Precise Design of Cell Therapy for Relapsed and Refractory Hematological Tumors

NCT06849921 | Active Not Recruiting DMC

• 1 other identifier: ruijinH-KY2024-394
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to evaluate the efficacy and safety of CAR-T cell therapy in patients with relapsed/refractory hematologic malignancies.

Conditions

Precise Design of Cell Therapy for Relapsed and Refractory Hematological Tumors; Hematologic Disease

Keywords

cell therapy; hematological tumors

Outcome Measures

Primary Outcomes (3)

• adverse events.

  Type, incidence and severity of adverse events

  1 month

• Maximum tolerated dose

  The maximum dose that does not cause death of the subject

  1 month

• Overall response rate

  ORR in patients is defined as the rate of complete remission (CR, CRh)

  3 months

Secondary Outcomes (2)

• Overall incidence and severity of adverse events.

  12 months

• Rate of relapse and refractory of Hematologic Diseases patients achieving MRD negative CR

  12 months

Other Outcomes (1)

• Level of circulating CAR T cells

  12 months

Study Arms (1)

Precise Design of CAR-cell Injection

EXPERIMENTAL

The drug for this trial is Precise Designof CAR- cells transduced with the lentiviral vector . The dose is 2x10e6 \~1x10e7 CAR-cell/kg in patients with relapsed/refractory hematologic malignancies.

Drug: Cellular Therapy

Interventions

Cellular Therapy DRUG

This intervention involves the infusion of autologous or allogeneic CAR-T cells into patients with relapsed/refractory hematologic malignancies. CAR-T cells are modified to target specific antigens on the surface of cancerous cells. After the infusion, patients will be monitored for response and safety. Administration: Intravenous infusion. Dosage: The maximum tolerated dose (MTD) will be determined as part of the study, with dose escalation used to identify the optimal and safest dose of CAR-T cells for treatment.

Precise Design of CAR-cell Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with relapsed/refractory hematologic malignancies confirmed to express CD19, CD22, CD20, CD7, CD5, CD2, CD79b, BCMA, GPCR5D, CD38, CD33, CD123, CD133, CLL1, EBV (GP350, LMP1), CMV (Gb21, gB280…) or other validated targets (supported by domestic and international preclinical/clinical evidence) who meet the following criteria:
• Male or female, aged ≥18 years and \<75 years; Newly diagnosed patients with refractory disease (as defined by respective diagnostic criteria) after chemotherapy; Newly diagnosed patients with disease progression during chemotherapy and poor anticipated response to further chemotherapy; Patients with relapsed disease (≥1 recurrence) and confirmed residual tumor evidence; Patients with relapse after autologous or allogeneic hematopoietic stem cell transplantation (HSCT); Patients with relapse after CAR-T therapy; Patients with hematologic malignancies deemed incurable by current surgical, radiotherapy, or chemotherapy interventions.

You may not qualify if:

• Patients meeting any of the following criteria will be excluded:
• Life expectancy \<12 weeks; Genetic testing reveals mutations or structural variants associated with the target antigens; Severe graft-versus-host disease (GVHD) requiring immunosuppressive therapy in post-HSCT relapse patients; Post-HSCT relapse \<3 months with no available donor;
• Organ dysfunction:

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200020, China

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Hematologic Diseases

Interventions

Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: February 27, 2025
• Study Start: November 7, 2024
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: February 27, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)