Nanobody CD5 CAR‑T for relapsed or refractory CD5‑positive T‑cell cancers

A Multicenter, Open-Label, Non-Randomized, Single-Arm Clinical Study of Nanobody CD5-CAR T Cell Therapy for Refractory/Relapsed T Lymphocyte Malignancies

This will test a CD5-targeted CAR‑T cell treatment using patients' own or donor-derived cells to try to help people with relapsed or refractory CD5+ T‑cell leukemias and lymphomas.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 1 Year to 70 Years
• Sex: All
• Sponsor: Beijing GoBroad Hospital (other)
• Drugs / interventions: CAR T, chemotherapy, CAR-T
• Locations: 4 sites (Beijing, Beijing Municipality and 3 other locations)
• Trial ID: NCT07070323 on ClinicalTrials.gov

What this trial studies

This multicenter, open‑label phase 1/2 study will give CD5-targeted CAR‑T cells to patients (ages 1–70) with CD5+ relapsed or refractory T‑cell malignancies at sites in Beijing and Shanghai. A Bayesian optimal interval (BOIN12) dose‑finding design will explore two planned dose levels across three cohorts (autologous, prior‑transplant donor‑derived, and newly matched donor‑derived products), with a lower fallback dose if manufacturing yield is insufficient. The phase 1 portion focuses on safety, dose‑limiting toxicities within 28 days, and selecting the optimal biological and recommended phase 2 dose, while phase 2 will test anti‑tumor activity. Key operational issues include manufacturing feasibility, adverse event monitoring, and follow‑up for efficacy and safety signals.

Who should consider this trial

Good fit: Ideal candidates are people aged 1–70 with flow cytometry or pathology‑confirmed CD5+ relapsed or refractory T‑cell malignancies who have failed or cannot tolerate standard therapies, have ECOG performance status 0–2, and meet safety and manufacturing criteria.

Not a fit: Patients whose cancer cells do not express CD5, those who have curative standard treatment options available, or patients who are medically unfit for CAR‑T infusion (for example with severe allergy, very short life expectancy, or uncontrolled infection) are unlikely to benefit.

Why it matters

Potential benefit: If successful, this therapy could produce meaningful remissions for patients with CD5+ T‑cell malignancies who have exhausted standard treatment options.

How similar studies have performed: Early‑phase CAR‑T programs targeting CD5 and other T‑cell antigens have shown encouraging responses in small cohorts but remain experimental with limited long‑term outcome data.

Eligibility criteria

Inclusion Criteria:

Only patients who meet all the following criteria can be included:

1\. Candidates with relapse or refractory CD5+ T-cell malignancies, who have progressed after treatment with all standard therapies or been intolerant of standard care, have limited prognosis with currently available therapies and have no available curative treatment options (such as stem-cell transplantation (SCT) or chemotherapy); 2. For subjects who received autologous CD5 CAR T cells, the tumor burden in peripheral blood is less than 20%, and suspending anti-neoplastic treatment for more than 2 weeks; 3. Aged 1-70 years; 4. No severe allergy; 5. Eastern Cooperative Oncology Group (ECOG) performance status 1 score 0 to 2; 6. Patients are expected to live for at least 60 days; 7. CD5+ on blasts in bone marrow (BM) or cerebrospinal fluid (CSF) and tumor tissues by flow cytometry and immunohistochemistry, respectively. (Positive rate \>80% by flow cytometry with less than one log difference in mean fluorescence intensity from normal T cells, or positive rate \>30% positive by immunohistochemistry); 8. Provide a signed informed consent before any screening procedure. Subjects who voluntarily participate in the study should have the ability to understand and sign the informed consent form and be willing to follow the study visit schedule and relevant study procedure, as specified in the protocol. Candidates aged 19-70 years need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form. Children candidates of 8-18 years old need to be sufficiently conscious and able to sign the treatment consent form and voluntary consent form and their legal guardian or patient advocate has also need to sign the treatment consent form and voluntary consent form, respectively. Children candidates of 1-7 can be recruited after the legal guardian or patient advocate has signed the treatment consent form and voluntary consent form; 9. Have available allogeneic hematopoietic stem cell transplantation donor for the subject who received newly matched donor-derived CD5 CAR T cells, and is willing to perform SCT when CR is achieved.

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Exclusion Criteria:

Patients with at least one of the following conditions are excluded:

1\. Impaired consciousness or intracranial hypertension; 2. Symptomatic congestive heart failure or severe cardiac arrhythmia; 3. Manifestations of severe respiratory system failure; 4. Co-existence with other malignancies; 5. Disseminated intravascular coagulation; 6. Serum creatinine and/or blood urea nitrogen (BUN) ≥ 1.5-fold upper limit; 7. Sepsis or other uncontrollable infections; 8. Uncontrollable diabetes; 9. Serious mental illness; 10. Apparent and active intracranial lesions on cranial magnetic resonance imaging (MRI); 11. Underwent organ transplantation, excepting SCT; 12. Pregnant females; 13. Positive test for infectious hepatitis, acquired immune deficiency syndrome (AIDS) or syphilis; 14. Post-CAR SCT is not feasible in patients who plan to receive newly matched donor-derived CD5 CAR T cells; 15. Inability to collect peripheral blood mononuclear cells (PBMC) or no frozen PBMC available for CAR T cell manufacturing.

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Where this trial is running

Beijing, Beijing Municipality and 3 other locations

• Beijing GoBroad Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai — Shanghai, Shanghai Municipality, China (RECRUITING)
• Shanghai Liquan Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
• The General Hospital of Western Theater Command PLA — Chengdu, Sichuan, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Shaocong Miao

Conditions: T-Cell Acute Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, in Relapse, Refractory Acute Lymphoblastic Leukemia, T-cell Malignancies