Relapsed and/or Refractory Multiple MyelomaNCT05893693
Assess the Safety and Efficacy of CT0594CP Cells in Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia
A study testing Biological in people with Relapsed and/or Refractory Multiple Myeloma and Plasma Cell Leukemia in Relapse, run by Aibin Liang，MD，Ph.D. at 1 site in China.
Trial summary
This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT0594CP CAR-T Cells in patients with relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed and/or Refractory Multiple Myeloma, Plasma Cell Leukemia in Relapse
- What is being tested?
- Biological
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2023to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients and legally acceptable representative must have voluntarily signed ICF and willing to complete the study procedure, after fully understanding of the study.
- Age ≥ 18 years and ≤ 75 years, male or female.
- The patients, with MM or Plasma Cell Leukemia, who have received regimens and have medical records in the past.
- According to the IMWG consensus for relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia, the disease is in a progressive state
- Subjects should have measurable disease.
- 5.1 Serum M protein ≥ 5 g / L;
Show all 14Show fewer
- 5.2 24-hour urinary M-protein ≥ 200 mg;
- 5.3 The serum free light chain (sFLC) ratio was abnormal and the involved FLC ≥ 100mg/L in patients with light chain multiple myeloma whose serum or urinary M protein levels did not meet the assessable criteria.
- 5.4 Circulating plasma cells ≥2%
- Expected survival > 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) scores 0-1.
- Subjects should have adequate function in hemostatic and liver and kidney.
- Women of childbearing age must undergo a serum pregnancy test with negative results at screening and before lymphodepletion and be willing to use an effective and reliable method of contraception for at least 1 year after study treatment. All female subjects are prohibited from egg donation within 1 year after study treatment.
- Men must be willing to use an effective and reliable method of contraception for at least 1 year after study treatment if they have sexual activity with women of childbearing potential. All male subjects are prohibited from sperm donation within 1 year after study treatment .
Who cannot join
- Pregnant or lactating women.
- Subjects positive for any following tests: human immunodeficiency virus (HIV) antibody, Treponema pallidum (syphilis) antibody, CMV（IgM），EBV;
- Active hepatitis B and/or active hepatitis C (HCV RNA positive); Those who are positive for hepatitis B surface antigen and/or core antibodies but whose HBV-DNA test is within normal limits may be enrolled.
- Subjects with any uncontrolled active infection (Except for prophylactic treatment).
- Subjects with AEs from previous treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤ 1, excluding hair loss and other events that the treating physician considers as tolerable.
- Subjects who have received autologous BCMA CAR-T therapy
Show all 20Show fewer
- Subjects who have received allogeneic stem cell transplantation for MM.
- Subjects who have received autologous stem cell transplantation less than 12 weeks before ICF.
- Subjects who have received any anti-MM treatment 14 days before ICF; the subjects are eligible to participate in the study regardless of the radiotherapy end date if the radiation area less than 5% of whole body.
- Subjects who have received systemic glucocorticoids within 7 days before infusion, except inhaled steroids.
- Subjects who have been received live attenuated vaccine within 8 weeks or inactivated vaccine within 4 weeks before lymphodepletion.
- Subjects have severe allergy history.
- Subjects who have any uncontrolled disease conditions within 6 months prior to the screening.
- LVEF < 50%
- Blood oxygen saturation that can only be maintained at > 95% by oxygen inhalation.
- Subjects known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other conditions that require long-term immunosuppressive therapy.
- Subjects with malignant tumors that have not been cured in the past 5 years or at the same time, except for very low malignant tumors.
- Subjects who have central nervous system (CNS) metastases or symptomatic CNS involvement.
- Subjects who are unable or unwilling to comply with the requirements of clinical trial or other reasons that are not suitable for participating in the clinical trial.
- Subjects who have received major surgery 2 weeks prior to the screening or plan to receive major surgery within 4 weeks after study treatment (excluding cataract and other local anesthesia).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, 200333
Aibin Liang, +8618601670600, lab7182@tongji.edu.cn
About this study
Official title: Open Label, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of CT0594CP in Patients With Relapsed and/or Refractory Multiple Myeloma or Plasma Cell Leukemia
This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT0594CP CAR-T Cells in patients with relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia
Read the detailed description
This is an open-label, single arm, dose-escalation clinical study, to evaluate the safety and tolerability of treatment with CT0594CP CAR-T Cells in patients with relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia
- Being tested
- Biological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiologicalOther
CT0594CP
| Study group | Role | What they receive |
|---|---|---|
| CT0594CP CAR-T Cells [BCMA-UCAR-T (CT0594)andCD94-UCAR-T(CT7590) ] | Experimental | CT0594CP Receives: Other: Biological |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability dose limiting toxicity
Safety and tolerability: dose limiting toxicity [Time Frame: 21-28 days post administration of CT0594CP ]
Measured: 21-28 days
Secondary outcomes (5)
Pharmacokinetics of CT0594CP CAR-T Cells (Tmax)
peak plasma Concentration time(Tmax), of after infusion CT0594CP CAR T Cells
Measured: From first dose of study drug adminisration to end of treatment (up to 12 months)
Pharmacokinetics of CT0594CP CAR-T Cells (Cmax)
peak plasma Concentration(Cmax), of after infusion CT0594CP CAR T Cells
Measured: From first dose of study drug adminisration to end of treatment (up to 12 months)
Pharmacokinetics of CT0594CP CAR-T Cells (AUC)
area under the Plasma concentration versus time curve (AUC), of after infusion CT0594CP CAR T Cells
Measured: From first dose of study drug adminisration to end of treatment (up to 12 months)
To evaluate the overall safety and tolerability of CT0594CP
Post-treatment Adverse events (TEAE) and incidence, Special Concern Adverse Events (AESI) and incidence, treatment-related adverse events
Measured: From first dose of study drug administration to end of treatment (up to 12 months)
To evaluate the initial efficacy of CT0594CP infusion in target subjects
Overall response rate (ORR)、 Complete response/strict complete response (CR/sCR) rate、Response rates of VGPR and above were achieved
、Duration of response (DOR)、Progression-free survival (PFS)、Overall survival (overall survival (OS)、Minimal residual disease (MRD) negative rate as measured by International Myeloma Working Group (IMWG) criteria after CT0594CP infusion
Measured: From first dose of study drug administration to end of treatment (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start12 Apr 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and/or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aibin Liang，MD，Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- CARsgen Therapeutics Co., Ltd.
- Responsible party
- Sponsor-investigator, Aibin Liang，MD，Ph.D., Shanghai Tongji Hospital, Tongji University School of Medicine
- Investigators
- Aibin Liang, Principal investigator, +8618601670600
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893693
- Sponsor's protocol ID
- CT0594CP-CG6020
- Status last verified
- May 2023
- First submitted
- 4 Apr 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of CT0594CP in Patients With Relapsed and/or Refractory Multiple Myeloma or Plasma Cell Leukemia
- ClinicalTrials.gov ID
- NCT05893693
- Acronym / sponsor ID
- CT0594CP-CG6020
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Aibin Liang，MD，Ph.D.University, hospital or other
- Collaborators
- CARsgen Therapeutics Co., Ltd.
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT0594CP CAR-T Cells in patients with relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia
Detailed description
This is an open-label, single arm, dose-escalation clinical study, to evaluate the safety and tolerability of treatment with CT0594CP CAR-T Cells in patients with relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT0594CP CAR-T Cells [BCMA-UCAR-T (CT0594)andCD94-UCAR-T(CT7590) ] | Experimental | Other: BiologicalCT0594CP |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients and legally acceptable representative must have voluntarily signed ICF and willing to complete the study procedure, after fully understanding of the study.
- Age ≥ 18 years and ≤ 75 years, male or female.
- The patients, with MM or Plasma Cell Leukemia, who have received regimens and have medical records in the past.
- According to the IMWG consensus for relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia, the disease is in a progressive state
- Subjects should have measurable disease.
Key exclusion criteria (20 listed)
- Pregnant or lactating women.
- Subjects positive for any following tests: human immunodeficiency virus (HIV) antibody, Treponema pallidum (syphilis) antibody, CMV（IgM），EBV;
- Active hepatitis B and/or active hepatitis C (HCV RNA positive); Those who are positive for hepatitis B surface antigen and/or core antibodies but whose HBV-DNA test is within normal limits may be enrolled.
- Subjects with any uncontrolled active infection (Except for prophylactic treatment).
- Subjects with AEs from previous treatment that have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) ≤ 1, excluding hair loss and other events that the treating physician considers as tolerable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiologicalCT0594CP | Other | CT0594CP CAR-T Cells [BCMA-UCAR-T (CT0594)andCD94-UCAR-T(CT7590) ] |
Primary outcome
Safety and tolerability dose limiting toxicity
Time frame: 21-28 days
Safety and tolerability: dose limiting toxicity [Time Frame: 21-28 days post administration of CT0594CP ]
5 secondary outcomes
Pharmacokinetics of CT0594CP CAR-T Cells (Tmax)
Time frame: From first dose of study drug adminisration to end of treatment (up to 12 months)
Pharmacokinetics of CT0594CP CAR-T Cells (Cmax)
Time frame: From first dose of study drug adminisration to end of treatment (up to 12 months)
Pharmacokinetics of CT0594CP CAR-T Cells (AUC)
Time frame: From first dose of study drug adminisration to end of treatment (up to 12 months)
To evaluate the overall safety and tolerability of CT0594CP
Time frame: From first dose of study drug administration to end of treatment (up to 12 months)
To evaluate the initial efficacy of CT0594CP infusion in target subjects
Time frame: From first dose of study drug administration to end of treatment (up to 12 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
Related trials for Relapsed and/or Refractory Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 1
A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
Relapsed or Refractory Multiple Myeloma
Active, not recruitingPhase 3
A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
Multiple Myeloma
RecruitingPhase 2
Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse
Recurrent Multiple Myeloma, Refractory Multiple Myeloma
RecruitingPhase 1
In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies
B-Acute Lymphoblastic Leukemia, B Cell Non-Hodgkin's Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aibin Liang principal investigator
+8618601670600
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biological in people with Relapsed and/or Refractory Multiple Myeloma and Plasma Cell Leukemia in Relapse, run by Aibin Liang，MD，Ph.D. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aibin Liang (+8618601670600, lab7182@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability dose limiting toxicity (time frame: 21-28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.