Status:
NOT_YET_RECRUITING
Allogeneic Immunotherapy of Hematological Malignancies Using Regulatory T-cell Selective Depletion
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Hematological Malignancies
Regulatory T Cell Depletion
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Since the discovery that Treg suppress anti-tumor immune responses, inhibiting their function has become a major challenge for the development of efficient immunotherapy for cancer. In humans, we prev...
Eligibility Criteria
Inclusion
- Adult patient (older than 18 years old without upper limit of age) diagnosed with leukemia, myelodysplasia, myeloproliferative disorder or lymphoproliferative disorder (CLL, myeloma, lymphoma)
- Previous allogeneic HSCT from a matched sibling, haplo-identical or unrelated donor (any type of conditioning regimen)
- Haematological relapse (molecular, cytogenetic or cytological) after HSCT
- Patient refractory (no or partial response) to one or several previous standard unmanipulated DLI
- Availability of cryopreserved lymphapheresis
- No loss of chance by using of DLI rather than more incisive anti-tumor agents according to investigator appreciation
- Written informed consent before any intervention necessary for the trial
- Affiliation to a social security regime
- Negative pregnancy test for women of childbearing age participating in the study
- Effective contraceptive methods for men / women in line with the current CTFG recommendations version 1.1
Exclusion
- Acute grade ≥ II or moderate/severe chronic GVHD at the time of inclusion
- Patient receiving immunosuppressive treatment for GVHD or any other reason
- Creatinine clearance\< 50 ml/min
- Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) \> 5.0 x upper limit of normal (ULN)
- Serum total bilirubin \> 50µM (expect for unconjugated hyperbilirubinemia due to Gilbert's disease)
- Performance status ECOG\>1
- Severe infection according to CTCAE grading (grade\>2)
- Pregnant or lactating women
- Patient under tutorship, curatorship or legal protection
- Ongoing participation in another interventional research protocol within the same field of immune modulation (through cell therapy or not)
- State medical aid
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06180499
Start Date
March 1 2024
End Date
September 1 2029
Last Update
February 14 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.