CD5 CAR T-cell therapy for relapsed or refractory T-cell malignancies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of CD5 Chimeric Antigen Receptor (CAR) T-cell therapy in patients with relapsed or refractory CD5+ T-cell malignancies. It employs a multi-center, open-label, non-randomized design, utilizing a Bayesian optimal interval (BOIN) approach to determine the optimal biological dose of CAR T-cells. Participants will receive either autologous or donor-derived CD5 CAR T-cells, with the primary objective being to assess dose-limiting toxicities and adverse events within the first 28 days of treatment. The study aims to identify the recommended phase 2 dose based on safety and tolerability outcomes.

Why it matters

Who can join: the full rules

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.

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.

Where it's running

• 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
• Email: miaosc@gobroadhealthcare.com
• Phone: 86+18831006667

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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

  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.

  Recruiting at 3 sites Phase 1/2 Beijing GoBroad Hospital · Beijing, Beijing Municipality and 3 other locations · NCT07070323

• CD7 CAR-T therapy for patients with relapsed or refractory T-cell malignancies

  This study is testing a new type of CAR-T therapy for people with T-cell leukemia that hasn't responded to other treatments to see if it can help them feel better.

  Recruiting at 3 sites Phase 1/2 Beijing GoBroad Hospital · Beijing, Beijing Municipality and 3 other locations · NCT06316427

• ELA026 for adults with relapsed or refractory T-cell and NK-cell cancers

  This Phase 1 trial will test whether ELA026 can help adults with relapsed or refractory T/NK cell cancers who have already received prior therapies.

  Recruiting at 6 sites Phase 1 Electra Therapeutics Inc. · New Haven, Connecticut and 5 other locations · NCT07465835

• CAR T cell therapy for young patients with CD19-positive leukemia

  This study is testing a new treatment combining CAR T cell therapy and chemotherapy to see if it helps young patients with hard-to-treat leukemia.

  Recruiting Phase 2 St. Jude Children's Research Hospital · Memphis, Tennessee · NCT06847269

• Evaluating CAR-T cell therapy with or without stem cell transplantation for relapsed B-cell leukemia

  This study tests if adding a stem cell transplant after CAR-T cell therapy can help young people with relapsed B-cell leukemia live longer and feel better.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality · NCT06581081

• CAR-T cell therapy for adults with relapsed or refractory leukemia and lymphoma

  This study is testing a new CAR-T cell therapy to see if it can help adults with tough-to-treat leukemia or lymphoma feel better and fight their cancer.

  Recruiting at 2 sites Phase 1 Fudan University · Nanchang, Jiangxi and 1 other locations · NCT06445803

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.