Clinical Study of CAR-T Cell Therapy Following ASCT for R/R B-cell Non-Hodgkin's Lymphoma

Lymphoma, B-Cell Clinical Trial

Official title:

Clinical Study of the Efficacy and Safety of Chimeric Antigen Receptor T-cell Therapy Following Autologous Stem Cell Transplantation for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06381830
• Other study ID #: ASCT+CART
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: March 2024
• Source: The First Affiliated Hospital of Soochow University
• Contact: Caixia Li, M.D.
• Phone: +86 512 67781856
• Email: licaixia[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is designed to evaluate the efficacy and safety of chimeric antigen receptor T-cell therapy following autologous stem cell transplantation for relapsed/refractory B-cell Non-Hodgkin's lymphoma.

Description:

Chimeric antigen receptor T (CAR-T) cell therapy has emerged as a promising approach for relapsed or refractory B-cell Non-Hodgkin's lymphoma (R/R B-NHL), with a complete response (CR) rate of about 50%. It is also considered to be a reasonable consolidation option in low or unmeasurable disease states recently. Unfortunately, 40%-70% of patients experienced relapse after CAR-T cell therapy in the long-term follow up. Autologous stem cell transplantation (ASCT) with myeloablative chemotherapy can enhance the efficiency of CAR-T cells and alleviate tumor load, leading to a lower relapse rate. As a result, CAR-T cell therapy following ASCT may be a promising method for R/R LBCL patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age: 18-65 years.

2. Pathological immunohistochemistry or flow cytometry confirmed that R/ R Large B-cell Non-Hodgkin's Lymphoma with measurable (the longest diameter greater than 1.5cm and the longest vertical diameter greater than 1.0cm) lesions.

3. Previously treated with 1 or more lines of therapy.

4. ECOG=2#.

5. The main organ functions need to meet the following conditions:LVEF=50%;CCr=30 ml/min; ALT and AST=3 times normal range.

6. Hematopoietic function needs to meet the following conditions: platelet count=45×10^9/L; hemoglobin=8.0 g/dL; absolute neutrophil count=1.0×10^9/L.

7. Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up one year period of the study.

8. Estimated survival time =3 months.

9. Voluntary signing of informed consent and good compliance.

Exclusion Criteria:

1. Have used immunosuppressants or hormones within 2 weeks prior to apheresis, or have to use immunosuppressants or hormones after signing informed consent.

2. The presence of bacterial, fungal, viral, mycoplasma or other types of infection that, in the judgment of the investigator, are difficult to control.

3. Active hepatitis B or active hepatitis C.

4. HIV infection.

5. Have received CAR-T cell therapy or allogeneic hematopoietic stem cell transplantation prior to signing the informed consent.

6. Prior malignancy (other than Relapsed Refractory B-cell Non-Hodgkin's Lymphoma).

7. Pregnant or breasting-feeding women.

8. There is evidence of complications or medical conditions that could interfere with the conduct of the study or put patients at serious risk, including but not limited to serious cardiovascular disease.

9. Conditions deemed by the researchers to be inappropriate for participation.

Related Conditions & MeSH terms

• Autologous Stem Cell Transplantation
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Intervention

Other:
• Apheresis
Participants will undergo two separate apheresis procedures, including: G-CSF primed hematopoietic stem cell collection and peripheral blood mononuclear cell apheresis for CAR-T cell manufacturing.
• Autologous Stem Cell Transplantation
Participants are designed to receive myeloablative conditioning regimen prior to infusion of a minimum 2 x 10^6 CD34+ stem cells/kilogram.

Drug:
• CAR-T Cell Therapy
CAR-T cells will be infused within 7 days after autologous hematopoietic stem cell infusion (2-10×10^6 CAR-T/kg,ivgtt).

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (3)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University	Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd, Suzhou Hongci Hematology Hospital, Suzhou, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	Number of participants who will have achieved response after ASCT plus CAR-T cell Therapy.	Up to 24 months
Primary	Progression-free Survival(PFS)	PFS is defined as the time from ASCT to progression, death or the last follow-up point	Up to 24 months
Secondary	Duration of Response(DOR)	To measure the duration of response to ASCT Plus CAR-T Cell Therapy over a follow-up period of 24 months	Up to 24 months
Secondary	Complete Response Rate	Number of participants who will have achieved complete response after ASCT plus CAR-T cell Therapy.	Up to 24 months
Secondary	Overall Survival(OS)	OS will be assessed from ASCT plus CAR-T cell therapy to death or last follow-up.	Up to 24 months
Secondary	Adverse events profile	Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated.	Up to 24 months