CAR-T cell therapy for relapsed or treatment-resistant blood cancers

The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies

This trial will test whether an autologous CAR-T cell infusion is safe and tolerable for people ages 14–75 with relapsed or refractory leukemia, lymphoma, or multiple myeloma whose tumors express CD19, CD20, or BCMA.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 14 Years to 75 Years
• Sex: All
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T
• Locations: 1 site (Taiyuan, Shanxi)
• Trial ID: NCT05618041 on ClinicalTrials.gov

What this trial studies

This interventional protocol uses patients' own T cells engineered to express chimeric antigen receptors (CARs) targeting CD19, CD20, or BCMA and delivers the product by infusion. The primary aim is to test tolerability and safety in people with relapsed or refractory hematologic malignancies, with secondary analyses of CAR-T pharmacodynamics and immune behavior across disease types. Participants undergo leukapheresis for cell collection, manufacturing of autologous CAR-T, possible lymphodepleting preconditioning, and in-hospital monitoring for expected toxicities such as cytokine release syndrome and neurotoxicity. Clinical and laboratory follow-up will track organ function, tumor response markers, and CAR-T cell kinetics.

Who should consider this trial

Good fit: Ideal candidates are people aged 14–75 with relapsed or refractory lymphoma, leukemia, or myeloma who have tumors expressing the target antigens (CD19, CD20, or BCMA), an ECOG score ≤2, and adequate organ function.

Not a fit: Patients whose tumors lack the target antigens, who have inadequate organ function, active uncontrolled infections, or who fall outside the 14–75 age range may not benefit from this therapy.

Why it matters

Potential benefit: If successful, this approach could offer a new personalized treatment option using patients' own immune cells to target and reduce relapsed or refractory blood cancers.

How similar studies have performed: Similar CAR-T approaches targeting CD19 and BCMA have produced effective, approved therapies in other trials, although this specific product and regimen may be novel.

Eligibility criteria

Inclusion Criteria:

* Sign the informed consent and be willing and able to comply with the visit, treatment protocol, laboratory examination, and other requirements of the study as specified in the study procedure sheet;
* Diagnosed as recurrent or refractory lymphoma, leukemia or myeloma;
* Tumor cells express targets for CAR-T cell therapy (results: flow cytometry or Immunohistochemical test confirmation);
* Age 14-75 (including threshold), gender unlimited;
* Eastern Cooperative Oncology Group (ECOG) score ≤2;
* HGB ≥ 70g/L (blood transfusion allowed);
* Liver and kidney functions, heart and lung functions meet the following requirements:

  1. Creatinine ≤ 1.5 × ULN;
  2. Left ventricular ejection fraction ≥ 50%;
  3. Blood oxygen saturation\>90%;
  4. Total bilirubin ≤ 1.5 × ULN； ALT and AST ≤ 2.5 × ULN;
* For T cell tumor patients, if tumor cells are detected in peripheral blood during screening, flow cytometry should be used to detect that the tumor cell surface immunophenotype is CD4 and CD8 double negative. If the immunophenotype of peripheral blood tumor cells is not double negative for CD4 and CD8, the condition that the proportion of peripheral blood tumor cells is ≤ 1% shall be met;
* Subjects with pregnancy plans must agree to use contraception before entering the study and after the study lasts for six months; If the subject is pregnant or suspected of being pregnant, the investigator shall be informed immediately;
* The subject or guardian understands and signs the informed consent form;
* Expected survival longer than 3 months.

Exclusion Criteria:

* Severe cardiac insufficiency;
* Have a history of severe lung impairment;
* Complicated with other advanced malignant tumors;
* Complicated with severe or persistent infection that cannot be effectively controlled;
* Complicated with severe autoimmune diseases or congenital immune deficiency;
* Active hepatitis (HBV DNA or HCV RNA positive);
* Human immunodeficiency virus (HIV) infection or syphilis infection;
* Have a history of severe allergy to biological products (including antibiotics);
* If there is a history of hematopoietic stem cell transplantation, it should be no more than 6 months before the patient receives allogeneic hematopoietic stem cell transplantation;
* Subjects who received CAR-T therapy or other gene modified cell therapy before screening;
* Conditions that the investigator believes may increase the risk to the subject or interfere with the outcome of the study.

Where this trial is running

Taiyuan, Shanxi

• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Recruiting)

Study contacts

• Study coordinator: Weiwei w Tian, MD

Conditions Acute Lymphoblastic Leukemia; Lymphoma; Multiple Myeloma; CD19,CD20,BCMA; B-ALL/MM/NHL