamide (500 mg/m²/day) for 3 days...Keysecondary endpoints include the overall hematologic response rate (ORR) at 3 and 6 months, duration ofresponse, and the PK profile of RD13-02. Exploratory endpoints include the analysis of biomarkersrelated to immune reconstitution and disease activity.The study is currently recruiting patients."

CAR T-Cell Therapy • Clinical • IO biomarker • Anemia • Aplastic Anemia • Bone Marrow Transplantation • Cardiovascular • Hematological Malignancies • Infectious Disease • Liver Failure • Nephrology • Renal Disease • CD7

CTD402: Allogeneic CAR-t manufacturing that overcomes donor- & process-derived variation with robust clinical activity (ASH 2025) - "This comprehensive analysis demonstrates the clinical response and consistency of CTD402allogeneic CAR-T cells manufactured from different donors. The observed robust responses highlight thetherapeutic potential of allogeneic CAR-T products, compared to their autologous counterparts and manyother treatment modalities. The development experience with the CTD402 program offers valuableinsights for the broader allogeneic CAR-T field."

Clinical • IO biomarker • Cognitive Disorders • Graft versus Host Disease • Hematological Malignancies • Immunology • T Acute Lymphoblastic Leukemia • CD4 • CD7 • CD8 • IFNG

The final CTD402 poster (Abstract #4180) demonstrated that Imviva’s standardized manufacturing process effectively mitigates donor and lot variability while delivering consistent clinical outcomes. (GlobeNewswire) - "Analysis of 18 production lots from 13 donors and 64 patients with R/R T-ALL/LBL showed robust product quality and pharmacokinetics across three optimized process stages, with low intradonor variability, and robust efficacy across all processes and donors. These findings underscore CTD402’s potential as a scalable CAR-T solution that combines manufacturing reliability with strong clinical performance, offering a cost-efficient alternative to autologous CAR-T therapies."

Clinical • Acute Lymphocytic Leukemia • T-cell Acute Lymphoblastic Lymphoma

The second CTD402 poster (Abstract #3210) details how the therapy can be used to treat SAA, a life-threatening bone marrow failure disorder driven by aberrant T-cell activity, with limited treatment options for patients unresponsive to immunosuppressive therapy. (GlobeNewswire) - "The ongoing Phase I trial (NCT06622694) uses a single-arm, open-label, 3+3 dose-escalation design to evaluate safety, tolerability, and determine the maximum tolerated dose in adults with R/R SAA. Secondary objectives include hematologic response rates at 3 and 6 months, duration of response, and pharmacokinetics, with exploratory endpoints assessing immune reconstitution biomarkers. Patients receive standard lymphodepletion followed by CTD402 infusion."

Clinical protocol • Aplastic Anemia

The first poster (Abstract #5954) highlighted the promising ‘off-the-shelf' CAR-T approach of CTD402, being evaluated in the Phase 1b/2 TENACITY-01 clinical trial (NCT07070219) for the treatment of R/R T-ALL and LBL. (GlobeNewswire) - "The ongoing global, single-arm, open-label trial is enrolling adolescents and adults (≥12 years) to evaluate safety, efficacy, and cellular pharmacokinetics. Phase 1b will determine the recommended Phase 2 dose in ~18 patients, followed by Phase 2 enrollment of ~36 patients. All participants receive standard dose lymphodepletion (fludarabine/cyclophosphamide) and a flat dose of 400×10⁶ CTD402 CAR-T cells. Primary endpoints include incidence of dose-limiting toxicities and overall complete remission rate, while secondary endpoints assess pharmacokinetics."

Clinical protocol • Acute Lymphocytic Leukemia • T-cell Acute Lymphoblastic Lymphoma

Imviva Biotech Presents Clinical Breakthroughs for CTD402 in High-Mortality T-Cell and Myeloid Leukemias at the 67th American Society of Hematology Annual Meeting (GlobeNewswire) - "The first presentation (Abstract #816), showcased CTD402's activity in relapsed/refractory acute myeloid leukemia (R/R AML)....A total of 10 R/R AML patients were dosed with CTD402; in Eight CD7 high (>80% expression) R/R AML patients were treated with CTD402; in those patients response rate was 62.5%....In the second oral presentation (Abstract #1042) demonstrated robust clinical efficacy at the recommended Phase 2 dose in patients with relapsed/refractory T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma (T-ALL/LBL). Among 39 evaluable patients, CTD402 achieved a complete remission rate of 64.1%, with 91.7% of responders achieving disease-negative status."

Clinical data • Acute Myelogenous Leukemia • Lymphoblastic Lymphoma • T-cell Acute Lymphoblastic Lymphoma

Imviva Biotech Announces Seven Presentations Highlighting its ANSWER Allogeneic CAR-T Platform at the 67th American Society of Hematology Annual Meeting (GlobeNewswire) - "The company will present the latest clinical data for CTD402, its investigational CD7 allogeneic CAR-T cell therapy, and CTA311, a universal anti-CD19 CAR-T cell therapy in development for patients with T-ALL/LBL, AML, B-ALL and severe aplastic anemia, and relapsed/ refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL), respectively. An oral presentation on CTD402 in relapsed/refractory T-ALL/LBL has been selected as a conference highlight..."

Clinical data • Acute Myelogenous Leukemia • Aplastic Anemia • B Acute Lymphoblastic Leukemia • Lymphoblastic Lymphoma • T-cell Acute Lymphoblastic Lymphoma

Neither Conditioning Chemotherapy Nor GvHD-Prophylaxis: CD7 CAR-T Treatment Bridging to Haplo-HSCT (ASH 2023) - P1 | "All patients received allogeneic CD7 CAR-T therapy, manufactured from either haploidentical donors (n=8) in a phase I clinical trial of donor-derived CAR-T cells (NCT04599556) or (n=1) universal CD7 CAR-T cells (RD13-02) therapy (NCT05716113) or as a compassionate use program after the end of a phase I clinical trial of universal CD7 CAR-T cells (RD13-01) (NCT04538599)...3 patients experienced short-term grade II acute GvHD, which was resolved completely after low dose steroid, anti-TNF-α or ruxolitinib therapy... Our findings demonstrate a novel strategy to simultaneously achieve CAR-T persistence and complete HSC engraftment, while reducing the risks of GvHD, providing valuable insights into combining cellular therapy with allo-HSCT for the treatment of R/R acute leukemia patients ineligible for conventional allo-HSCT."

Acute Graft versus Host Disease • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Oncology • Palliative care • Septic Shock • CD7

A Novel Generation of Anti-CD7 Universal CAR-T Therapy for Patients with Relapsed or Refractory CD7 Positive T-ALL/Lbl: A Phase I Clinical Trial (ASH 2024) - P1 | "These modified cells are designated as RD13-02...All pts received a standard lymphodepletion regimen consisting of fludarabine (30mg/m2/day) and cyclophosphamide (500mg/m2/day) for three consecutive days (day -5 to day -3) before CAR-T infusion (day 0)...Notably, 100% of CR/CRi pts achieved MRD-negative status, offering pts more prompt treatment options. Dose expansion is ongoing at DL1, and additional clinical and correlative analyses will be presented at the meeting."

Clinical • P1 data • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • CD7 • CD8

TENACITY-01: A Study of CTD402 in T-ALL/LBL Patients (clinicaltrials.gov) - P1/2 | N=54 | Recruiting | Sponsor: BIOHENG THERAPEUTICS US LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma

New Concepts and Future Perspectives of CD7 CAR T-cell Therapy for Hematologic Malignancy (ICBMT 2025) - "In this presentation, will focus on a Universal (U) CD7 CAR-T (CTD402) for treating refractory and relapsed (R/R) T-ALL/LBL (multi-center IIT clinical trials) and autologous CD7CAR-T for R-TALL/LBL (phase I/II clinical trial) followed by allo-HSCT...Our previous studies have demonstrated that NS7CAR-T therapy is effective in treating R/R T-ALL/LBL patients with promising long-term outcomes while maintaining a manageable safety profile...Patients aged ~14 in the CD7 CAR-T group achieved high 2-year OS and LFS rates of 87.5%. Our study indicates that CD7 CAR-T therapy followed by allo-HSCT is not only effective and safe for r/r T-ALL/LBL patients but also on par with the outcomes of those achieving CR through chemotherapy, without increasing NRM."

CAR T-Cell Therapy • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • CD7

CD7 CAR T Cells (RD13-02) in the Treatment of Relapsed/Refractory Severe Aplastic Anemia (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Institute of Hematology & Blood Diseases Hospital, China | Initiation date: Oct 2024 ➔ Jun 2025 | Not yet recruiting ➔ Recruiting

Enrollment open • Trial initiation date • Anemia • Aplastic Anemia

A Study on the Safety, Preliminary Efficacy, and Cellular Kinetics of Allo-CD7 CAR-T Cells in T1DM (clinicaltrials.gov) - P1 | N=3 | Active, not recruiting | Sponsor: Nanjing Bioheng Biotech Co., Ltd.

New P1 trial • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

FDA…granted Rare Pediatric Disease Designation (RPDD) to its investigational allogeneic CAR‑T cell product, CTD402, for the treatment of relapsed/refractory T‑cell acute lymphoblastic leukemia (R/R T‑ALL) and lymphoblastic lymphoma (R/R LBL) (flcube.com)

FDA event • Lymphoblastic Lymphoma • T Acute Lymphoblastic Leukemia

TENACITY-01: A Study of CTD402 in T-ALL/LBL Patients (clinicaltrials.gov) - P1/2 | N=54 | Not yet recruiting | Sponsor: BIOHENG THERAPEUTICS US LLC

New P1/2 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma

CTD402: A UNIVERSAL ANTI-CD7 CHIMERIC ANTIGEN RECEPTOR T-CELL THERAPY FOR PATIENTS WITH RELAPSED OR REFRACTORY (R/R) T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA/LYMPHOBLASTIC LYMPHOMA (T-ALL/LBL) (EHA 2025) - P=N/A, P1, P2 | "Most pts received a standardized lymphodepletion (sLD) regimen consisting of fludarabine (30 mg/m²/day) and cyclophosphamide (500 mg/m²/day) from days -5 to -3 prior to CTD402 infusion.From 12/2021-11/2023, 62 R/R T-ALL/LBL (46 ALL, 16 LBL) pts, median age 23 years (range 4-61), were enrolled and treated. Data presented feature CTD402 as a potent, well-tolerated UCAR-T therapy, delivering high MRD negative remission rates, and lasting benefits—especially when paired with allo-HSCT. A global study, to be launched this year, is in preparation."

CAR T-Cell Therapy • Clinical • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma

Bioheng Therapeutics Announces FDA Clearance of IND Application for CD7 UCAR T Cell Therapy in T-ALL/LBL (PRNewswire) - "Bioheng Therapeutics US LLC...announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for CTD402, a CD7-targeted universal CAR-T (UCAR-T) cell therapy, for the treatment of pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL). The study approved by the FDA is a single-arm, open-label Phase Ib/II trial with a simplified dose-finding design, designed to optimize dosing and accelerate clinical development."

IND • New P1/2 trial • Childhood T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma

Bioheng Therapeutics Announces FDA Clearance of IND Application for CD7 UCAR T Cell Therapy in T-ALL/LBL (PRNewswire) - "Bioheng Therapeutics US LLC...announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for CTD402, a CD7-targeted universal CAR-T (UCAR-T) cell therapy, for the treatment of pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL). The study approved by the FDA is a single-arm, open-label Phase Ib/II trial with a simplified dose-finding design, designed to optimize dosing and accelerate clinical development."

IND • New P1/2 trial • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma

RD13-02: CD7 CAR-T for Patients With r/r CD7+ Hematologic Malignancies (clinicaltrials.gov) - P2 | N=14 | Completed | Sponsor: Institute of Hematology & Blood Diseases Hospital, China | Recruiting ➔ Completed | N=22 ➔ 14 | Trial completion date: Sep 2025 ➔ Aug 2024

Enrollment change • Trial completion • Trial completion date • Hematological Disorders • Hematological Malignancies • Oncology • CD7

RD13-02 Cell Injection in Patients with Relapsed or Refractory CD7-Positive Natural Killer/T Cell Malignancies (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Wuhan Union Hospital, China

New P1 trial • Hematological Disorders • Hematological Malignancies • Lymphoma • Natural Killer/T-cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

RD13-02 for Patients With r/r CD7+ T Cell Hematologic Malignancies (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Henan Cancer Hospital | Recruiting ➔ Completed | N=10 ➔ 6 | Trial completion date: Jun 2026 ➔ Aug 2024 | Trial primary completion date: Jun 2025 ➔ Aug 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Oncology • CD7

BHCT-RD13-02-02: CD7 CAR-T for Patients With r/r CD7+ T-ALL/T-LBL (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: He Huang | Recruiting ➔ Completed | Trial completion date: May 2025 ➔ Aug 2024 | Trial primary completion date: Mar 2024 ➔ Aug 2024

CAR T-Cell Therapy • Trial completion • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • CD7