Multiple MyelomaPhase 1/2NCT06333509
Anti-GPRC5D CAR-T Cells (CT071) in Participants With RRMM or RRpPCL
A Phase 1/2 study testing CT071 in people with Multiple Myeloma and Primary Plasma Cell Leukemia, run by CARsgen Therapeutics Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Primary Plasma Cell Leukemia
- What is being tested?
- CT071
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2024to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1/2 Open Label Study to Evaluate the Safety and Efficacy of CT071, an Autologous Anti-GPRC5D CAR T, in Relapsed/Refractory Multiple Myeloma (RRMM) or Relapsed/Refractory Primary Plasma Cell Leukemia (RRpPCL)
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.
Read the 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.
- Conditions
- Multiple Myeloma, Primary Plasma Cell Leukemia
- Being tested
- CT071
- Keywords
- CAR-T, Multiple Myeloma, Primary plasma cell myeloma, CT071, GPRC5D, anti-GPRC5D, genetically modified T-cells, hematologic cancer
- Medical subject headings
- Multiple Myeloma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT071Biological
a single CAR-T infusion of CT071
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | Experimental | Dose Escalation followed a dose expansion. Receives: Biological: CT071 |
| Phase 2 | Experimental | Single group of patients for each indication (rrMM, RRpPCL). Receives: Biological: CT071 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Evaluation of the Safety of CT071 and determination of Maximum Tolerated Dose (MTD).
Frequency, type, and severity of AEs (SAEs, AESIs, laboratory abnormalities).
Measured: Day 1 - Month 24
Phase 2: Objective response rate
Objective response rate (ORR) per IMWG by IRC read; percentage of participants achieving confirmed PR or better per IMWG 2016 consensus criteria.
Measured: Day 1 - Month 24
Secondary outcomes (9)
Phase 1 and 2: Evaluate additional clinical efficacy outcomes
Overall Response Rate/Best Overall Response Rate by investigator (by IMWG stringent complete response/sCR, complete response/CR, very good partial response/VGPR, and partial response/PR by IRC and investigator assessment).
Measured: Day 1 - Month 24
Phase 1 and 2: Evaluate additional clinical efficacy outcomes
Duration of Response by IMWG (stringent complete response/sCR, complete response/CR, very good partial response/VGPR, and partial response/PR by IRC and investigator assessment).
Measured: Day 1 - Month 24
Phase 1 and 2: Evaluate additional clinical efficacy outcomes
Progression Free Survival by investigator assessment
Measured: Day 1 - Month 24
Phase 1 and 2: Evaluate additional clinical efficacy outcomes
Overall Survival
Measured: Day 1 - Month 24
Phase 2: Evaluate additional Safety of CT071.
Frequency, type, and severity of AEs (SAEs, AESIs, laboratory abnormalities).
Measured: Day 1 - Month 24
Phase 1 and 2: Assess immunogenicity of CT071
Percentage of patients with anti-CT071 drug antibodies
Measured: Day 1 - Month 60
Phase 1 and 2: Evaluate PK profile of CT071
CAR transgene copy peak value
Measured: Day 1 - Month 60
Phase 1 and 2: Evaluate PK profile of CT071
CAR transgene copy number persistence
Measured: Day 1 - Month 60
Phase 1 and 2: Evaluate PK profile of CT071
CAR transgene copy AUC
Measured: Day 1 - Month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start15 Apr 2024 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CARsgen Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06333509
- Sponsor's protocol ID
- CT071-HM-01
- Status last verified
- Mar 2024
- First submitted
- 19 Feb 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Open Label Study to Evaluate the Safety and Efficacy of CT071, an Autologous Anti-GPRC5D CAR T, in Relapsed/Refractory Multiple Myeloma (RRMM) or Relapsed/Refractory Primary Plasma Cell Leukemia (RRpPCL)
- ClinicalTrials.gov ID
- NCT06333509
- Acronym / sponsor ID
- CT071-HM-01
- Conditions
- Multiple Myeloma, Primary Plasma Cell Leukemia
- Keywords
- CAR-T, Multiple Myeloma, Primary plasma cell myeloma, CT071, GPRC5D, anti-GPRC5D, genetically modified T-cells, hematologic cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- CARsgen Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Mar 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | Experimental | Biological: CT071Dose Escalation followed a dose expansion. |
| Phase 2 | Experimental | Biological: CT071Single group of patients for each indication (rrMM, RRpPCL). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
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 |
|---|---|---|
| CT071a single CAR-T infusion of CT071 | Biological | Phase 1, Phase 2 |
Primary outcome
Phase 1: Evaluation of the Safety of CT071 and determination of Maximum Tolerated Dose (MTD).
Time frame: Day 1 - Month 24
Frequency, type, and severity of AEs (SAEs, AESIs, laboratory abnormalities).
Phase 2: Objective response rate
Time frame: Day 1 - Month 24
Objective response rate (ORR) per IMWG by IRC read; percentage of participants achieving confirmed PR or better per IMWG 2016 consensus criteria.
9 secondary outcomes
Phase 1 and 2: Evaluate additional clinical efficacy outcomes
Time frame: Day 1 - Month 24
Phase 1 and 2: Evaluate additional clinical efficacy outcomes
Time frame: Day 1 - Month 24
Phase 1 and 2: Evaluate additional clinical efficacy outcomes
Time frame: Day 1 - Month 24
Phase 1 and 2: Evaluate additional clinical efficacy outcomes
Time frame: Day 1 - Month 24
Phase 2: Evaluate additional Safety of CT071.
Time frame: Day 1 - Month 24
Phase 1 and 2: Assess immunogenicity of CT071
Time frame: Day 1 - Month 60
Phase 1 and 2: Evaluate PK profile of CT071
Time frame: Day 1 - Month 60
Phase 1 and 2: Evaluate PK profile of CT071
Time frame: Day 1 - Month 60
Phase 1 and 2: Evaluate PK profile of CT071
Time frame: Day 1 - Month 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CT071 in people with Multiple Myeloma and Primary Plasma Cell Leukemia, run by CARsgen Therapeutics Co., Ltd..
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 15 inclusion and 21 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: opening soon, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CARsgen US (CentralNumber, clinicalUS@carsgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Evaluation of the Safety of CT071 and determination of Maximum Tolerated Dose (MTD). (time frame: Day 1 - Month 24). The study lists 2 primary outcomes in all. 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 27 Mar 2024.