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Trial Title:
Anti-GPRC5D CAR-T Cells (CT071) in Participants With RRMM or RRpPCL
NCT ID:
NCT06333509
Condition:
Multiple Myeloma
Primary Plasma Cell Leukemia
Conditions: Official terms:
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Leukemia, Plasma Cell
Conditions: Keywords:
CAR-T
Multiple Myeloma
Primary plasma cell myeloma
CT071
GPRC5D
anti-GPRC5D
genetically modified T-cells
hematologic cancer
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention model description:
Phase 1; Dose escalation followed by dose expansion Phase 2; Single group of each
indication will be dosed at the recommended dose level from Phase 1.
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
N/Ap
Intervention:
Intervention type:
Biological
Intervention name:
CT071
Description:
a single CAR-T infusion of CT071
Arm group label:
Phase 1
Arm group label:
Phase 2
Summary:
A Phase 1/2 Open label, multicenter, clinical trial of autologous CAR T-cell therapy
targeting GPRC5D, in participants with relapsed/refractory multiple myeloma or
relapsed/refractory primary plasma cell leukemia.
Detailed description:
This is an open-label, multicenter, Phase 1/2 trial of CT071 in adult participants with
relapsed or refractory multiple myeloma (RRMM) or relapsed or refractory primary plasma
cell leukemia (RRpPCL).
The study will be conducted in two phases. Phase 1 of the study will be dose escalation
followed by dose expansion. After recommended Phase 2 dose is identified in Phase 1, the
enrollment of Phase 2 will start. Following consent, enrolled subjects will undergo
apheresis to collect cells for manufacture of the CAR-T cells. Following the manufacture
of the CAR-T cells, subjects will receive lymphodepletion prior to CAR T-cell infusion.
All subjects who complete the study, as well as those who withdraw from the study after
receiving CAR T-cell infusion for reasons other than death or meeting the early
termination criteria, will be asked to undergo a 15-year long-term follow-up.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Voluntarily signed consent;
- Age of ≥ 18;
- Willing and able to adhere to trial visit schedule and other protocol requirements
- Received sufficient prior lines of therapy;
- RRMM participants must have received treatment with at least one proteasome
inhibitor, one IMiD and CD38 anti body, must be refractory to the last line of
therapy, must have achieved a response (PR or better) to a least 1 prior treatment
line;
- RRpPCL participants must have received at least one prior line of therapy.
- Participants must have documented diagnosis of RRMM or RRpPCL.
- The participants should have measurable disease.
- Estimated life expectancy > 12 weeks;
- ECOG performance score 0-1;
- Participants should have bone marrow reserve, renal and hepatic functions;
- Sufficient venous access for apheresis collection, and no other contraindications to
apheresis;
- Must be able to stop any anticancer therapy for planned apheresis collection
- Women of childbearing age must undergo a serum pregnancy test with negative results
before screening, and are willing to use effective and reliable method of
contraception for at least 12 months after T cell infusion;
- Men must be willing to use effective and reliable method of contraception for at
least 12 months after T cell infusion.
Exclusion Criteria:
- Any significant condition(s), laboratory abnormality or psychiatric illness that
would impair the ability of the participant to receive or tolerate the planned
treatment or in the opinion of the investigator, participation would not be in the
best interest of the participant (eg, compromise the well-being) or that could
prevent, limit, or confound the protocol-specified assessments.
- Pregnant or lactating women;
- HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection;
- Any uncontrolled active infection;
- AEs from previous treatment that have not recovered;
- Participants who have had anti-GPRC5D targeted agents;
- Participants who have received autologous stem cell transplantation 12 weeks before
apheresis;
- Participants who have received allogenic stem cell transplantation within 6 months
of apheresis;
- Participants who have graft versus host disease (GvHD);
- Participants who have received steroids within 14 days of apheresis or
lymphodepletion;
- Participants who have plasma cell leukemia secondary to multiple myeloma,
Waldenström macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy,
monoclonal gammopathy, and skin changes) syndrome or clinically significant
symptomatic immunoglobulin light chain (AL) amyloidosis with evidence of end-organ
damage;
- Participants who have been administered live attenuated vaccine 4 weeks before
apheresis or lymphodepletion;
- Participants who are allergic to fludarabine, cyclophosphamide, tocilizumab,
dimethyl sulfoxide (DMSO) or CT071;
- Participants who have clinical significant cardiac conditions that researchers
believe that participating in this clinical trial may endanger the health of the
patients;
- Participants who require supplemental oxygen;
- Participants who have clinically significant pulmonary conditions;
- Participants who are known to have active autoimmune diseases including but not
limited to psoriasis, rheumatoid arthritis and other needs of long-term
immunosuppressive therapy;
- Participants with malignancies in addition to MM/pPCL;
- Participants who have central nervous system (CNS) metastases or CNS involvement;
- Participants with a history of stroke or seizures within 6 months prior to
apheresis;
- Participants who have undergone major surgery 14 days prior to apheresis or within
28 days of CT071 administration.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 15, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
CARsgen Therapeutics Co., Ltd.
Agency class:
Industry
Source:
CARsgen Therapeutics Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06333509